<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03789474</url>
  </required_header>
  <id_info>
    <org_study_id>AIIMSRishikesh</org_study_id>
    <nct_id>NCT03789474</nct_id>
  </id_info>
  <brief_title>Does Fluid Requirement Decrease With the Use of Pneumatic Compression Device on Lower Limbs</brief_title>
  <official_title>Impact of Intra-operative Use of Peristaltic Pneumatic Compression Device on Haemodynamics Vis-à-vis Fluid Requirement During General Anaesthesia and Surgery:A Randomized Prospective Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>All India Institute of Medical Sciences, Rishikesh</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>All India Institute of Medical Sciences, Rishikesh</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Impact of intraoperative use of pneumatic peristaltic compression device on hemodynamics vis&#xD;
      a vis on fluid requirement during general anaesthesia and surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Induction of general anaesthesia is associated with cardiac depression and peripheral&#xD;
      vasodilatation resulting in hypotension .This hypotension can be corrected by giving&#xD;
      intravenous fluid, or the vasoconstrictor. While optimum fluid balances in the perioperative&#xD;
      period is of vital importance in overnight fasting patients to correct the fluid deficit, any&#xD;
      fluid overload is not only counterproductive to the heart function but is associated with&#xD;
      fluid retention in body and edema in postoperative period.&#xD;
&#xD;
      Peristaltic pneumatic compression device, a variant of intermittent sequential compression of&#xD;
      legs, uses higher pressure and longer compression cycles to avoid venous stasis in&#xD;
      immobilized patients. Sequential compression devices have sleeves with pockets of inflation,&#xD;
      which works to squeeze on the appendage in a milking action .The most distal areas will&#xD;
      inflate initially, and the subsequent pockets will follow in the same manner. The primary aim&#xD;
      of the device is to squeeze blood from the underlying deep veins to proximal side. When the&#xD;
      inflatable sleeves deflate, the veins will replenish with blood. The intermittent&#xD;
      compressions of the sleeves will ensure the movement of venous blood . Peristaltic Pneumatic&#xD;
      Compression of the legs significantly reduces fluid demand and enhances stability during&#xD;
      minor ear, nose, and throat surgery. Peristaltic Pneumatic Compression has the potential to&#xD;
      support fluid restriction regimens during surgery .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Actual">July 30, 2018</completion_date>
  <primary_completion_date type="Actual">July 30, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>About 60 patients of age group 25 to 50 belonging to American Society of Anesthesiologists (ASA) grade 1 and 2 were allocated to either control or sequential pneumatic compression device group .Allocation was done by sealed envelop technique.In the operating room,in the control group,the device was placed on operating table and was placed next to the patients calves.in the intervention group,the device was placed over calves and inflated during induction of General Anaesthesia (GA) and maintenance.legs were draped in both the groups.Femoral vein velocities were assessed using ultrasound in preoperative period , intraoperatively 15 minutes after induction of anaesthesia and in post-operative period.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
    <masking_description>Draping of the legs was done in both the groups.the care observer nor investigator were blinded for the allocation.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Heart Rate at T0</measure>
    <time_frame>15 minutes pre induction</time_frame>
    <description>heart rate monitoring at T0</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Heart Rate at T1</measure>
    <time_frame>post induction heart rate</time_frame>
    <description>heart rate monitoring at T1</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Heart Rate at T2</measure>
    <time_frame>15 minutes after induction</time_frame>
    <description>heart rate monitoring at T2</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Heart Rate at T3</measure>
    <time_frame>30 minutes after induction</time_frame>
    <description>heart rate monitoring at T3</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Heart Rate at T4</measure>
    <time_frame>60 minutes after induction</time_frame>
    <description>heart rate monitoring at T4</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Heart Rate at T5</measure>
    <time_frame>120 minutes after induction</time_frame>
    <description>heart rate monitoring at T5</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Heart Rate at T6</measure>
    <time_frame>post operative period after 30 min in post anaesthesia care unit</time_frame>
    <description>heart rate monitoring at T6</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Systolic Blood Pressure at T0</measure>
    <time_frame>15 min before induction</time_frame>
    <description>systolic blood pressure measurement at T0</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Systolic Blood Pressure at T1</measure>
    <time_frame>post induction</time_frame>
    <description>systolic blood pressure measurement at T1</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Systolic Blood Pressure at T2</measure>
    <time_frame>15 min after induction</time_frame>
    <description>systolic blood pressure measurement at T2</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Systolic Blood Pressure at T3</measure>
    <time_frame>30 min after induction</time_frame>
    <description>systolic blood pressure measurement at T3</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Systolic Blood Pressure at T4</measure>
    <time_frame>60 min after induction</time_frame>
    <description>systolic blood pressure measurement at T4</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Systolic Blood Pressure at T5</measure>
    <time_frame>120 min after induction</time_frame>
    <description>systolic blood pressure measurement at T5</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Systolic Blood Pressure at T6</measure>
    <time_frame>post operative period 30 min in post asnaesthesia care unit</time_frame>
    <description>systolic blood pressure measurement at T6</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Diastolic Blood Presure at T0</measure>
    <time_frame>15 minutes before induction</time_frame>
    <description>Diastolic blood pressure measurement at T0</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Diastolic Blood Pressure at T1</measure>
    <time_frame>immediately after induction</time_frame>
    <description>Diastolic blood pressure measurement at T1</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Diastolic Blood Pressure at T2</measure>
    <time_frame>15 minutes after induction</time_frame>
    <description>Diastolic blood pressure measurement at T2</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Diastolic Blood Pressure at T3</measure>
    <time_frame>30 minutes after induction</time_frame>
    <description>Diastolic blood pressure measurement at T3</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Diastolic Blood Pressure at T4</measure>
    <time_frame>60 minutes after induction</time_frame>
    <description>Diastolic blood pressure measurement at T4</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Diastolic Blood Pressure at T5</measure>
    <time_frame>120 minutes after induction</time_frame>
    <description>Diastolic blood pressure measurement at T5</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Diastolic Blood Pressure at T6</measure>
    <time_frame>post induction 30 min in post anaesthesia care unit</time_frame>
    <description>Diastolic blood pressure measurement at T6</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Blood Pressure at T0</measure>
    <time_frame>15 minutes pre induction</time_frame>
    <description>Mean blood pressure measurement at T0</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Blood Pressure at T1</measure>
    <time_frame>immediately after induction</time_frame>
    <description>Mean blood pressure measurement at T1</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Blood Pressure at T2</measure>
    <time_frame>15 minutes after induction</time_frame>
    <description>Mean blood pressure measurement at T2</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Blood Pressure at T3</measure>
    <time_frame>30 minutes after induction</time_frame>
    <description>Mean blood pressure measurement at T3</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Blood Pressure at T4</measure>
    <time_frame>60 minutes after induction</time_frame>
    <description>Mean blood pressure measurement at T4</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Blood Pressure at T5</measure>
    <time_frame>120 minutes after induction</time_frame>
    <description>Mean blood pressure measurement at T5</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Blood Pressure at T6</measure>
    <time_frame>post operative 30 min in post anaesthesia care unit</time_frame>
    <description>Mean blood pressure measurement at T6</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Femoral Vein Velocity at T0</measure>
    <time_frame>15 minutes pre induction</time_frame>
    <description>Femoral vein velocity measuement at T0</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Femoral Vein Velocity at T2</measure>
    <time_frame>15 minutes after induction</time_frame>
    <description>Femoral vein velocity measurement at T2</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Femoral Vein Velocity at T6</measure>
    <time_frame>after 30 minutes in post anaesthesia care unit</time_frame>
    <description>Femoral vein velocity measurement at T6</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Femoral Vein Velocity Variance</measure>
    <time_frame>15 minutes pre induction to 30 minutes in post anaesthesia care unit</time_frame>
    <description>the variance in femoral vein velocity was calculated by subtracting the femoral vein velocity pre induction from femoral vein velocity 15 min after induction divided by mean of the two values in percentage</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Femoral Artery Velocity at T0</measure>
    <time_frame>15 minutes pre induction</time_frame>
    <description>Femoral artery velocity measurement at T0</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Femoral Artery Velocity at T2</measure>
    <time_frame>15 minutes after induction</time_frame>
    <description>Femoral artery velocity measurement at T2</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Femoral Artery Velocity at T6</measure>
    <time_frame>after 30 minutes in post anaesthesia care unit</time_frame>
    <description>Femoral artery velocity measurement at T6</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Inferior Venacava Diameter (Maximum) at T0</measure>
    <time_frame>15 min pre induction</time_frame>
    <description>inferior venacava diameter (maximum) meaurement at T0</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Inferior Venacava Diameter (Maximum) at T2</measure>
