<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/NCT01668875</url>
  </required_header>
  <id_info>
    <org_study_id>KKU-AMS-PT</org_study_id>
    <nct_id>NCT01668875</nct_id>
  </id_info>
  <brief_title>Hemodynamic and Ventilatory Responses to Head-down Postural Drainage Position</brief_title>
  <official_title>Acute Hemodynamic and Ventilatory Responses to Head-down 30° Postural Drainage Position in Critically Traumatic Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Khon Kaen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Khon Kaen University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to explore acute hemodynamic and ventilatory responses to&#xD;
      head-down 30 degree postural drainage position in patients with blunt chest and/or abdominal&#xD;
      injury in the traumatic intensive care unit.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study Protocol The study protocol consisted of 2 conditions: treatment condition (A) and sham&#xD;
      condition (B). The order of the conditions was randomly assigned to either the treatment or&#xD;
      sham for the first round and vise versa in the second round in a balanced cross-over design&#xD;
      (A-B-B-A) so there were four sets of measurements per patient.&#xD;
&#xD;
      For the treatment condition (A), the study consists of three consecutive periods 1) baseline&#xD;
      period: 10 minutes rest in horizontal supine lying 2) intervention period: 10 minutes rest in&#xD;
      head-down 30 degree supine lying 3) recovery period: return to horizontal supine lying and&#xD;
      rest for 10 minutes . For the Sham condition (B), the study was performed with a similar&#xD;
      procedure except the intervention period consisted of horizontal supine lying.&#xD;
&#xD;
      Hemodynamic and ventilatory parameter were recorded at the start of each period (0 min) and&#xD;
      every 2 minute until end of each period for both conditions. Hemodynamic and ventilatory&#xD;
      dependent variables were heart rate (HR), systolic blood pressure (SBP), diastolic blood&#xD;
      pressure (DBP), mean arterial pressure (MAP), electrocardiography (ECG), central venous&#xD;
      pressure (CVP), respiratory rate (RR), oxygen saturation (SpO2), tidal volume (VT), minute&#xD;
      ventilation (VE), dynamic lung compliance (Cdyn) and end-tidal expiratory pressure of CO2&#xD;
      (PETCO2). Subjects were rested between each condition. Subjects were suctioned via&#xD;
      endotracheal tube to clear airway at 10 minutes before study commencement of either A-B or&#xD;
      B-A.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">October 2012</completion_date>
  <primary_completion_date type="Actual">October 2012</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>Crossover Assignment</intervention_model>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change of heart rate (HR) from baseline.</measure>
    <time_frame>measured every 2 minutes during each phase</time_frame>
    <description>Heart rate (HR) was recorded 3 times every 2 minute in each phase, each phase will have 10 minutes and each condition will have 3 phases (baseline, intervention, and recovery).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of systolic blood pressure (SBP) from baseline.</measure>
    <time_frame>measured every 2 minutes during each phase</time_frame>
    <description>Systolic blood pressure (SBP) was recorded 3 times every 2 minute in each phase, each phase will have 10 minutes and each condition will have 3 phases (baseline, intervention, and recovery).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of diastolic blood pressure (DBP) from baseline.</measure>
    <time_frame>measured every 2 minutes during each phase</time_frame>
    <description>Diastolic blood pressure (DBP) was recorded 3 times every 2 minute in each phase, each phase will have 10 minutes and each condition will have 3 phases (baseline, intervention, and recovery).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of mean arterial pressure (MAP) from baseline.</measure>
    <time_frame>measured every 2 minutes during each phase</time_frame>
    <description>Mean arterial pressure (MAP) was recorded 3 times every 2 minute in each phase, each phase will have 10 minutes and each condition will have 3 phases (baseline, intervention, and recovery).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of central venous pressure (CVP) from baseline.</measure>
    <time_frame>measures every 2 minutes in each phase</time_frame>
    <description>central venous pressure (CVP) was recorded 3 times every 2 minute in each phase, each phase will have 10 minutes and each condition will have 3 phases (baseline, intervention, and recovery).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of respiratory rate (RR) from baseline.</measure>
    <time_frame>measures every 2 minutes in each phase</time_frame>
    <description>respiratory rate (RR) was recorded 3 times every 2 minute in each phase, each phase will have 10 minutes and each condition will have 3 phases (baseline, intervention, and recovery).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of tidal volume (VT) from baseline</measure>
    <time_frame>measured every 2 minutes during each phase</time_frame>
    <description>tidal volume (VT) was recorded 3 times every 2 minute in each phase, each phase will have 10 minutes and each condition will have 3 phases (baseline, intervention, and recovery).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of minute ventilation (VE) from baseline</measure>
