Hypobaria and Traumatic Pneumothorax

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01670942
Recruitment Status : Completed
First Posted : August 23, 2012
Last Update Posted : April 28, 2014
Information provided by (Responsible Party):
Sarah Majercik, Intermountain Health Care, Inc.

Brief Summary:

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).

Condition or disease Intervention/treatment
Pneumothorax Other: hypobaric chamber

Detailed Description:
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.

Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effects of Hypobaric Conditions on Small, Traumatic Pneumothoraces
Study Start Date : October 2012
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Collapsed Lung

Group/Cohort Intervention/treatment
Traumatic Pneumothorax1
hypobaric chamber
Other: hypobaric chamber
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.

Primary Outcome Measures :
  1. Change in pneumothorax size [ Time Frame: baseline and 2 hours ]
    Will document pneumothorax size before simulated altitude, and size after being at simulated altitude for two hours

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with unilateral pneumothorax of traumatic etiology that has been treated with oxygen, observation, or tube thoracostomy

Inclusion Criteria:

  1. Inpatient status on trauma surgery service
  2. An established diagnosis of pneumothorax with a traumatic etiology (patients with iatrogenic pneumothorax from attempted central venous line placement will be considered to have a traumatic etiology)
  3. Age ≥ 18 at the time of injury

Exclusion Criteria:

  1. Pregnancy
  2. Unable to give informed consent
  3. Pneumothorax which does not satisfactorily resolve after treatment with tube thoracostomy and requires operative intervention such as video assisted thoracoscopic surgery (VATS) or thoracotomy
  4. Pneumothorax requiring tube thoracostomy where the tube has been removed for < 4 or > 48 hours
  5. Head injury with GCS < 15 at time of evaluation for study
  6. Other injuries or conditions which would preclude participant's ability to remain in chamber for two hours
  7. NYHA class III or IV heart failure, active coronary artery disease, arrhythmias, pacemakers, implantable cardiac defibrillator, pulmonary hypertension, claustrophobia
  8. Severe obstructive or restrictive lung disease
  9. Chronic hypoxemia requiring supplemental oxygen
  10. Hypoxemia for any reason (pulmonary contusion, atelectasis, pneumonia, etc.) requiring > 3 liters supplemental oxygen at the time of entry into the study
  11. Inability to tolerate the confines of the chamber

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01670942

United States, Utah
Intermountain Medical Center
Murray, Utah, United States, 84157
Sponsors and Collaborators
Intermountain Health Care, Inc.
Principal Investigator: Sarah Majercik, MD, MBA Intermountain Health Care, Inc.
Study Director: Lindell Weaver, MD Intermountain Health Care, Inc.

Responsible Party: Sarah Majercik, MD, MBA, FACS, Intermountain Health Care, Inc. Identifier: NCT01670942     History of Changes
Other Study ID Numbers: IRB#1024157
First Posted: August 23, 2012    Key Record Dates
Last Update Posted: April 28, 2014
Last Verified: April 2014

Keywords provided by Sarah Majercik, Intermountain Health Care, Inc.:
commercial air travel

Additional relevant MeSH terms:
Pleural Diseases
Respiratory Tract Diseases