    <time_frame>15 min after induction</time_frame>
    <description>inferior venacava diameter (maximum) meaurement at T2</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Inferior Venacava Diameter (Maximum) at T6</measure>
    <time_frame>after 30 min in post anaesthesia care unit</time_frame>
    <description>inferior venacava diameter (maximum) meaurement at T6</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Inferior Venacava Diameter (Minimum) at T0</measure>
    <time_frame>15 min pre induction</time_frame>
    <description>inferior venacava diameter (minimum) meaurement at T0</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Inferior Venacava Diameter (Minimum) at T2</measure>
    <time_frame>15 min after induction</time_frame>
    <description>inferior venacava diameter (minimum) meaurement at T2</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Inferior Venacava Diameter (Minimum) at T6</measure>
    <time_frame>after 30 min in post anaesthesia care unit</time_frame>
    <description>inferior venacava diameter (minimum) meaurement at T6</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Inferior Venacava Diameter Collapsibility Index at T0</measure>
    <time_frame>15 min pre induction</time_frame>
    <description>the collapsibility index was calculated by dividing the difference of maximum inferior vena cava diameter and minimum inferior vena cava diameter by mean of the two diameters multiplied by 100.This was done for pre induction spontaneously breathing patients</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Inferior Venacava Diameter Distensibility Index at T2</measure>
    <time_frame>15 min after induction</time_frame>
    <description>the inferior venacava distensibility index for post induction mechanically ventilated patients. It was calculated by dividing the difference of maximum inferior vena cava diameter and minimum inferior vena cava diameter by minimum inferior vena cava diameters multiplied by 100 .</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Inferior Venacava Diameter Collapsibility Index at T6</measure>
    <time_frame>after 30 minutes in post anaesthesia care unit</time_frame>
    <description>the collapsibility index was calculated by dividing the difference of maximum inferior vena cava diameter and minimum inferior vena cava diameter by mean of the two diameters multiplied by 100.This was done for pre induction spontaneously breathing patients</description>
  </primary_outcome>
  <primary_outcome>
    <measure>FLUID REQUIREMENT (Cumulative)</measure>
    <time_frame>operative period</time_frame>
    <description>fluid requirement (cumulative) during the operative period.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Blood Loss During Operation</measure>
    <time_frame>During operating procedure</time_frame>
    <description>Total blood loss during operation</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Fluid Overload</condition>
  <arm_group>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No intervention was done ,served as a control group.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention:peristaltic pneumatic compression device was placed on the legs of the patient and was active. HUNTLEIGH FLOWTRON ACS900 calf length device was used.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>HUNTLEIGH FLOWTRON ACS900</intervention_name>
    <arm_group_label>Group B</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA(American Society of Anaesthesiologists) grade I or II, of both genders&#xD;
&#xD;
          -  Age group of 25 to 50 years&#xD;
&#xD;
          -  Patients undergoing surgeries under GA(General Anaesthesia) for 2-3 hours&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients expected to get major blood loss&#xD;
&#xD;
          -  Burns patients.&#xD;
&#xD;
          -  Patients with significant cardiac diseases.&#xD;
&#xD;
          -  Patients with pulmonary diseases and impaired renal function.&#xD;
&#xD;
          -  Lower limb surgeries and abdominal surgeries&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mukesh Tripathi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>All India Institute of Medical Sciences, Rishikesh</affiliation>
  </overall_official>
  <results_reference>
    <citation>Kiefer N, Theis J, Putensen-Himmer G, Hoeft A, Zenker S. Peristaltic pneumatic compression of the legs reduces fluid demand and improves hemodynamic stability during surgery: a randomized, prospective study. Anesthesiology. 2011 Mar;114(3):536-44. doi: 10.1097/ALN.0b013e31820c3973.</citation>
    <PMID>21307764</PMID>
  </results_reference>
  <results_reference>
    <citation>Kaufmann KB, Stein L, Bogatyreva L, Ulbrich F, Kaifi JT, Hauschke D, Loop T, Goebel U. Oesophageal Doppler guided goal-directed haemodynamic therapy in thoracic surgery - a single centre randomized parallel-arm trial. Br J Anaesth. 2017 Jun 1;118(6):852-861. doi: 10.1093/bja/aew447.</citation>
    <PMID>28575331</PMID>
  </results_reference>
  <results_reference>
    <citation>Meng L, Heerdt PM. Perioperative goal-directed haemodynamic therapy based on flow parameters: a concept in evolution. Br J Anaesth. 2016 Dec;117(suppl 3):iii3-iii17. doi: 10.1093/bja/aew363.</citation>
    <PMID>27940452</PMID>
  </results_reference>
  <results_reference>
    <citation>Millard JA, Hill BB, Cook PS, Fenoglio ME, Stahlgren LH. Intermittent sequential pneumatic compression in prevention of venous stasis associated with pneumoperitoneum during laparoscopic cholecystectomy. Arch Surg. 1993 Aug;128(8):914-8; discussion 918-9. doi: 10.1001/archsurg.1993.01420200088016.</citation>
    <PMID>8343064</PMID>
  </results_reference>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>December 27, 2018</study_first_submitted>
  <study_first_submitted_qc>December 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 28, 2018</study_first_posted>
  <results_first_submitted>May 5, 2020</results_first_submitted>
  <results_first_submitted_qc>August 11, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">August 21, 2020</results_first_posted>
  <last_update_submitted>August 11, 2020</last_update_submitted>
  <last_update_submitted_qc>August 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 21, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>All India Institute of Medical Sciences, Rishikesh</investigator_affiliation>
    <investigator_full_name>Dr. Masaipeta Kesari</investigator_full_name>
    <investigator_title>Junior resident,Principal Investigator,Department of Anaesthesiology, All India institute of Medical Sciences, Rishikesh.</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>study protocol,stastical analysis plan,informed consent form.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>june 2020 till june 2021</ipd_time_frame>
    <ipd_access_criteria>after obtaining consent.</ipd_access_criteria>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol, Statistical Analysis Plan, and Informed Consent Form</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>December 21, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/74/NCT03789474/Prot_SAP_ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The study was conducted from January 2017 to July 2018 at ALL INDIA INSTITUTE OF MEDICAL SCIENCES,RISHIKESH,UTTARAKHAND ,INDIA.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Group A</title>
          <description>No intervention was done ,served as a control group.</description>
        </group>
        <group group_id="P2">
          <title>Group B</title>
          <description>Intervention:peristaltic pneumatic compression device was placed on the legs of the patient and was active. HUNTLEIGH FLOWTRON ACS900 calf length device was used.&#xD;
HUNTLEIGH FLOWTRON ACS900</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Group A</title>
          <description>No intervention was done ,served as a control group.</description>
        </group>
        <group group_id="B2">
          <title>Group B</title>
          <description>Intervention:peristaltic pneumatic compression device was placed on the legs of the patient and was active. HUNTLEIGH FLOWTRON ACS900 calf length device was used.&#xD;
HUNTLEIGH FLOWTRON ACS900</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="30"/>
            <count group_id="B2" value="30"/>
            <count group_id="B3" value="60"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="30"/>
                    <count group_id="B2" value="30"/>
                    <count group_id="B3" value="60"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="36.4" spread="9.4"/>
                    <measurement group_id="B2" value="34.1" spread="7.6"/>
                    <measurement group_id="B3" value="35.2" spread="8.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="30"/>
                    <count group_id="B2" value="30"/>
                    <count group_id="B3" value="60"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="37"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Height</title>
          <description>in meters</description>
          <units>meters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="30"/>
                    <count group_id="B2" value="30"/>
                    <count group_id="B3" value="60"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1.62" spread=".1"/>
                    <measurement group_id="B2" value="1.59" spread=".1"/>
                    <measurement group_id="B3" value="1.60" spread=".1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <description>in kilograms</description>
          <units>kilograms</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="30"/>
                    <count group_id="B2" value="30"/>
                    <count group_id="B3" value="60"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="60.77" spread="8.73"/>
                    <measurement group_id="B2" value="62.13" spread="9.1"/>
                    <measurement group_id="B3" value="61.45" spread="8.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index (BMI)</title>
          <units>kg^m2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="30"/>
                    <count group_id="B2" value="30"/>
                    <count group_id="B3" value="60"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="22.8" spread="3.74"/>
                    <measurement group_id="B2" value="24.5" spread="4.2"/>
                    <measurement group_id="B3" value="23.65" spread="3.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Heart Rate at T0</title>
        <description>heart rate monitoring at T0</description>
        <time_frame>15 minutes pre induction</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group A</title>
            <description>No intervention was done ,served as a control group.</description>
          </group>
          <group group_id="O2">
            <title>Group B</title>
            <description>Intervention:peristaltic pneumatic compression device was placed on the legs of the patient and was active. HUNTLEIGH FLOWTRON ACS900 calf length device was used.&#xD;
HUNTLEIGH FLOWTRON ACS900</description>
          </group>
        </group_list>
        <measure>
          <title>Heart Rate at T0</title>
          <description>heart rate monitoring at T0</description>