    <time_frame>measured every 2 minutes during each phase</time_frame>
    <description>minute ventilation (VE) was recorded 3 times every 2 minute in each phase, each phase will have 10 minutes and each condition will have 3 phases (baseline, intervention, and recovery).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of dynamic lung compliance (Cdyn) from baseline.</measure>
    <time_frame>measured every 2 minutes during each phase</time_frame>
    <description>dynamic lung compliance (Cdyn) was recorded 3 times every 2 minute in each phase, each phase will have 10 minutes and each condition will have 3 phases (baseline, intervention, and recovery).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of end-tidal expiratory pressure of carbon dioxide (PETCO2) from baseline</measure>
    <time_frame>measured every 2 minutes during each phase</time_frame>
    <description>end-tidal expiratory pressure of carbon dioxide (PETCO2) was recorded 3 times every 2 minute in each phase, each phase will have 10 minutes and each condition will have 3 phases (baseline, intervention, and recovery).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of oxygen saturation (SpO2) from baseline</measure>
    <time_frame>measured every 2 minutes during each phase</time_frame>
    <description>oxygen saturation (SpO2) was recorded 3 times every 2 minute in each phase, each phase will have 10 minutes and each condition will have 3 phases (baseline, intervention, and recovery).</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">11</enrollment>
  <condition>Traumatic Blunt Chest and/or Blunt Abdominal Injury</condition>
  <arm_group>
    <arm_group_label>Treatment condition</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In intervention period patients were received head-down 30 degree postural drainage position for 10 min.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham condition</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In intervention period patients were received horizontal supine lying for 10 min.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Head down 30 degree postural drainage position</intervention_name>
    <description>supine head down 30 degree on tilt table (intervention period in the treatment condition)</description>
    <arm_group_label>Treatment condition</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Horizontal supine lying</intervention_name>
    <description>horizontal supine lying on tilt table (intervention period in the sham condition)</description>
    <arm_group_label>Sham condition</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Mechanical ventilator dependence&#xD;
&#xD;
          -  Stable cardiopulmonary function at rest (HR 60-100 beats/min, systolic BP 90-140 mmHg&#xD;
             and diastolic BP 60-90 mmHg and SpO2&gt;95%. RR 10-20 breath/min&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Spine disorders such as spine fracture, HNP, spondylolisthesis, whiplash syndrome,&#xD;
             stenosis and spondylosis&#xD;
&#xD;
          -  Fracture of upper and/or lower limbs&#xD;
&#xD;
          -  Underlying acute or chronic cardiopulmonary diseases&#xD;
&#xD;
          -  Craniotomy or craniectomy&#xD;
&#xD;
          -  Unstable intracranial pressure, ICP&gt;12 cmH2O&#xD;
&#xD;
          -  Uncontrolled pain&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mr.Kantharakorn Hongrattana, master</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Physical Therapy, Khon Kaen Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Khon Kaen Hospital</name>
      <address>
        <city>Khon Kaen</city>
        <zip>40000</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>June 25, 2012</study_first_submitted>
  <study_first_submitted_qc>August 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2012</study_first_posted>
  <last_update_submitted>November 17, 2012</last_update_submitted>
  <last_update_submitted_qc>November 17, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 20, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Khon Kaen University</investigator_affiliation>
    <investigator_full_name>Kantharakorn Hongrattana</investigator_full_name>
    <investigator_title>Principal vinvestigator</investigator_title>
  </responsible_party>
  <keyword>head down postural drainage</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Abdominal Injuries</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/NCT01668875
org study id: KKU-AMS-PT
nct id: NCT01668875
lead sponsor: 
has dmc: Yes
The purpose of this study is to explore acute hemodynamic and ventilatory responses to
      head-down 30 degree postural drainage position in patients with blunt chest and/or abdominal
      injury in the traumatic intensive care unit.
Study Protocol The study protocol consisted of 2 conditions: treatment condition (A) and sham
      condition (B). The order of the conditions was randomly assigned to either the treatment or
      sham for the first round and vise versa in the second round in a balanced cross-over design
      (A-B-B-A) so there were four sets of measurements per patient.

      For the treatment condition (A), the study consists of three consecutive periods 1) baseline
      period: 10 minutes rest in horizontal supine lying 2) intervention period: 10 minutes rest in
      head-down 30 degree supine lying 3) recovery period: return to horizontal supine lying and
      rest for 10 minutes . For the Sham condition (B), the study was performed with a similar
      procedure except the intervention period consisted of horizontal supine lying.

