xml: <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/NCT06020768</url>
    </required_header>
    <id_info>
      <org_study_id>2022-3/28</org_study_id>
      <nct_id>NCT06020768</nct_id>
    </id_info>
    <brief_title>The Effect of Different Bed-Head Angles on the Haemodynamic Parameters of Intensive Care Patients Lying in the Supine Position</brief_title>
    <official_title>The Effect of Different Bed-Head Angles on the Haemodynamic Parameters of Intensive Care Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Uludag University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Uludag University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Aim: The aim of this study was to examine the effect of different bed-head angles given to&#xD;
        patients lying in the supine position in an intensive care unit on the haemodynamic&#xD;
        parameters of central venous pressure, systolic and diastolic blood pressure, heart rate,&#xD;
        breathing rate and peripheral oxygen saturation.&#xD;
  &#xD;
        Methods: The study was conducted with 50 intensive care patients aged 18 and over in a&#xD;
        general surgery intensive care unit in Turkey. With each patient in the supine position, the&#xD;
        bed-head was raised to an angle of 0, 20, 30 and 45 degrees without a pillow, and the&#xD;
        haemodynamic parameters of central venous pressure, systolic and diastolic blood pressure,&#xD;
        heart rate, breathing rate and peripheral oxygen saturation were recorded after 0 and 10&#xD;
        minutes.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Aim: The aim of this study was to examine the effect of different bed-head angles given to&#xD;
        patients lying in the supine position in an intensive care unit on the haemodynamic&#xD;
        parameters of central venous pressure, systolic and diastolic blood pressure, heart rate,&#xD;
        breathing rate and peripheral oxygen saturation.&#xD;
  &#xD;
        Design: This was a non-randomised quasi-experimental repeated measures study. Settings: The&#xD;
        study was conducted with 50 intensive care patients aged 18 and over in a general surgery&#xD;
        intensive care unit in Turkey.&#xD;
  &#xD;
        Methods: With each patient in the supine position, the bed-head was raised to an angle of 0,&#xD;
        20, 30 and 45 degrees without a pillow, and the haemodynamic parameters of central venous&#xD;
        pressure, systolic and diastolic blood pressure, heart rate, breathing rate and peripheral&#xD;
        oxygen saturation were recorded after 0 and 10 minutes. The data obtained was evaluated using&#xD;
        the Mann-Whitney test, the Kruskal Wallis test and the Bonferroni test.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">March 1, 2022</start_date>
    <completion_date type="Actual">September 10, 2022</completion_date>
    <primary_completion_date type="Actual">July 23, 2022</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>central venous pressure</measure>
      <time_frame>4 months</time_frame>
      <description>central venous pressure in mmHg</description>
    </primary_outcome>
    <primary_outcome>
      <measure>blood pressure</measure>
      <time_frame>4 months</time_frame>
      <description>blood pressure pressure in mmHg</description>
    </primary_outcome>
    <primary_outcome>
      <measure>heart rate</measure>
      <time_frame>4 months</time_frame>
      <description>heart rate in beats</description>
    </primary_outcome>
    <primary_outcome>
      <measure>breathing rate</measure>
      <time_frame>4 months</time_frame>
      <description>breathing rate in breaths</description>
    </primary_outcome>
    <primary_outcome>
      <measure>peripheral oxygen saturation</measure>
      <time_frame>4 months</time_frame>
      <description>peripheral oxygen saturation in %</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>weight</measure>
      <time_frame>4 months</time_frame>
      <description>weight in kilograms</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>height</measure>
      <time_frame>4 months</time_frame>
      <description>height in meters</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>BMI</measure>
      <time_frame>4 months</time_frame>
      <description>BMI in kg/m^2</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Actual">50</enrollment>
    <condition>Thyroidectomy</condition>
    <condition>Colon Surgery</condition>
    <condition>Cholecystectomy</condition>
    <condition>Inguinal Hernia</condition>
    <arm_group>
      <arm_group_label>the different bed-head angles in the supine position</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The researcher brought the patient to the supine position with the bed-head at 0 degree, and immediately (minute 0) made haemodynamic measurements: central venous pressure, systolic and diastolic blood pressure, heart rate, breathing rate and peripheral oxygen saturation. It was taken into account that this could change haemodynamic parameters, and immediately after a 10-minute period of rest, the same haemodynamic measurements were repeated. After this, the bed-head was adjusted to an angle of 20 degree, and the same procedure was repeated, with measurements after 0 and 10 minutes. The same procedure was followed with the bed-head raised to 30 degree and then to 45 degree. In positioning the patients' bed-heads to different angles, a spirit level and a protractor were used.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>the bed-head was raised to an angle of 0, 20, 30 and 45 degrees</intervention_name>
      <description>With each patient in the supine position, the bed-head was raised to an angle of 0, 20, 30 and 45 degrees without a pillow, and the haemodynamic parameters of central venous pressure, systolic and diastolic blood pressure, heart rate, breathing rate and peripheral oxygen saturation were recorded after 0 and 10 minutes.</description>
      <arm_group_label>the different bed-head angles in the supine position</arm_group_label>
      <other_name>haemodynamic parameters were recorded</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  participating voluntarily in the study&#xD;
  &#xD;
            -  being aged over 18 years,&#xD;
  &#xD;
            -  having stayed in the General Surgery Intensive Care Unit for at least 24 hours,&#xD;
  &#xD;
            -  being monitored for 24 hours,&#xD;
  &#xD;
            -  having a central venous catheter inserted,&#xD;
  &#xD;
            -  having central venous pressure measured.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  being less than 18 years of age,&#xD;
  &#xD;
            -  not wanting to participate in the study, or during the course of the research, wishing&#xD;
               to withdraw from the study,&#xD;
  &#xD;
            -  receiving sedation treatment,&#xD;
  &#xD;
            -  receiving haemodialysis treatment,&#xD;
  &#xD;
            -  having an oxygen saturation value of less than 90%,&#xD;
  &#xD;
            -  being unable to tolerate a 0° prone position (hypovolemic or bradycardic).&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Bursa Uludag University Hospital</name>
        <address>
          <city>Bursa</city>
          <state>Nilüfer</state>
          <zip>16059</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 26, 2023</study_first_submitted>
    <study_first_submitted_qc>August 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 1, 2023</study_first_posted>
    <last_update_submitted>August 26, 2023</last_update_submitted>
    <last_update_submitted_qc>August 26, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Uludag University</investigator_affiliation>
      <investigator_full_name>Dilek Yilmaz, PhD</investigator_full_name>
      <investigator_title>Associate Professor</investigator_title>
    </responsible_party>
    <keyword>Intensive care units</keyword>
    <keyword>haemodynamic parameters</keyword>
    <keyword>central venous pressure</keyword>
    <keyword>supine position</keyword>
    <keyword>bed-head angle</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hernia, Inguinal</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06020768
  org study id: 2022-3/28
  nct id: NCT06020768
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Aim: The aim of this study was to examine the effect of different bed-head angles given to
        patients lying in the supine position in an intensive care unit on the haemodynamic
        parameters of central venous pressure, systolic and diastolic blood pressure, heart rate,
        breathing rate and peripheral oxygen saturation.
  