          <units>beats per minute</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="85.23" spread="17.81"/>
                    <measurement group_id="O2" value="88.833" spread="18.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.443</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Heart Rate at T1</title>
        <description>heart rate monitoring at T1</description>
        <time_frame>post induction heart rate</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group A</title>
            <description>No intervention was done ,served as a control group.</description>
          </group>
          <group group_id="O2">
            <title>Group B</title>
            <description>Intervention:peristaltic pneumatic compression device was placed on the legs of the patient and was active. HUNTLEIGH FLOWTRON ACS900 calf length device was used.&#xD;
HUNTLEIGH FLOWTRON ACS900</description>
          </group>
        </group_list>
        <measure>
          <title>Heart Rate at T1</title>
          <description>heart rate monitoring at T1</description>
          <units>beats per minute</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79.60" spread="16.44"/>
                    <measurement group_id="O2" value="88.13" spread="18.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.063</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Heart Rate at T2</title>
        <description>heart rate monitoring at T2</description>
        <time_frame>15 minutes after induction</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group A</title>
            <description>No intervention was done ,served as a control group.</description>
          </group>
          <group group_id="O2">
            <title>Group B</title>
            <description>Intervention:peristaltic pneumatic compression device was placed on the legs of the patient and was active. HUNTLEIGH FLOWTRON ACS900 calf length device was used.&#xD;
HUNTLEIGH FLOWTRON ACS900</description>
          </group>
        </group_list>
        <measure>
          <title>Heart Rate at T2</title>
          <description>heart rate monitoring at T2</description>
          <units>beats per minute</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79.97" spread="13.26"/>
                    <measurement group_id="O2" value="88.57" spread="20.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.057</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Heart Rate at T3</title>
        <description>heart rate monitoring at T3</description>
        <time_frame>30 minutes after induction</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group A</title>
            <description>No intervention was done ,served as a control group.</description>
          </group>
          <group group_id="O2">
            <title>Group B</title>
            <description>Intervention:peristaltic pneumatic compression device was placed on the legs of the patient and was active. HUNTLEIGH FLOWTRON ACS900 calf length device was used.&#xD;
HUNTLEIGH FLOWTRON ACS900</description>
          </group>
        </group_list>
        <measure>
          <title>Heart Rate at T3</title>
          <description>heart rate monitoring at T3</description>
          <units>beats per minute</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76.70" spread="12.26"/>
                    <measurement group_id="O2" value="84.77" spread="16.80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.038</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Heart Rate at T4</title>
        <description>heart rate monitoring at T4</description>
        <time_frame>60 minutes after induction</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group A</title>
            <description>No intervention was done ,served as a control group.</description>
          </group>
          <group group_id="O2">
            <title>Group B</title>
            <description>Intervention:peristaltic pneumatic compression device was placed on the legs of the patient and was active. HUNTLEIGH FLOWTRON ACS900 calf length device was used.&#xD;
HUNTLEIGH FLOWTRON ACS900</description>
          </group>
        </group_list>
        <measure>
          <title>Heart Rate at T4</title>
          <description>heart rate monitoring at T4</description>
          <units>beats per minute</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77.40" spread="10.93"/>
                    <measurement group_id="O2" value="83.56" spread="14.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.072</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Heart Rate at T5</title>
        <description>heart rate monitoring at T5</description>
        <time_frame>120 minutes after induction</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group A</title>
            <description>No intervention was done ,served as a control group.</description>
          </group>
          <group group_id="O2">
            <title>Group B</title>
            <description>Intervention:peristaltic pneumatic compression device was placed on the legs of the patient and was active. HUNTLEIGH FLOWTRON ACS900 calf length device was used.&#xD;
HUNTLEIGH FLOWTRON ACS900</description>
          </group>
        </group_list>
        <measure>
          <title>Heart Rate at T5</title>
          <description>heart rate monitoring at T5</description>
          <units>beats per minute</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77.53" spread="12.71"/>
                    <measurement group_id="O2" value="82.17" spread="14.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.189</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Heart Rate at T6</title>
        <description>heart rate monitoring at T6</description>
        <time_frame>post operative period after 30 min in post anaesthesia care unit</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group A</title>
            <description>No intervention was done ,served as a control group.</description>
          </group>
          <group group_id="O2">
            <title>Group B</title>
            <description>Intervention:peristaltic pneumatic compression device was placed on the legs of the patient and was active. HUNTLEIGH FLOWTRON ACS900 calf length device was used.&#xD;
HUNTLEIGH FLOWTRON ACS900</description>
          </group>
        </group_list>
        <measure>
          <title>Heart Rate at T6</title>
          <description>heart rate monitoring at T6</description>
          <units>beats per minute</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="85.06" spread="12.58"/>
                    <measurement group_id="O2" value="88.23" spread="13.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.358</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Systolic Blood Pressure at T0</title>
        <description>systolic blood pressure measurement at T0</description>
        <time_frame>15 min before induction</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group A</title>
            <description>No intervention was done ,served as a control group.</description>
          </group>
          <group group_id="O2">
            <title>Group B</title>
            <description>Intervention:peristaltic pneumatic compression device was placed on the legs of the patient and was active. HUNTLEIGH FLOWTRON ACS900 calf length device was used.&#xD;
HUNTLEIGH FLOWTRON ACS900</description>
          </group>
        </group_list>
        <measure>
          <title>Systolic Blood Pressure at T0</title>
          <description>systolic blood pressure measurement at T0</description>
          <units>millimeters of mercury</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="119.06" spread="11.71"/>
                    <measurement group_id="O2" value="122.1" spread="16.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.406</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Systolic Blood Pressure at T1</title>
        <description>systolic blood pressure measurement at T1</description>
        <time_frame>post induction</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group A</title>
            <description>No intervention was done ,served as a control group.</description>
          </group>
          <group group_id="O2">
            <title>Group B</title>
            <description>Intervention:peristaltic pneumatic compression device was placed on the legs of the patient and was active. HUNTLEIGH FLOWTRON ACS900 calf length device was used.&#xD;
HUNTLEIGH FLOWTRON ACS900</description>
          </group>
        </group_list>
        <measure>
          <title>Systolic Blood Pressure at T1</title>
          <description>systolic blood pressure measurement at T1</description>
          <units>millimeters of mercury</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="102.33" spread="15.31"/>
                    <measurement group_id="O2" value="106.80" spread="14.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.256</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Systolic Blood Pressure at T2</title>
        <description>systolic blood pressure measurement at T2</description>
        <time_frame>15 min after induction</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group A</title>
            <description>No intervention was done ,served as a control group.</description>
          </group>
          <group group_id="O2">
            <title>Group B</title>
            <description>Intervention:peristaltic pneumatic compression device was placed on the legs of the patient and was active. HUNTLEIGH FLOWTRON ACS900 calf length device was used.&#xD;
HUNTLEIGH FLOWTRON ACS900</description>
          </group>
        </group_list>
        <measure>
          <title>Systolic Blood Pressure at T2</title>
          <description>systolic blood pressure measurement at T2</description>
          <units>millimeters of mercury</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.73" spread="12.12"/>
                    <measurement group_id="O2" value="106.93" spread="13.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.066</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Systolic Blood Pressure at T3</title>
        <description>systolic blood pressure measurement at T3</description>
        <time_frame>30 min after induction</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group A</title>
            <description>No intervention was done ,served as a control group.</description>
          </group>
          <group group_id="O2">
            <title>Group B</title>
            <description>Intervention:peristaltic pneumatic compression device was placed on the legs of the patient and was active. HUNTLEIGH FLOWTRON ACS900 calf length device was used.&#xD;
HUNTLEIGH FLOWTRON ACS900</description>
          </group>
        </group_list>
        <measure>
          <title>Systolic Blood Pressure at T3</title>
          <description>systolic blood pressure measurement at T3</description>
          <units>millimeters of mercury</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="106.23" spread="15.08"/>
                    <measurement group_id="O2" value="109.90" spread="12.93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.316</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Systolic Blood Pressure at T4</title>
        <description>systolic blood pressure measurement at T4</description>
