<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/NCT01705119</url>
  </required_header>
  <id_info>
    <org_study_id>12-1773</org_study_id>
    <nct_id>NCT01705119</nct_id>
  </id_info>
  <brief_title>The Effects of Vertical Position on Gas Exchange in Patients With Respiratory Failure</brief_title>
  <official_title>The Effects of Vertical Position on Gas Exchange in Patients With Respiratory Failure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Chicago</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Chicago</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate how changing from a supine to upright position&#xD;
      affects gas exchange for patients with hypoxemic respiratory failure.&#xD;
&#xD;
      The research question is: will oxygen saturation and/or partial pressure of oxygen in the&#xD;
      blood change when a patient with hypoxemic respiratory failure moves from a supine to upright&#xD;
      position?&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Our hypothesis is that blood oxygen tension will not decrease and may even increase when a&#xD;
      patient with respiratory failure stands up. Supine positioning often causes partial lung&#xD;
      collapse, which results in a decreased amount of lung being available for gas exchange. In&#xD;
      patients with Acute Respiratory Distress Syndrome (ARDS), tilting the patient up in bed has&#xD;
      been shown to increase oxygen tension and improve lung compliance. Positional changes are&#xD;
      sometimes used as a &quot;rescue&quot; intervention in patients with severe hypoxemia from ARDS. The&#xD;
      investigators hope to conclude that severe hypoxemia should not be viewed as a&#xD;
      contraindication to physical therapy, but rather physical therapy may be a potential&#xD;
      intervention for patients with marginal gas exchange.&#xD;
&#xD;
      After sedative interruption, physical therapists and nursing staff will assist mechanically&#xD;
      ventilated patients in moving to the side of the bed. They will assess the extremity strength&#xD;
      using the MRC scale. If lower extremity strength is at least 4/5, the patient will be&#xD;
      assisted to assume the upright position. The investigators will monitor the patient&#xD;
      continuously and the session will be stopped at any point for&#xD;
&#xD;
      A. Mean arterial pressure &lt;65 B. Heart rate &lt;40, &gt;130 beats/min C. Respiratory rate &lt;5, &gt;40&#xD;
      breaths/ min D. Pulse oximetry &lt;88% E. Marked ventilator dyssynchrony F. Patient distress G.&#xD;
      New arrhythmia H. Concern for myocardial ischemia I. Concern for airway device integrity J.&#xD;
      Endotracheal tube removal&#xD;
&#xD;
      At this point, the patient's vital signs, pulse oximetry, and measures of lung compliance&#xD;
      will be obtained. If an arterial line is in place and there have been ventilator adjustments&#xD;
      since the morning arterial blood gas, the investigators will draw an arterial blood gas.&#xD;
&#xD;
      The physical therapists and nursing staff will then help the patient stand up. After one&#xD;
      minute, the investigators will record another set of vital signs, pulse oximetry, and&#xD;
      measures of lung compliance from the mechanical ventilator. If an arterial line is in place,&#xD;
      the investigators will draw another arterial blood gas.&#xD;
&#xD;
      The patient will then be assisted back into bed. One hour later, the investigators will&#xD;
      record the patient's vital signs, pulse oximetry, and measures of lung compliance from the&#xD;
      mechanical ventilator.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">October 1, 2012</start_date>
  <completion_date type="Anticipated">December 2024</completion_date>
  <primary_completion_date type="Actual">June 10, 2021</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>PaO2 to FiO2 ratio</measure>
    <time_frame>change from baseline to 1 hr</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Oxygen Saturation</measure>
    <time_frame>change from baseline to 1 hr</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in blood PCO2</measure>
    <time_frame>change from baseline to 1 hr</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in blood pH</measure>
    <time_frame>change from baseline to 1hr</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Tidal Volume</measure>
    <time_frame>change from baseline to 1 hr</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Vital Signs</measure>
    <time_frame>change from baseline to 1hr</time_frame>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Respiratory Failure</condition>
  <arm_group>
    <arm_group_label>Mechanically Ventilated</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standing</intervention_name>
    <arm_group_label>Mechanically Ventilated</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients aged ≥18 years who are mechanically ventilated&#xD;
&#xD;
          -  An oxygen saturation of 88-94% or an arterial line&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Mean arterial pressure &lt;65&#xD;
&#xD;
          -  Heart rate &lt; 40 or &gt; 130 beats/min&#xD;
&#xD;
          -  Respiratory rate &lt; 5 or &gt; 40 breaths/min&#xD;
&#xD;
          -  Pulse oximetry &lt; 88%&#xD;
&#xD;
          -  Evidence of elevated intracranial pressure&#xD;
&#xD;
          -  Active gastrointestinal blood loss&#xD;
&#xD;
          -  Active myocardial ischemia&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Actively undergoing a procedure&#xD;
&#xD;
          -  Patient agitation requiring increased sedative administration in the last 30 mins&#xD;
&#xD;
          -  Insecure airway (device)&#xD;
&#xD;
          -  The patient was not ambulatory prior to hospitalization&#xD;
&#xD;
          -  The patient's body habitus and/or mental status make it unsafe to stand up&#xD;
&#xD;
          -  The patient has been placed on strict bed rest by the treating physicians&#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>John P Kress, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Chicago</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Chicago Medical Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>October 8, 2012</study_first_submitted>
  <study_first_submitted_qc>October 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 12, 2012</study_first_posted>
  <last_update_submitted>May 11, 2023</last_update_submitted>
  <last_update_submitted_qc>May 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Mechanically Ventilated</keyword>
  <keyword>Critical Care</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Insufficiency</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/NCT01705119
org study id: 12-1773
nct id: NCT01705119
lead sponsor: 
has dmc: Yes
The purpose of this study is to investigate how changing from a supine to upright position
      affects gas exchange for patients with hypoxemic respiratory failure.

