Hypobaria and Traumatic Pneumothorax
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).
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||The Effects of Hypobaric Conditions on Small, Traumatic Pneumothoraces|
- Change in pneumothorax size [ Time Frame: baseline and 2 hours ] [ Designated as safety issue: No ]Will document pneumothorax size before simulated altitude, and size after being at simulated altitude for two hours
|Study Start Date:||October 2012|
|Study Completion Date:||December 2013|
|Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01670942
|United States, Utah|
|Intermountain Medical Center|
|Murray, Utah, United States, 84157|
|Principal Investigator:||Sarah Majercik, MD, MBA||Intermountain Health Care, Inc.|
|Study Director:||Lindell Weaver, MD||Intermountain Health Care, Inc.|