        <time_frame>60 min after induction</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group A</title>
            <description>No intervention was done ,served as a control group.</description>
          </group>
          <group group_id="O2">
            <title>Group B</title>
            <description>Intervention:peristaltic pneumatic compression device was placed on the legs of the patient and was active. HUNTLEIGH FLOWTRON ACS900 calf length device was used.&#xD;
HUNTLEIGH FLOWTRON ACS900</description>
          </group>
        </group_list>
        <measure>
          <title>Systolic Blood Pressure at T4</title>
          <description>systolic blood pressure measurement at T4</description>
          <units>millimeters of mercury</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="111.10" spread="15.59"/>
                    <measurement group_id="O2" value="111.23" spread="12.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.971</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Systolic Blood Pressure at T5</title>
        <description>systolic blood pressure measurement at T5</description>
        <time_frame>120 min after induction</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group A</title>
            <description>No intervention was done ,served as a control group.</description>
          </group>
          <group group_id="O2">
            <title>Group B</title>
            <description>Intervention:peristaltic pneumatic compression device was placed on the legs of the patient and was active. HUNTLEIGH FLOWTRON ACS900 calf length device was used.&#xD;
HUNTLEIGH FLOWTRON ACS900</description>
          </group>
        </group_list>
        <measure>
          <title>Systolic Blood Pressure at T5</title>
          <description>systolic blood pressure measurement at T5</description>
          <units>millimeters of mercury</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="108.86" spread="10.92"/>
                    <measurement group_id="O2" value="115.70" spread="12.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.030</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Systolic Blood Pressure at T6</title>
        <description>systolic blood pressure measurement at T6</description>
        <time_frame>post operative period 30 min in post asnaesthesia care unit</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group A</title>
            <description>No intervention was done ,served as a control group.</description>
          </group>
          <group group_id="O2">
            <title>Group B</title>
            <description>Intervention:peristaltic pneumatic compression device was placed on the legs of the patient and was active. HUNTLEIGH FLOWTRON ACS900 calf length device was used.&#xD;
HUNTLEIGH FLOWTRON ACS900</description>
          </group>
        </group_list>
        <measure>
          <title>Systolic Blood Pressure at T6</title>
          <description>systolic blood pressure measurement at T6</description>
          <units>millimeters of mercury</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="118.80" spread="10.34"/>
                    <measurement group_id="O2" value="126.03" spread="10.49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.009</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Diastolic Blood Presure at T0</title>
        <description>Diastolic blood pressure measurement at T0</description>
        <time_frame>15 minutes before induction</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group A</title>
            <description>No intervention was done ,served as a control group.</description>
          </group>
          <group group_id="O2">
            <title>Group B</title>
            <description>Intervention:peristaltic pneumatic compression device was placed on the legs of the patient and was active. HUNTLEIGH FLOWTRON ACS900 calf length device was used.&#xD;
HUNTLEIGH FLOWTRON ACS900</description>
          </group>
        </group_list>
        <measure>
          <title>Diastolic Blood Presure at T0</title>
          <description>Diastolic blood pressure measurement at T0</description>
          <units>millimeters of mercury</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76.00" spread="11.66"/>
                    <measurement group_id="O2" value="72.23" spread="13.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.704</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Diastolic Blood Pressure at T1</title>
        <description>Diastolic blood pressure measurement at T1</description>
        <time_frame>immediately after induction</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group A</title>
            <description>No intervention was done ,served as a control group.</description>
          </group>
          <group group_id="O2">
            <title>Group B</title>
            <description>Intervention:peristaltic pneumatic compression device was placed on the legs of the patient and was active. HUNTLEIGH FLOWTRON ACS900 calf length device was used.&#xD;
HUNTLEIGH FLOWTRON ACS900</description>
          </group>
        </group_list>
        <measure>
          <title>Diastolic Blood Pressure at T1</title>
          <description>Diastolic blood pressure measurement at T1</description>
          <units>millimeters of mercury</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.30" spread="12.93"/>
                    <measurement group_id="O2" value="69.33" spread="11.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.350</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Diastolic Blood Pressure at T2</title>
        <description>Diastolic blood pressure measurement at T2</description>
        <time_frame>15 minutes after induction</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group A</title>
            <description>No intervention was done ,served as a control group.</description>
          </group>
          <group group_id="O2">
            <title>Group B</title>
            <description>Intervention:peristaltic pneumatic compression device was placed on the legs of the patient and was active. HUNTLEIGH FLOWTRON ACS900 calf length device was used.&#xD;
HUNTLEIGH FLOWTRON ACS900</description>
          </group>
        </group_list>
        <measure>
          <title>Diastolic Blood Pressure at T2</title>
          <description>Diastolic blood pressure measurement at T2</description>
          <units>millimeters of mercury</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65.37" spread="11.66"/>
                    <measurement group_id="O2" value="66.53" spread="12.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.708</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Diastolic Blood Pressure at T3</title>
        <description>Diastolic blood pressure measurement at T3</description>
        <time_frame>30 minutes after induction</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group A</title>
            <description>No intervention was done ,served as a control group.</description>
          </group>
          <group group_id="O2">
            <title>Group B</title>
            <description>Intervention:peristaltic pneumatic compression device was placed on the legs of the patient and was active. HUNTLEIGH FLOWTRON ACS900 calf length device was used.&#xD;
HUNTLEIGH FLOWTRON ACS900</description>
          </group>
        </group_list>
        <measure>
          <title>Diastolic Blood Pressure at T3</title>
          <description>Diastolic blood pressure measurement at T3</description>
          <units>millimeters of mercury</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69.46" spread="15.42"/>
                    <measurement group_id="O2" value="68.13" spread="12.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.711</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Diastolic Blood Pressure at T4</title>
        <description>Diastolic blood pressure measurement at T4</description>
        <time_frame>60 minutes after induction</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group A</title>
            <description>No intervention was done ,served as a control group.</description>
          </group>
          <group group_id="O2">
            <title>Group B</title>
            <description>Intervention:peristaltic pneumatic compression device was placed on the legs of the patient and was active. HUNTLEIGH FLOWTRON ACS900 calf length device was used.&#xD;
HUNTLEIGH FLOWTRON ACS900</description>
          </group>
        </group_list>
        <measure>
          <title>Diastolic Blood Pressure at T4</title>
          <description>Diastolic blood pressure measurement at T4</description>
          <units>millimeters of mercury</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69.36" spread="16.75"/>
                    <measurement group_id="O2" value="69.16" spread="10.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.956</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Diastolic Blood Pressure at T5</title>
        <description>Diastolic blood pressure measurement at T5</description>
        <time_frame>120 minutes after induction</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group A</title>
            <description>No intervention was done ,served as a control group.</description>
          </group>
          <group group_id="O2">
            <title>Group B</title>
            <description>Intervention:peristaltic pneumatic compression device was placed on the legs of the patient and was active. HUNTLEIGH FLOWTRON ACS900 calf length device was used.&#xD;
HUNTLEIGH FLOWTRON ACS900</description>
          </group>
        </group_list>
        <measure>
          <title>Diastolic Blood Pressure at T5</title>
          <description>Diastolic blood pressure measurement at T5</description>
          <units>millimeters of mercury</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.63" spread="11.53"/>
                    <measurement group_id="O2" value="70.80" spread="9.93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.139</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Diastolic Blood Pressure at T6</title>
        <description>Diastolic blood pressure measurement at T6</description>
        <time_frame>post induction 30 min in post anaesthesia care unit</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group A</title>
            <description>No intervention was done ,served as a control group.</description>
          </group>
          <group group_id="O2">
            <title>Group B</title>
            <description>Intervention:peristaltic pneumatic compression device was placed on the legs of the patient and was active. HUNTLEIGH FLOWTRON ACS900 calf length device was used.&#xD;
HUNTLEIGH FLOWTRON ACS900</description>
          </group>
        </group_list>
        <measure>
          <title>Diastolic Blood Pressure at T6</title>
          <description>Diastolic blood pressure measurement at T6</description>
          <units>millimeters of mercury</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70.66" spread="9.80"/>
                    <measurement group_id="O2" value="75.80" spread="8.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.035</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Mean Blood Pressure at T0</title>
        <description>Mean blood pressure measurement at T0</description>
