<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/NCT01670942</url>
  </required_header>
  <id_info>
    <org_study_id>IRB#1024157</org_study_id>
    <nct_id>NCT01670942</nct_id>
  </id_info>
  <brief_title>Hypobaria and Traumatic Pneumothorax</brief_title>
  <official_title>The Effects of Hypobaric Conditions on Small, Traumatic Pneumothoraces</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Intermountain Health Care, Inc.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Intermountain Health Care, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this research is to see if people who have had a collapsed lung that has been&#xD;
      re-expanded can be safely taken to an elevation that a person might experience while in a&#xD;
      commercial airplane without having their lung partially collapse again, or have any symptoms&#xD;
      such as feeling short of breath or having oxygen levels in the blood decrease while at the&#xD;
      simulated altitude.&#xD;
&#xD;
      The investigators hypothesize that subjects who have had a collapsed lung that has been&#xD;
      re-expanded will not have any adverse symptoms or signs while subjected to a simulated&#xD;
      altitude of 8400 feet (565mm Hg) or 12650 ft (471mm Hg).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators will study patients who have been diagnosed with a unilateral traumatic&#xD;
      pneumothorax that has been treated. Treatment for pneumothorax may consist of high-flow&#xD;
      oxygen therapy in the case of very small or &quot;occult&quot; pneumothorax, or tube thoracostomy&#xD;
      (&quot;chest tube&quot;) in the case of larger pneumothorax. Treatment for pneumothorax will be at the&#xD;
      discretion of the attending trauma surgeon. Once the pneumothorax has radiographically&#xD;
      resolved, the chest tube, if used, has been removed, and prior to discharge from the&#xD;
      hospital, subjects will undergo a two hour stay in a hypobaric chamber. In the first phase of&#xD;
      the study, they will undergo a two hour stay in a hypobaric chamber at a barometric pressure&#xD;
      of 565mm Hg, simulating the change in pressure from Salt Lake City to a cruising airliner. If&#xD;
      subjects in the first phase do not suffer any adverse events, the investigators will proceed&#xD;
      with the second phase. In the second phase of the study, subjects will undergo a two hour&#xD;
      stay in the hypobaric chamber at a barometric pressure of 471mm Hg, simulating the change in&#xD;
      pressure from sea level to a cruising airliner. Prior to the hypobaric exposure, and at the&#xD;
      conclusion of the two hours under hypobaric conditions, single view chest radiographs will be&#xD;
      performed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">December 2013</completion_date>
  <primary_completion_date type="Actual">December 2013</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>Change in pneumothorax size</measure>
    <time_frame>baseline and 2 hours</time_frame>
    <description>Will document pneumothorax size before simulated altitude, and size after being at simulated altitude for two hours</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">20</enrollment>
  <condition>Pneumothorax</condition>
  <arm_group>
    <arm_group_label>Traumatic Pneumothorax1</arm_group_label>
    <description>hypobaric chamber</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>hypobaric chamber</intervention_name>
    <description>We will use a large (26 tons) multi-place hyperbaric and hypobaric chamber at IMC in Murray, Utah (elevation 1500m or 4500ft, average ambient barometric pressure 645mm Hg). In the hypobaric study, the barometric pressure will be lowered to 554mm Hg (phase 1) or 471mm Hg (phase 2) over 20 minutes and held there for two hours.</description>
    <arm_group_label>Traumatic Pneumothorax1</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with unilateral pneumothorax of traumatic etiology that has been treated with&#xD;
        oxygen, observation, or tube thoracostomy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Inpatient status on trauma surgery service&#xD;
&#xD;
          2. An established diagnosis of pneumothorax with a traumatic etiology (patients with&#xD;
             iatrogenic pneumothorax from attempted central venous line placement will be&#xD;
             considered to have a traumatic etiology)&#xD;
&#xD;
          3. Age ≥ 18 at the time of injury&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnancy&#xD;
&#xD;
          2. Unable to give informed consent&#xD;
&#xD;
          3. Pneumothorax which does not satisfactorily resolve after treatment with tube&#xD;
             thoracostomy and requires operative intervention such as video assisted thoracoscopic&#xD;
             surgery (VATS) or thoracotomy&#xD;
&#xD;
          4. Pneumothorax requiring tube thoracostomy where the tube has been removed for &lt; 4 or &gt;&#xD;
             48 hours&#xD;
&#xD;
          5. Head injury with GCS &lt; 15 at time of evaluation for study&#xD;
&#xD;
          6. Other injuries or conditions which would preclude participant's ability to remain in&#xD;
             chamber for two hours&#xD;
&#xD;
          7. NYHA class III or IV heart failure, active coronary artery disease, arrhythmias,&#xD;