      The research question is: will oxygen saturation and/or partial pressure of oxygen in the
      blood change when a patient with hypoxemic respiratory failure moves from a supine to upright
      position?
Our hypothesis is that blood oxygen tension will not decrease and may even increase when a
      patient with respiratory failure stands up. Supine positioning often causes partial lung
      collapse, which results in a decreased amount of lung being available for gas exchange. In
      patients with Acute Respiratory Distress Syndrome (ARDS), tilting the patient up in bed has
      been shown to increase oxygen tension and improve lung compliance. Positional changes are
      sometimes used as a "rescue" intervention in patients with severe hypoxemia from ARDS. The
      investigators hope to conclude that severe hypoxemia should not be viewed as a
      contraindication to physical therapy, but rather physical therapy may be a potential
      intervention for patients with marginal gas exchange.

      After sedative interruption, physical therapists and nursing staff will assist mechanically
      ventilated patients in moving to the side of the bed. They will assess the extremity strength
      using the MRC scale. If lower extremity strength is at least 4/5, the patient will be
      assisted to assume the upright position. The investigators will monitor the patient
      continuously and the session will be stopped at any point for

      A. Mean arterial pressure <65 B. Heart rate <40, >130 beats/min C. Respiratory rate <5, >40
      breaths/ min D. Pulse oximetry <88% E. Marked ventilator dyssynchrony F. Patient distress G.
      New arrhythmia H. Concern for myocardial ischemia I. Concern for airway device integrity J.
      Endotracheal tube removal

      At this point, the patient's vital signs, pulse oximetry, and measures of lung compliance
      will be obtained. If an arterial line is in place and there have been ventilator adjustments
      since the morning arterial blood gas, the investigators will draw an arterial blood gas.

      The physical therapists and nursing staff will then help the patient stand up. After one
      minute, the investigators will record another set of vital signs, pulse oximetry, and
      measures of lung compliance from the mechanical ventilator. If an arterial line is in place,
      the investigators will draw another arterial blood gas.

      The patient will then be assisted back into bed. One hour later, the investigators will
      record the patient's vital signs, pulse oximetry, and measures of lung compliance from the
      mechanical ventilator.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: PaO2 to FiO2 ratio
time frame: change from baseline to 1 hr
measure: Oxygen Saturation
time frame: change from baseline to 1 hr
measure: change in blood PCO2
time frame: change from baseline to 1 hr
measure: Change in blood pH
time frame: change from baseline to 1hr
measure: Tidal Volume
time frame: change from baseline to 1 hr
measure: Vital Signs
time frame: change from baseline to 1hr
arm group label: Mechanically Ventilated
arm group type: Experimental
intervention type: Other
intervention name: Standing
arm group label: Mechanically Ventilated
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: John P Kress, MD
role: Principal Investigator
affiliation: University of Chicago
facility: 
country: United States
responsible party type: Sponsor
mesh term: Respiratory Insufficiency