Hypobaria and Traumatic Pneumothorax

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sarah Majercik, Intermountain Health Care, Inc.
ClinicalTrials.gov Identifier:
NCT01670942
First received: August 18, 2012
Last updated: April 25, 2014
Last verified: April 2014

August 18, 2012
April 25, 2014
October 2012
December 2013   (final data collection date for primary outcome measure)
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
Not Provided
Complete list of historical versions of study NCT01670942 on ClinicalTrials.gov Archive Site
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Hypobaria and Traumatic Pneumothorax
The Effects of Hypobaric Conditions on Small, Traumatic Pneumothoraces

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
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Patients with unilateral pneumothorax of traumatic etiology that has been treated with oxygen, observation, or tube thoracostomy

Pneumothorax
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.
Traumatic Pneumothorax1
hypobaric chamber
Intervention: Other: hypobaric chamber
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
December 2013
December 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01670942
IRB#1024157
No
Sarah Majercik, Intermountain Health Care, Inc.
Intermountain Health Care, Inc.
Not Provided
Principal Investigator: Sarah Majercik, MD, MBA Intermountain Health Care, Inc.
Study Director: Lindell Weaver, MD Intermountain Health Care, Inc.
Intermountain Health Care, Inc.
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP