Trial record 6 of 30 for:    Open Studies | "Pneumothorax"

Hypobaria and Traumatic Pneumothorax

This study is currently recruiting participants.
Verified September 2013 by Intermountain Health Care, Inc.
Sponsor:
Information provided by (Responsible Party):
Sarah Majercik, Intermountain Health Care, Inc.
ClinicalTrials.gov Identifier:
NCT01670942
First received: August 18, 2012
Last updated: September 24, 2013
Last verified: September 2013
  Purpose

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 Intervention
Pneumothorax
Other: hypobaric chamber

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effects of Hypobaric Conditions on Small, Traumatic Pneumothoraces

Resource links provided by NLM:


Further study details as provided by Intermountain Health Care, Inc.:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 20
Study Start Date: October 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01670942

Contacts
Contact: Sarah Majercik, MD, MBA 314-288-8957 sarah.majercik@imail.org
Contact: Lindell Weaver, MD Lindell.weaver@imail.org

Locations
United States, Utah
Intermountain Medical Center Recruiting
Murray, Utah, United States, 84157
Contact: Lindell Weaver, MD       Lindell.weaver@imail.org   
Principal Investigator: Sarah Majercik, MD, MBA         
Sub-Investigator: Lindell Weaver, MD         
Sub-Investigator: Thomas W White, MD         
Sub-Investigator: Steven Granger, MD         
Sub-Investigator: Don VanBoerum, MD         
Sub-Investigator: William Beninati, MD         
Sub-Investigator: Joseph Bledsoe, MD         
Sponsors and Collaborators
Intermountain Health Care, Inc.
Investigators
Principal Investigator: Sarah Majercik, MD, MBA Intermountain Health Care, Inc.
Study Director: Lindell Weaver, MD Intermountain Health Care, Inc.
  More Information

No publications provided

Responsible Party: Sarah Majercik, MD, MBA, FACS, Intermountain Health Care, Inc.
ClinicalTrials.gov Identifier: NCT01670942     History of Changes
Other Study ID Numbers: IRB#1024157
Study First Received: August 18, 2012
Last Updated: September 24, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Intermountain Health Care, Inc.:
pneumothorax
trauma
commercial air travel

Additional relevant MeSH terms:
Pneumothorax
Pleural Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 22, 2014