             pacemakers, implantable cardiac defibrillator, pulmonary hypertension, claustrophobia&#xD;
&#xD;
          8. Severe obstructive or restrictive lung disease&#xD;
&#xD;
          9. Chronic hypoxemia requiring supplemental oxygen&#xD;
&#xD;
         10. Hypoxemia for any reason (pulmonary contusion, atelectasis, pneumonia, etc.) requiring&#xD;
             &gt; 3 liters supplemental oxygen at the time of entry into the study&#xD;
&#xD;
         11. Inability to tolerate the confines of the chamber&#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>Sarah Majercik, MD, MBA</last_name>
    <role>Principal Investigator</role>
    <affiliation>Intermountain Health Care, Inc.</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Lindell Weaver, MD</last_name>
    <role>Study Director</role>
    <affiliation>Intermountain Health Care, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Intermountain Medical Center</name>
      <address>
        <city>Murray</city>
        <state>Utah</state>
        <zip>84157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2014</verification_date>
  <study_first_submitted>August 18, 2012</study_first_submitted>
  <study_first_submitted_qc>August 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 23, 2012</study_first_posted>
  <last_update_submitted>April 25, 2014</last_update_submitted>
  <last_update_submitted_qc>April 25, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 28, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Intermountain Health Care, Inc.</investigator_affiliation>
    <investigator_full_name>Sarah Majercik</investigator_full_name>
    <investigator_title>MD, MBA, FACS</investigator_title>
  </responsible_party>
  <keyword>pneumothorax</keyword>
  <keyword>trauma</keyword>
  <keyword>commercial air travel</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pneumothorax</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/NCT01670942
org study id: IRB#1024157
nct id: NCT01670942
lead sponsor: 
has dmc: No
The purpose of this research is to see if people who have had a collapsed lung that has been
      re-expanded can be safely taken to an elevation that a person might experience while in a
      commercial airplane without having their lung partially collapse again, or have any symptoms
      such as feeling short of breath or having oxygen levels in the blood decrease while at the
      simulated altitude.

      The investigators hypothesize that subjects who have had a collapsed lung that has been
      re-expanded will not have any adverse symptoms or signs while subjected to a simulated
      altitude of 8400 feet (565mm Hg) or 12650 ft (471mm Hg).
The investigators will study patients who have been diagnosed with a unilateral traumatic
      pneumothorax that has been treated. Treatment for pneumothorax may consist of high-flow
      oxygen therapy in the case of very small or "occult" pneumothorax, or tube thoracostomy
      ("chest tube") in the case of larger pneumothorax. Treatment for pneumothorax will be at the
      discretion of the attending trauma surgeon. Once the pneumothorax has radiographically
      resolved, the chest tube, if used, has been removed, and prior to discharge from the
      hospital, subjects will undergo a two hour stay in a hypobaric chamber. In the first phase of
      the study, they will undergo a two hour stay in a hypobaric chamber at a barometric pressure
      of 565mm Hg, simulating the change in pressure from Salt Lake City to a cruising airliner. If
      subjects in the first phase do not suffer any adverse events, the investigators will proceed
      with the second phase. In the second phase of the study, subjects will undergo a two hour
      stay in the hypobaric chamber at a barometric pressure of 471mm Hg, simulating the change in
      pressure from sea level to a cruising airliner. Prior to the hypobaric exposure, and at the
      conclusion of the two hours under hypobaric conditions, single view chest radiographs will be
      performed.
observational model: Cohort
time perspective: Prospective
measure: Change in pneumothorax size
time frame: baseline and 2 hours
description: Will document pneumothorax size before simulated altitude, and size after being at simulated altitude for two hours
arm group label: Traumatic Pneumothorax1
description: hypobaric chamber
intervention type: Other
intervention name: hypobaric chamber
description: We will use a large (26 tons) multi-place hyperbaric and hypobaric chamber at IMC in Murray, Utah (elevation 1500m or 4500ft, average ambient barometric pressure 645mm Hg). In the hypobaric study, the barometric pressure will be lowered to 554mm Hg (phase 1) or 471mm Hg (phase 2) over 20 minutes and held there for two hours.
arm group label: Traumatic Pneumothorax1
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sarah Majercik, MD, MBA
role: Principal Investigator
affiliation: Intermountain Health Care, Inc.
last name: Lindell Weaver, MD
role: Study Director
affiliation: Intermountain Health Care, Inc.
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Intermountain Health Care, Inc.
investigator full name: Sarah Majercik
investigator title: MD, MBA, FACS
mesh term: Pneumothorax