        <time_frame>15 minutes pre induction</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group A</title>
            <description>No intervention was done ,served as a control group.</description>
          </group>
          <group group_id="O2">
            <title>Group B</title>
            <description>Intervention:peristaltic pneumatic compression device was placed on the legs of the patient and was active. HUNTLEIGH FLOWTRON ACS900 calf length device was used.&#xD;
HUNTLEIGH FLOWTRON ACS900</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Blood Pressure at T0</title>
          <description>Mean blood pressure measurement at T0</description>
          <units>millimeters of mercury</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.04" spread="11.03"/>
                    <measurement group_id="O2" value="92.19" spread="13.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.502</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Mean Blood Pressure at T1</title>
        <description>Mean blood pressure measurement at T1</description>
        <time_frame>immediately after induction</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group A</title>
            <description>No intervention was done ,served as a control group.</description>
          </group>
          <group group_id="O2">
            <title>Group B</title>
            <description>Intervention:peristaltic pneumatic compression device was placed on the legs of the patient and was active. HUNTLEIGH FLOWTRON ACS900 calf length device was used.&#xD;
HUNTLEIGH FLOWTRON ACS900</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Blood Pressure at T1</title>
          <description>Mean blood pressure measurement at T1</description>
          <units>millimeters of mercury</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="78.38" spread="13.29"/>
                    <measurement group_id="O2" value="81.82" spread="11.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.350</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Mean Blood Pressure at T2</title>
        <description>Mean blood pressure measurement at T2</description>
        <time_frame>15 minutes after induction</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group A</title>
            <description>No intervention was done ,served as a control group.</description>
          </group>
          <group group_id="O2">
            <title>Group B</title>
            <description>Intervention:peristaltic pneumatic compression device was placed on the legs of the patient and was active. HUNTLEIGH FLOWTRON ACS900 calf length device was used.&#xD;
HUNTLEIGH FLOWTRON ACS900</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Blood Pressure at T2</title>
          <description>Mean blood pressure measurement at T2</description>
          <units>millimeters of mercury</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77.38" spread="11.46"/>
                    <measurement group_id="O2" value="79.99" spread="11.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.380</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Mean Blood Pressure at T3</title>
        <description>Mean blood pressure measurement at T3</description>
        <time_frame>30 minutes after induction</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group A</title>
            <description>No intervention was done ,served as a control group.</description>
          </group>
          <group group_id="O2">
            <title>Group B</title>
            <description>Intervention:peristaltic pneumatic compression device was placed on the legs of the patient and was active. HUNTLEIGH FLOWTRON ACS900 calf length device was used.&#xD;
HUNTLEIGH FLOWTRON ACS900</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Blood Pressure at T3</title>
          <description>Mean blood pressure measurement at T3</description>
          <units>millimeters of mercury</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82.42" spread="14.36"/>
                    <measurement group_id="O2" value="82.05" spread="11.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.914</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Mean Blood Pressure at T4</title>
        <description>Mean blood pressure measurement at T4</description>
        <time_frame>60 minutes after induction</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group A</title>
            <description>No intervention was done ,served as a control group.</description>
          </group>
          <group group_id="O2">
            <title>Group B</title>
            <description>Intervention:peristaltic pneumatic compression device was placed on the legs of the patient and was active. HUNTLEIGH FLOWTRON ACS900 calf length device was used.&#xD;
HUNTLEIGH FLOWTRON ACS900</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Blood Pressure at T4</title>
          <description>Mean blood pressure measurement at T4</description>
          <units>millimeters of mercury</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="83.55" spread="15.79"/>
                    <measurement group_id="O2" value="83.19" spread="10.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.915</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Mean Blood Pressure at T5</title>
        <description>Mean blood pressure measurement at T5</description>
        <time_frame>120 minutes after induction</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group A</title>
            <description>No intervention was done ,served as a control group.</description>
          </group>
          <group group_id="O2">
            <title>Group B</title>
            <description>Intervention:peristaltic pneumatic compression device was placed on the legs of the patient and was active. HUNTLEIGH FLOWTRON ACS900 calf length device was used.&#xD;
HUNTLEIGH FLOWTRON ACS900</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Blood Pressure at T5</title>
          <description>Mean blood pressure measurement at T5</description>
          <units>millimeters of mercury</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="81.16" spread="10.64"/>
                    <measurement group_id="O2" value="85.76" spread="9.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.087</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Mean Blood Pressure at T6</title>
        <description>Mean blood pressure measurement at T6</description>
        <time_frame>post operative 30 min in post anaesthesia care unit</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group A</title>
            <description>No intervention was done ,served as a control group.</description>
          </group>
          <group group_id="O2">
            <title>Group B</title>
            <description>Intervention:peristaltic pneumatic compression device was placed on the legs of the patient and was active. HUNTLEIGH FLOWTRON ACS900 calf length device was used.&#xD;
HUNTLEIGH FLOWTRON ACS900</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Blood Pressure at T6</title>
          <description>Mean blood pressure measurement at T6</description>
          <units>millimeters of mercury</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86.71" spread="8.98"/>
                    <measurement group_id="O2" value="92.54" spread="8.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.011</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Femoral Vein Velocity at T0</title>
        <description>Femoral vein velocity measuement at T0</description>
        <time_frame>15 minutes pre induction</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group A</title>
            <description>No intervention was done ,served as a control group.</description>
          </group>
          <group group_id="O2">
            <title>Group B</title>
            <description>Intervention:peristaltic pneumatic compression device was placed on the legs of the patient and was active. HUNTLEIGH FLOWTRON ACS900 calf length device was used.&#xD;
HUNTLEIGH FLOWTRON ACS900</description>
          </group>
        </group_list>
        <measure>
          <title>Femoral Vein Velocity at T0</title>
          <description>Femoral vein velocity measuement at T0</description>
          <units>centimeters per second</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.35" spread="4.20"/>
                    <measurement group_id="O2" value="31.31" spread="7.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.207</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Femoral Vein Velocity at T2</title>
        <description>Femoral vein velocity measurement at T2</description>
        <time_frame>15 minutes after induction</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group A</title>
            <description>No intervention was done ,served as a control group.</description>
          </group>
          <group group_id="O2">
            <title>Group B</title>
            <description>Intervention:peristaltic pneumatic compression device was placed on the legs of the patient and was active. HUNTLEIGH FLOWTRON ACS900 calf length device was used.&#xD;
HUNTLEIGH FLOWTRON ACS900</description>
          </group>
        </group_list>
        <measure>
          <title>Femoral Vein Velocity at T2</title>
          <description>Femoral vein velocity measurement at T2</description>
          <units>centimeters per second</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.79" spread="4.02"/>
                    <measurement group_id="O2" value="33.61" spread="7.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.142</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Femoral Vein Velocity at T6</title>
        <description>Femoral vein velocity measurement at T6</description>
        <time_frame>after 30 minutes in post anaesthesia care unit</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group A</title>
            <description>No intervention was done ,served as a control group.</description>
          </group>
          <group group_id="O2">
            <title>Group B</title>
            <description>Intervention:peristaltic pneumatic compression device was placed on the legs of the patient and was active. HUNTLEIGH FLOWTRON ACS900 calf length device was used.&#xD;
HUNTLEIGH FLOWTRON ACS900</description>
          </group>
        </group_list>
        <measure>
          <title>Femoral Vein Velocity at T6</title>
          <description>Femoral vein velocity measurement at T6</description>
          <units>centimeters per second</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.35" spread="5.64"/>
                    <measurement group_id="O2" value="31.92" spread="5.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.021</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Femoral Vein Velocity Variance</title>
        <description>the variance in femoral vein velocity was calculated by subtracting the femoral vein velocity pre induction from femoral vein velocity 15 min after induction divided by mean of the two values in percentage</description>
        <time_frame>15 minutes pre induction to 30 minutes in post anaesthesia care unit</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group A</title>
            <description>No intervention was done ,served as a control group.</description>
          </group>