        Methods: The study was conducted with 50 intensive care patients aged 18 and over in a
        general surgery intensive care unit in Turkey. With each patient in the supine position, the
        bed-head was raised to an angle of 0, 20, 30 and 45 degrees without a pillow, and the
        haemodynamic parameters of central venous pressure, systolic and diastolic blood pressure,
        heart rate, breathing rate and peripheral oxygen saturation were recorded after 0 and 10
        minutes.
  Aim: The aim of this study was to examine the effect of different bed-head angles given to
        patients lying in the supine position in an intensive care unit on the haemodynamic
        parameters of central venous pressure, systolic and diastolic blood pressure, heart rate,
        breathing rate and peripheral oxygen saturation.
  
        Design: This was a non-randomised quasi-experimental repeated measures study. Settings: The
        study was conducted with 50 intensive care patients aged 18 and over in a general surgery
        intensive care unit in Turkey.
  
        Methods: With each patient in the supine position, the bed-head was raised to an angle of 0,
        20, 30 and 45 degrees without a pillow, and the haemodynamic parameters of central venous
        pressure, systolic and diastolic blood pressure, heart rate, breathing rate and peripheral
        oxygen saturation were recorded after 0 and 10 minutes. The data obtained was evaluated using
        the Mann-Whitney test, the Kruskal Wallis test and the Bonferroni test.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: central venous pressure
  time frame: 4 months
  description: central venous pressure in mmHg
  measure: blood pressure
  time frame: 4 months
  description: blood pressure pressure in mmHg
  measure: heart rate
  time frame: 4 months
  description: heart rate in beats
  measure: breathing rate
  time frame: 4 months
  description: breathing rate in breaths
  measure: peripheral oxygen saturation
  time frame: 4 months
  description: peripheral oxygen saturation in %
  measure: weight
  time frame: 4 months
  description: weight in kilograms
  measure: height
  time frame: 4 months
  description: height in meters
  measure: BMI
  time frame: 4 months
  description: BMI in kg/m^2
  arm group label: the different bed-head angles in the supine position
  arm group type: Experimental
  description: The researcher brought the patient to the supine position with the bed-head at 0 degree, and immediately (minute 0) made haemodynamic measurements: central venous pressure, systolic and diastolic blood pressure, heart rate, breathing rate and peripheral oxygen saturation. It was taken into account that this could change haemodynamic parameters, and immediately after a 10-minute period of rest, the same haemodynamic measurements were repeated. After this, the bed-head was adjusted to an angle of 20 degree, and the same procedure was repeated, with measurements after 0 and 10 minutes. The same procedure was followed with the bed-head raised to 30 degree and then to 45 degree. In positioning the patients' bed-heads to different angles, a spirit level and a protractor were used.
  intervention type: Other
  intervention name: the bed-head was raised to an angle of 0, 20, 30 and 45 degrees
  description: With each patient in the supine position, the bed-head was raised to an angle of 0, 20, 30 and 45 degrees without a pillow, and the haemodynamic parameters of central venous pressure, systolic and diastolic blood pressure, heart rate, breathing rate and peripheral oxygen saturation were recorded after 0 and 10 minutes.
  arm group label: the different bed-head angles in the supine position
  other name: haemodynamic parameters were recorded
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Uludag University
  investigator full name: Dilek Yilmaz, PhD
  investigator title: Associate Professor
  mesh term: Hernia, Inguinal
  sharing ipd: Undecided