<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/NCT03013062</url>
  </required_header>
  <id_info>
    <org_study_id>INT/IEC/2016/2641</org_study_id>
    <nct_id>NCT03013062</nct_id>
  </id_info>
  <brief_title>Relation Between Mean Pulmonary Artery Pressure and Pulmonary Acceleration Time and Comparison With Previous Formulae</brief_title>
  <official_title>Derivation of New Formula Relating Pulmonary Acceleration Time and Mean Pulmonary Artery Pressure in Indian Population and Comparison With Previous Formulas</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Postgraduate Institute of Medical Education and Research</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Postgraduate Institute of Medical Education and Research</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Since the pulmonary artery hypertension is defined based on MPAP and the two previous&#xD;
      formulae relating MPAP and PAT were derived in western population, the investigator planned&#xD;
      to conduct a prospective study to derive a new formula for measuring MPAP from PAT in Indian&#xD;
      population and compare the accuracy of all the three formulae&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After obtaining ethics committee approval and informed patient consent, minimum 25 patients &gt;&#xD;
      18 years of age who are undergoing cardiac surgery with the invasive monitoring of pulmonary&#xD;
      artery pressure will be enrolled in this study.The demographics and the preoperative&#xD;
      echocardiographic measurement will be noted. In the operating room, once the intravenous&#xD;
      access is obtained, central venous catheterisation and pulmonary artery catheterisation will&#xD;
      be done as per the institutional protocol. Once the Transthoracic echocardiogram (TTE) is&#xD;
      performed patient will be induced with opioids, intravenous or inhalational agents, and&#xD;
      muscle relaxant according to the patient clinical and hemodynamic condition. Once the patient&#xD;
      airway is secured with tracheal tube, transesophageal echocardiogram (TEE) will be performed&#xD;
      before and after bypass, which is routine in all patients undergoing cardiac surgery in the&#xD;
      institution. Echocardiographic images will be analysed by two separate echocardiographers to&#xD;
      detect inter-individual variability. Patient blood pressure and heart rate will be maintained&#xD;
      within 20% of their baseline value throughout surgery. Based on the patient condition at the&#xD;
      end of surgery, extubation will be done in the operating room or in intensive care unit (ICU)&#xD;
      after a period of elective ventilation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">June 2017</completion_date>
  <primary_completion_date type="Anticipated">June 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Pulmonary acceleration time</measure>
    <time_frame>Till post-extubation, an average of 2 days</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Pulmonary Hypertension</condition>
  <arm_group>
    <arm_group_label>WITH PULMONARY HYPERTENSION</arm_group_label>
    <description>It is defined as MPAP &gt; 25 mm Hg at rest or &gt;30 mm Hg during exercise with PVR &gt; 3 wood units and PCWP &lt; 15 mm Hg.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        &gt; 18 years of age who are undergoing cardiac surgery with the invasive monitoring of&#xD;
        pulmonary artery pressure&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years of age who are undergoing cardiac surgery with the invasive monitoring of&#xD;
             pulmonary artery pressure&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with known right ventricular outflow tract obstruction, intra-cardiac shunt&#xD;
             lesions will be excluded&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>GANESH KUMAR M</last_name>
    <role>Principal Investigator</role>
    <affiliation>PGIMER, CHANDIGARH</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>GANESH KUMAR M, MD</last_name>
    <phone>8968170779</phone>
    <email>mganeshkumar19@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>PGIMER</name>
      <address>
        <city>Chandigarh</city>
        <zip>160012</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>GANESH KUMAR M, MD</last_name>
      <phone>8968170779</phone>
      <email>mganeshkumar19@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>June 2017</verification_date>
  <study_first_submitted>January 2, 2017</study_first_submitted>
  <study_first_submitted_qc>January 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 6, 2017</study_first_posted>
  <last_update_submitted>June 1, 2017</last_update_submitted>
  <last_update_submitted_qc>June 1, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">June 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Postgraduate Institute of Medical Education and Research</investigator_affiliation>
    <investigator_full_name>Ganesh Kumar Munirathinam</investigator_full_name>
    <investigator_title>Fellow resident, Department of anesthesia and intensive care, Principal investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension, Pulmonary</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03013062
org study id: INT/IEC/2016/2641
nct id: NCT03013062
lead sponsor: 
has dmc: No
Since the pulmonary artery hypertension is defined based on MPAP and the two previous
      formulae relating MPAP and PAT were derived in western population, the investigator planned
      to conduct a prospective study to derive a new formula for measuring MPAP from PAT in Indian
      population and compare the accuracy of all the three formulae
After obtaining ethics committee approval and informed patient consent, minimum 25 patients >
      18 years of age who are undergoing cardiac surgery with the invasive monitoring of pulmonary
      artery pressure will be enrolled in this study.The demographics and the preoperative
      echocardiographic measurement will be noted. In the operating room, once the intravenous
      access is obtained, central venous catheterisation and pulmonary artery catheterisation will
      be done as per the institutional protocol. Once the Transthoracic echocardiogram (TTE) is
      performed patient will be induced with opioids, intravenous or inhalational agents, and
      muscle relaxant according to the patient clinical and hemodynamic condition. Once the patient
      airway is secured with tracheal tube, transesophageal echocardiogram (TEE) will be performed
      before and after bypass, which is routine in all patients undergoing cardiac surgery in the
      institution. Echocardiographic images will be analysed by two separate echocardiographers to
      detect inter-individual variability. Patient blood pressure and heart rate will be maintained
      within 20% of their baseline value throughout surgery. Based on the patient condition at the
      end of surgery, extubation will be done in the operating room or in intensive care unit (ICU)
      after a period of elective ventilation.
observational model: Cohort
time perspective: Prospective
measure: Pulmonary acceleration time
time frame: Till post-extubation, an average of 2 days
arm group label: WITH PULMONARY HYPERTENSION
description: It is defined as MPAP > 25 mm Hg at rest or >30 mm Hg during exercise with PVR > 3 wood units and PCWP < 15 mm Hg.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: GANESH KUMAR M
role: Principal Investigator
affiliation: PGIMER, CHANDIGARH
last name: GANESH KUMAR M, MD
phone: 8968170779
email: mganeshkumar19@gmail.com
facility: 
status: Recruiting
contact: 
country: India
responsible party type: Principal Investigator
investigator affiliation: Postgraduate Institute of Medical Education and Research
investigator full name: Ganesh Kumar Munirathinam
investigator title: Fellow resident, Department of anesthesia and intensive care, Principal investigator
mesh term: Hypertension, Pulmonary