          <group group_id="O2">
            <title>Group B</title>
            <description>Intervention:peristaltic pneumatic compression device was placed on the legs of the patient and was active. HUNTLEIGH FLOWTRON ACS900 calf length device was used.&#xD;
HUNTLEIGH FLOWTRON ACS900</description>
          </group>
        </group_list>
        <measure>
          <title>Femoral Vein Velocity Variance</title>
          <description>the variance in femoral vein velocity was calculated by subtracting the femoral vein velocity pre induction from femoral vein velocity 15 min after induction divided by mean of the two values in percentage</description>
          <units>percentage of velocity</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.419" spread="8.444"/>
                    <measurement group_id="O2" value="7.188" spread="5.385"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0001</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Femoral Artery Velocity at T0</title>
        <description>Femoral artery velocity measurement at T0</description>
        <time_frame>15 minutes pre induction</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group A</title>
            <description>No intervention was done ,served as a control group.</description>
          </group>
          <group group_id="O2">
            <title>Group B</title>
            <description>Intervention:peristaltic pneumatic compression device was placed on the legs of the patient and was active. HUNTLEIGH FLOWTRON ACS900 calf length device was used.&#xD;
HUNTLEIGH FLOWTRON ACS900</description>
          </group>
        </group_list>
        <measure>
          <title>Femoral Artery Velocity at T0</title>
          <description>Femoral artery velocity measurement at T0</description>
          <units>centimeters per second</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69.15" spread="14.08"/>
                    <measurement group_id="O2" value="76.25" spread="13.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.030</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Femoral Artery Velocity at T2</title>
        <description>Femoral artery velocity measurement at T2</description>
        <time_frame>15 minutes after induction</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group A</title>
            <description>No intervention was done ,served as a control group.</description>
          </group>
          <group group_id="O2">
            <title>Group B</title>
            <description>Intervention:peristaltic pneumatic compression device was placed on the legs of the patient and was active. HUNTLEIGH FLOWTRON ACS900 calf length device was used.&#xD;
HUNTLEIGH FLOWTRON ACS900</description>
          </group>
        </group_list>
        <measure>
          <title>Femoral Artery Velocity at T2</title>
          <description>Femoral artery velocity measurement at T2</description>
          <units>centimeters per second</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67.74" spread="11.96"/>
                    <measurement group_id="O2" value="73.91" spread="11.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.048</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Femoral Artery Velocity at T6</title>
        <description>Femoral artery velocity measurement at T6</description>
        <time_frame>after 30 minutes in post anaesthesia care unit</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group A</title>
            <description>No intervention was done ,served as a control group.</description>
          </group>
          <group group_id="O2">
            <title>Group B</title>
            <description>Intervention:peristaltic pneumatic compression device was placed on the legs of the patient and was active. HUNTLEIGH FLOWTRON ACS900 calf length device was used.&#xD;
HUNTLEIGH FLOWTRON ACS900</description>
          </group>
        </group_list>
        <measure>
          <title>Femoral Artery Velocity at T6</title>
          <description>Femoral artery velocity measurement at T6</description>
          <units>centimeters per second</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69.82" spread="11.78"/>
                    <measurement group_id="O2" value="76.63" spread="14.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.047</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Inferior Venacava Diameter (Maximum) at T0</title>
        <description>inferior venacava diameter (maximum) meaurement at T0</description>
        <time_frame>15 min pre induction</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group A</title>
            <description>No intervention was done ,served as a control group.</description>
          </group>
          <group group_id="O2">
            <title>Group B</title>
            <description>Intervention:peristaltic pneumatic compression device was placed on the legs of the patient and was active. HUNTLEIGH FLOWTRON ACS900 calf length device was used.&#xD;
HUNTLEIGH FLOWTRON ACS900</description>
          </group>
        </group_list>
        <measure>
          <title>Inferior Venacava Diameter (Maximum) at T0</title>
          <description>inferior venacava diameter (maximum) meaurement at T0</description>
          <units>centimeters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.16" spread="0.14"/>
                    <measurement group_id="O2" value="1.26" spread="0.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.019</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Inferior Venacava Diameter (Maximum) at T2</title>
        <description>inferior venacava diameter (maximum) meaurement at T2</description>
        <time_frame>15 min after induction</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group A</title>
            <description>No intervention was done ,served as a control group.</description>
          </group>
          <group group_id="O2">
            <title>Group B</title>
            <description>Intervention:peristaltic pneumatic compression device was placed on the legs of the patient and was active. HUNTLEIGH FLOWTRON ACS900 calf length device was used.&#xD;
HUNTLEIGH FLOWTRON ACS900</description>
          </group>
        </group_list>
        <measure>
          <title>Inferior Venacava Diameter (Maximum) at T2</title>
          <description>inferior venacava diameter (maximum) meaurement at T2</description>
          <units>centimeters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.27" spread="0.11"/>
                    <measurement group_id="O2" value="1.27" spread="0.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.000</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Inferior Venacava Diameter (Maximum) at T6</title>
        <description>inferior venacava diameter (maximum) meaurement at T6</description>
        <time_frame>after 30 min in post anaesthesia care unit</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group A</title>
            <description>No intervention was done ,served as a control group.</description>
          </group>
          <group group_id="O2">
            <title>Group B</title>
            <description>Intervention:peristaltic pneumatic compression device was placed on the legs of the patient and was active. HUNTLEIGH FLOWTRON ACS900 calf length device was used.&#xD;
HUNTLEIGH FLOWTRON ACS900</description>
          </group>
        </group_list>
        <measure>
          <title>Inferior Venacava Diameter (Maximum) at T6</title>
          <description>inferior venacava diameter (maximum) meaurement at T6</description>
          <units>centimeters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.19" spread="0.13"/>
                    <measurement group_id="O2" value="1.31" spread="0.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.004</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Inferior Venacava Diameter (Minimum) at T0</title>
        <description>inferior venacava diameter (minimum) meaurement at T0</description>
        <time_frame>15 min pre induction</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group A</title>
            <description>No intervention was done ,served as a control group.</description>
          </group>
          <group group_id="O2">
            <title>Group B</title>
            <description>Intervention:peristaltic pneumatic compression device was placed on the legs of the patient and was active. HUNTLEIGH FLOWTRON ACS900 calf length device was used.&#xD;
HUNTLEIGH FLOWTRON ACS900</description>
          </group>
        </group_list>
        <measure>
          <title>Inferior Venacava Diameter (Minimum) at T0</title>
          <description>inferior venacava diameter (minimum) meaurement at T0</description>
          <units>centimeters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.06" spread="0.13"/>
                    <measurement group_id="O2" value="1.15" spread="0.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.020</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Inferior Venacava Diameter (Minimum) at T2</title>
        <description>inferior venacava diameter (minimum) meaurement at T2</description>
        <time_frame>15 min after induction</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group A</title>
            <description>No intervention was done ,served as a control group.</description>
          </group>
          <group group_id="O2">
            <title>Group B</title>
            <description>Intervention:peristaltic pneumatic compression device was placed on the legs of the patient and was active. HUNTLEIGH FLOWTRON ACS900 calf length device was used.&#xD;
HUNTLEIGH FLOWTRON ACS900</description>
          </group>
        </group_list>
        <measure>
          <title>Inferior Venacava Diameter (Minimum) at T2</title>
          <description>inferior venacava diameter (minimum) meaurement at T2</description>
          <units>centimeters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.02" spread="0.09"/>
                    <measurement group_id="O2" value="1.15" spread="0.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.000</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Inferior Venacava Diameter (Minimum) at T6</title>
        <description>inferior venacava diameter (minimum) meaurement at T6</description>
        <time_frame>after 30 min in post anaesthesia care unit</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group A</title>
            <description>No intervention was done ,served as a control group.</description>
          </group>
          <group group_id="O2">
            <title>Group B</title>
            <description>Intervention:peristaltic pneumatic compression device was placed on the legs of the patient and was active. HUNTLEIGH FLOWTRON ACS900 calf length device was used.&#xD;
HUNTLEIGH FLOWTRON ACS900</description>
          </group>
        </group_list>
        <measure>
          <title>Inferior Venacava Diameter (Minimum) at T6</title>
          <description>inferior venacava diameter (minimum) meaurement at T6</description>
          <units>centimeters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.11" spread="0.13"/>
                    <measurement group_id="O2" value="1.18" spread="0.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.053</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Inferior Venacava Diameter Collapsibility Index at T0</title>