      Hemodynamic and ventilatory parameter were recorded at the start of each period (0 min) and
      every 2 minute until end of each period for both conditions. Hemodynamic and ventilatory
      dependent variables were heart rate (HR), systolic blood pressure (SBP), diastolic blood
      pressure (DBP), mean arterial pressure (MAP), electrocardiography (ECG), central venous
      pressure (CVP), respiratory rate (RR), oxygen saturation (SpO2), tidal volume (VT), minute
      ventilation (VE), dynamic lung compliance (Cdyn) and end-tidal expiratory pressure of CO2
      (PETCO2). Subjects were rested between each condition. Subjects were suctioned via
      endotracheal tube to clear airway at 10 minutes before study commencement of either A-B or
      B-A.
allocation: Randomized
intervention model: Crossover Assignment
masking: None (Open Label)
measure: Change of heart rate (HR) from baseline.
time frame: measured every 2 minutes during each phase
description: Heart rate (HR) was recorded 3 times every 2 minute in each phase, each phase will have 10 minutes and each condition will have 3 phases (baseline, intervention, and recovery).
measure: Change of systolic blood pressure (SBP) from baseline.
time frame: measured every 2 minutes during each phase
description: Systolic blood pressure (SBP) was recorded 3 times every 2 minute in each phase, each phase will have 10 minutes and each condition will have 3 phases (baseline, intervention, and recovery).
measure: Change of diastolic blood pressure (DBP) from baseline.
time frame: measured every 2 minutes during each phase
description: Diastolic blood pressure (DBP) was recorded 3 times every 2 minute in each phase, each phase will have 10 minutes and each condition will have 3 phases (baseline, intervention, and recovery).
measure: Change of mean arterial pressure (MAP) from baseline.
time frame: measured every 2 minutes during each phase
description: Mean arterial pressure (MAP) was recorded 3 times every 2 minute in each phase, each phase will have 10 minutes and each condition will have 3 phases (baseline, intervention, and recovery).
measure: Change of central venous pressure (CVP) from baseline.
time frame: measures every 2 minutes in each phase
description: central venous pressure (CVP) was recorded 3 times every 2 minute in each phase, each phase will have 10 minutes and each condition will have 3 phases (baseline, intervention, and recovery).
measure: Change of respiratory rate (RR) from baseline.
time frame: measures every 2 minutes in each phase
description: respiratory rate (RR) was recorded 3 times every 2 minute in each phase, each phase will have 10 minutes and each condition will have 3 phases (baseline, intervention, and recovery).
measure: Change of tidal volume (VT) from baseline
time frame: measured every 2 minutes during each phase
description: tidal volume (VT) was recorded 3 times every 2 minute in each phase, each phase will have 10 minutes and each condition will have 3 phases (baseline, intervention, and recovery).
measure: Change of minute ventilation (VE) from baseline
time frame: measured every 2 minutes during each phase
description: minute ventilation (VE) was recorded 3 times every 2 minute in each phase, each phase will have 10 minutes and each condition will have 3 phases (baseline, intervention, and recovery).
measure: Change of dynamic lung compliance (Cdyn) from baseline.
time frame: measured every 2 minutes during each phase
description: dynamic lung compliance (Cdyn) was recorded 3 times every 2 minute in each phase, each phase will have 10 minutes and each condition will have 3 phases (baseline, intervention, and recovery).
measure: Change of end-tidal expiratory pressure of carbon dioxide (PETCO2) from baseline
time frame: measured every 2 minutes during each phase
description: end-tidal expiratory pressure of carbon dioxide (PETCO2) was recorded 3 times every 2 minute in each phase, each phase will have 10 minutes and each condition will have 3 phases (baseline, intervention, and recovery).
measure: Change of oxygen saturation (SpO2) from baseline
time frame: measured every 2 minutes during each phase
description: oxygen saturation (SpO2) was recorded 3 times every 2 minute in each phase, each phase will have 10 minutes and each condition will have 3 phases (baseline, intervention, and recovery).
arm group label: Treatment condition
arm group type: Experimental
description: In intervention period patients were received head-down 30 degree postural drainage position for 10 min.
arm group label: Sham condition
arm group type: Experimental
description: In intervention period patients were received horizontal supine lying for 10 min.
intervention type: Other
intervention name: Head down 30 degree postural drainage position
description: supine head down 30 degree on tilt table (intervention period in the treatment condition)
arm group label: Treatment condition
intervention type: Other
intervention name: Horizontal supine lying
description: horizontal supine lying on tilt table (intervention period in the sham condition)
arm group label: Sham condition
criteria: 
gender: All
minimum age: 15 Years
maximum age: 50 Years
healthy volunteers: No
last name: Mr.Kantharakorn Hongrattana, master
role: Principal Investigator
affiliation: Department of Physical Therapy, Khon Kaen Hospital
facility: 
country: Thailand
responsible party type: Principal Investigator
investigator affiliation: Khon Kaen University
investigator full name: Kantharakorn Hongrattana
investigator title: Principal vinvestigator
mesh term: Abdominal Injuries