Trials / Completed
CompletedNCT01670942
Hypobaria and Traumatic Pneumothorax
The Effects of Hypobaric Conditions on Small, Traumatic Pneumothoraces
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 20 (actual)
- Sponsor
- Intermountain Health Care, Inc. · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2012-10-01
- Primary completion
- 2013-12-01
- Completion
- 2013-12-01
- First posted
- 2012-08-23
- Last updated
- 2014-04-28
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01670942. Inclusion in this directory is not an endorsement.