        <description>the collapsibility index was calculated by dividing the difference of maximum inferior vena cava diameter and minimum inferior vena cava diameter by mean of the two diameters multiplied by 100.This was done for pre induction spontaneously breathing patients</description>
        <time_frame>15 min pre induction</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group A</title>
            <description>No intervention was done ,served as a control group.</description>
          </group>
          <group group_id="O2">
            <title>Group B</title>
            <description>Intervention:peristaltic pneumatic compression device was placed on the legs of the patient and was active. HUNTLEIGH FLOWTRON ACS900 calf length device was used.&#xD;
HUNTLEIGH FLOWTRON ACS900</description>
          </group>
        </group_list>
        <measure>
          <title>Inferior Venacava Diameter Collapsibility Index at T0</title>
          <description>the collapsibility index was calculated by dividing the difference of maximum inferior vena cava diameter and minimum inferior vena cava diameter by mean of the two diameters multiplied by 100.This was done for pre induction spontaneously breathing patients</description>
          <units>percentage of diameter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.06" spread="4.17"/>
                    <measurement group_id="O2" value="9.32" spread="1.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.746</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Inferior Venacava Diameter Distensibility Index at T2</title>
        <description>the inferior venacava distensibility index for post induction mechanically ventilated patients. It was calculated by dividing the difference of maximum inferior vena cava diameter and minimum inferior vena cava diameter by minimum inferior vena cava diameters multiplied by 100 .</description>
        <time_frame>15 min after induction</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group A</title>
            <description>No intervention was done ,served as a control group.</description>
          </group>
          <group group_id="O2">
            <title>Group B</title>
            <description>Intervention:peristaltic pneumatic compression device was placed on the legs of the patient and was active. HUNTLEIGH FLOWTRON ACS900 calf length device was used.&#xD;
HUNTLEIGH FLOWTRON ACS900</description>
          </group>
        </group_list>
        <measure>
          <title>Inferior Venacava Diameter Distensibility Index at T2</title>
          <description>the inferior venacava distensibility index for post induction mechanically ventilated patients. It was calculated by dividing the difference of maximum inferior vena cava diameter and minimum inferior vena cava diameter by minimum inferior vena cava diameters multiplied by 100 .</description>
          <units>percentage of diameter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.05" spread="4.17"/>
                    <measurement group_id="O2" value="8.39" spread="2.841"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.006</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Inferior Venacava Diameter Collapsibility Index at T6</title>
        <description>the collapsibility index was calculated by dividing the difference of maximum inferior vena cava diameter and minimum inferior vena cava diameter by mean of the two diameters multiplied by 100.This was done for pre induction spontaneously breathing patients</description>
        <time_frame>after 30 minutes in post anaesthesia care unit</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group A</title>
            <description>No intervention was done ,served as a control group.</description>
          </group>
          <group group_id="O2">
            <title>Group B</title>
            <description>Intervention:peristaltic pneumatic compression device was placed on the legs of the patient and was active. HUNTLEIGH FLOWTRON ACS900 calf length device was used.&#xD;
HUNTLEIGH FLOWTRON ACS900</description>
          </group>
        </group_list>
        <measure>
          <title>Inferior Venacava Diameter Collapsibility Index at T6</title>
          <description>the collapsibility index was calculated by dividing the difference of maximum inferior vena cava diameter and minimum inferior vena cava diameter by mean of the two diameters multiplied by 100.This was done for pre induction spontaneously breathing patients</description>
          <units>percentage of diameter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.04" spread="3.46"/>
                    <measurement group_id="O2" value="10.03" spread="4.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.003</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>FLUID REQUIREMENT (Cumulative)</title>
        <description>fluid requirement (cumulative) during the operative period.</description>
        <time_frame>operative period</time_frame>
        <population>the population is same as the assigned population.</population>
        <group_list>
          <group group_id="O1">
            <title>Group A</title>
            <description>No intervention was done ,served as a control group.</description>
          </group>
          <group group_id="O2">
            <title>Group B</title>
            <description>Intervention:peristaltic pneumatic compression device was placed on the legs of the patient and was active. HUNTLEIGH FLOWTRON ACS900 calf length device was used.&#xD;
HUNTLEIGH FLOWTRON ACS900</description>
          </group>
        </group_list>
        <measure>
          <title>FLUID REQUIREMENT (Cumulative)</title>
          <description>fluid requirement (cumulative) during the operative period.</description>
          <population>the population is same as the assigned population.</population>
          <units>milliliters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1456.67" spread="307.87"/>
                    <measurement group_id="O2" value="1291.66" spread="320.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.043</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Blood Loss During Operation</title>
        <description>Total blood loss during operation</description>
        <time_frame>During operating procedure</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group A</title>
            <description>No intervention was done ,served as a control group.</description>
          </group>
          <group group_id="O2">
            <title>Group B</title>
            <description>Intervention:peristaltic pneumatic compression device was placed on the legs of the patient and was active. HUNTLEIGH FLOWTRON ACS900 calf length device was used.&#xD;
HUNTLEIGH FLOWTRON ACS900</description>
          </group>
        </group_list>
        <measure>
          <title>Blood Loss During Operation</title>
          <description>Total blood loss during operation</description>
          <units>milliliters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.67" spread="50.34"/>
                    <measurement group_id="O2" value="116.67" spread="41.80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.160</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Pre induction to post anaesthesia care unit.</time_frame>
      <desc>No serious adverse events were reported. No mortality by all cause is reported. No risk for other(not including serious) adverse events is reported.</desc>
      <group_list>
        <group group_id="E1">
          <title>Group 1</title>
          <description>In Group 1 - The PPC was placed on operating table, next to patients calves during the procedure.</description>
        </group>
        <group group_id="E2">
          <title>Group 2</title>
          <description>In Group 2 - The PPC was placed over calves and inflated during induction of General Anaesthesia and maintenance.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Outcome of the patients was not studied.&#xD;
The patients studied underwent procedures for short duration of 2-3 hours. Longer procedures were not taken into consideration and the applicability and efficacy in those procedures was not evaluated.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr M KESARI</name_or_title>
      <organization>ALL INDIA INSTITUTE OF MEDICAL SCIENCES,RISHIKESH,UTTARAKHAND,INDIA.</organization>
      <phone>7093005219</phone>
      <email>kesyellow@yahoo.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03789474
org study id: AIIMSRishikesh
nct id: NCT03789474
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
Impact of intraoperative use of pneumatic peristaltic compression device on hemodynamics vis
      a vis on fluid requirement during general anaesthesia and surgery.
Induction of general anaesthesia is associated with cardiac depression and peripheral
      vasodilatation resulting in hypotension .This hypotension can be corrected by giving
      intravenous fluid, or the vasoconstrictor. While optimum fluid balances in the perioperative
      period is of vital importance in overnight fasting patients to correct the fluid deficit, any
      fluid overload is not only counterproductive to the heart function but is associated with
      fluid retention in body and edema in postoperative period.

      Peristaltic pneumatic compression device, a variant of intermittent sequential compression of
      legs, uses higher pressure and longer compression cycles to avoid venous stasis in
      immobilized patients. Sequential compression devices have sleeves with pockets of inflation,
      which works to squeeze on the appendage in a milking action .The most distal areas will
      inflate initially, and the subsequent pockets will follow in the same manner. The primary aim
      of the device is to squeeze blood from the underlying deep veins to proximal side. When the
      inflatable sleeves deflate, the veins will replenish with blood. The intermittent
      compressions of the sleeves will ensure the movement of venous blood . Peristaltic Pneumatic
      Compression of the legs significantly reduces fluid demand and enhances stability during
      minor ear, nose, and throat surgery. Peristaltic Pneumatic Compression has the potential to
      support fluid restriction regimens during surgery .
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: About 60 patients of age group 25 to 50 belonging to American Society of Anesthesiologists (ASA) grade 1 and 2 were allocated to either control or sequential pneumatic compression device group .Allocation was done by sealed envelop technique.In the operating room,in the control group,the device was placed on operating table and was placed next to the patients calves.in the intervention group,the device was placed over calves and inflated during induction of General Anaesthesia (GA) and maintenance.legs were draped in both the groups.Femoral vein velocities were assessed using ultrasound in preoperative period , intraoperatively 15 minutes after induction of anaesthesia and in post-operative period.
primary purpose: Prevention
masking: Triple (Participant, Care Provider, Investigator)
masking description: Draping of the legs was done in both the groups.the care observer nor investigator were blinded for the allocation.
measure: Heart Rate at T0
time frame: 15 minutes pre induction
description: heart rate monitoring at T0
measure: Heart Rate at T1
time frame: post induction heart rate
description: heart rate monitoring at T1
measure: Heart Rate at T2
time frame: 15 minutes after induction
description: heart rate monitoring at T2
measure: Heart Rate at T3
time frame: 30 minutes after induction
description: heart rate monitoring at T3
measure: Heart Rate at T4
time frame: 60 minutes after induction
description: heart rate monitoring at T4
measure: Heart Rate at T5
time frame: 120 minutes after induction
description: heart rate monitoring at T5
measure: Heart Rate at T6
time frame: post operative period after 30 min in post anaesthesia care unit
description: heart rate monitoring at T6
measure: Systolic Blood Pressure at T0
time frame: 15 min before induction
description: systolic blood pressure measurement at T0
measure: Systolic Blood Pressure at T1
time frame: post induction
description: systolic blood pressure measurement at T1
measure: Systolic Blood Pressure at T2
time frame: 15 min after induction
description: systolic blood pressure measurement at T2
measure: Systolic Blood Pressure at T3
time frame: 30 min after induction
description: systolic blood pressure measurement at T3
measure: Systolic Blood Pressure at T4
time frame: 60 min after induction
description: systolic blood pressure measurement at T4
measure: Systolic Blood Pressure at T5
time frame: 120 min after induction
description: systolic blood pressure measurement at T5
measure: Systolic Blood Pressure at T6
time frame: post operative period 30 min in post asnaesthesia care unit
description: systolic blood pressure measurement at T6
measure: Diastolic Blood Presure at T0
time frame: 15 minutes before induction
description: Diastolic blood pressure measurement at T0
measure: Diastolic Blood Pressure at T1
time frame: immediately after induction
description: Diastolic blood pressure measurement at T1
measure: Diastolic Blood Pressure at T2
time frame: 15 minutes after induction
description: Diastolic blood pressure measurement at T2
measure: Diastolic Blood Pressure at T3
time frame: 30 minutes after induction
description: Diastolic blood pressure measurement at T3
measure: Diastolic Blood Pressure at T4
time frame: 60 minutes after induction
description: Diastolic blood pressure measurement at T4
measure: Diastolic Blood Pressure at T5
time frame: 120 minutes after induction
description: Diastolic blood pressure measurement at T5
measure: Diastolic Blood Pressure at T6
time frame: post induction 30 min in post anaesthesia care unit
description: Diastolic blood pressure measurement at T6
measure: Mean Blood Pressure at T0
time frame: 15 minutes pre induction
description: Mean blood pressure measurement at T0
measure: Mean Blood Pressure at T1
time frame: immediately after induction
description: Mean blood pressure measurement at T1
measure: Mean Blood Pressure at T2
time frame: 15 minutes after induction
description: Mean blood pressure measurement at T2
measure: Mean Blood Pressure at T3
time frame: 30 minutes after induction
description: Mean blood pressure measurement at T3
measure: Mean Blood Pressure at T4
time frame: 60 minutes after induction
description: Mean blood pressure measurement at T4
measure: Mean Blood Pressure at T5
time frame: 120 minutes after induction
description: Mean blood pressure measurement at T5
measure: Mean Blood Pressure at T6
time frame: post operative 30 min in post anaesthesia care unit
description: Mean blood pressure measurement at T6
measure: Femoral Vein Velocity at T0
time frame: 15 minutes pre induction
description: Femoral vein velocity measuement at T0
measure: Femoral Vein Velocity at T2
time frame: 15 minutes after induction
description: Femoral vein velocity measurement at T2
measure: Femoral Vein Velocity at T6
time frame: after 30 minutes in post anaesthesia care unit
description: Femoral vein velocity measurement at T6
measure: Femoral Vein Velocity Variance
time frame: 15 minutes pre induction to 30 minutes in post anaesthesia care unit
description: the variance in femoral vein velocity was calculated by subtracting the femoral vein velocity pre induction from femoral vein velocity 15 min after induction divided by mean of the two values in percentage
measure: Femoral Artery Velocity at T0
time frame: 15 minutes pre induction
description: Femoral artery velocity measurement at T0
measure: Femoral Artery Velocity at T2
time frame: 15 minutes after induction
description: Femoral artery velocity measurement at T2
measure: Femoral Artery Velocity at T6
time frame: after 30 minutes in post anaesthesia care unit
description: Femoral artery velocity measurement at T6
measure: Inferior Venacava Diameter (Maximum) at T0
time frame: 15 min pre induction
description: inferior venacava diameter (maximum) meaurement at T0
measure: Inferior Venacava Diameter (Maximum) at T2
time frame: 15 min after induction
description: inferior venacava diameter (maximum) meaurement at T2
measure: Inferior Venacava Diameter (Maximum) at T6
time frame: after 30 min in post anaesthesia care unit
description: inferior venacava diameter (maximum) meaurement at T6
measure: Inferior Venacava Diameter (Minimum) at T0
time frame: 15 min pre induction
description: inferior venacava diameter (minimum) meaurement at T0
measure: Inferior Venacava Diameter (Minimum) at T2
time frame: 15 min after induction
description: inferior venacava diameter (minimum) meaurement at T2
measure: Inferior Venacava Diameter (Minimum) at T6
time frame: after 30 min in post anaesthesia care unit
description: inferior venacava diameter (minimum) meaurement at T6
measure: Inferior Venacava Diameter Collapsibility Index at T0
time frame: 15 min pre induction
description: the collapsibility index was calculated by dividing the difference of maximum inferior vena cava diameter and minimum inferior vena cava diameter by mean of the two diameters multiplied by 100.This was done for pre induction spontaneously breathing patients
measure: Inferior Venacava Diameter Distensibility Index at T2
time frame: 15 min after induction
description: the inferior venacava distensibility index for post induction mechanically ventilated patients. It was calculated by dividing the difference of maximum inferior vena cava diameter and minimum inferior vena cava diameter by minimum inferior vena cava diameters multiplied by 100 .
measure: Inferior Venacava Diameter Collapsibility Index at T6
time frame: after 30 minutes in post anaesthesia care unit
description: the collapsibility index was calculated by dividing the difference of maximum inferior vena cava diameter and minimum inferior vena cava diameter by mean of the two diameters multiplied by 100.This was done for pre induction spontaneously breathing patients
measure: FLUID REQUIREMENT (Cumulative)
time frame: operative period
description: fluid requirement (cumulative) during the operative period.
measure: Blood Loss During Operation
time frame: During operating procedure
description: Total blood loss during operation
arm group label: Group A
arm group type: No Intervention
description: No intervention was done ,served as a control group.
arm group label: Group B
arm group type: Experimental
description: Intervention:peristaltic pneumatic compression device was placed on the legs of the patient and was active. HUNTLEIGH FLOWTRON ACS900 calf length device was used.
intervention type: Device
intervention name: HUNTLEIGH FLOWTRON ACS900
arm group label: Group B
criteria: 
gender: All
minimum age: 25 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mukesh Tripathi, MD
role: Principal Investigator
affiliation: All India Institute of Medical Sciences, Rishikesh
citation: Kiefer N, Theis J, Putensen-Himmer G, Hoeft A, Zenker S. Peristaltic pneumatic compression of the legs reduces fluid demand and improves hemodynamic stability during surgery: a randomized, prospective study. Anesthesiology. 2011 Mar;114(3):536-44. doi: 10.1097/ALN.0b013e31820c3973.
PMID: 21307764
citation: Kaufmann KB, Stein L, Bogatyreva L, Ulbrich F, Kaifi JT, Hauschke D, Loop T, Goebel U. Oesophageal Doppler guided goal-directed haemodynamic therapy in thoracic surgery - a single centre randomized parallel-arm trial. Br J Anaesth. 2017 Jun 1;118(6):852-861. doi: 10.1093/bja/aew447.
PMID: 28575331
citation: Meng L, Heerdt PM. Perioperative goal-directed haemodynamic therapy based on flow parameters: a concept in evolution. Br J Anaesth. 2016 Dec;117(suppl 3):iii3-iii17. doi: 10.1093/bja/aew363.
PMID: 27940452
citation: Millard JA, Hill BB, Cook PS, Fenoglio ME, Stahlgren LH. Intermittent sequential pneumatic compression in prevention of venous stasis associated with pneumoperitoneum during laparoscopic cholecystectomy. Arch Surg. 1993 Aug;128(8):914-8; discussion 918-9. doi: 10.1001/archsurg.1993.01420200088016.
PMID: 8343064
responsible party type: Principal Investigator
investigator affiliation: All India Institute of Medical Sciences, Rishikesh
investigator full name: Dr. Masaipeta Kesari
investigator title: Junior resident,Principal Investigator,Department of Anaesthesiology, All India institute of Medical Sciences, Rishikesh.
sharing ipd: Yes
ipd description: study protocol,stastical analysis plan,informed consent form.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: june 2020 till june 2021
ipd access criteria: after obtaining consent.
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Outcome of the patients was not studied.
The patients studied underwent procedures for short duration of 2-3 hours. Longer procedures were not taken into consideration and the applicability and efficacy in those procedures was not evaluated.
point of contact: 