- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01670942
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).
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Utah
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Murray, Utah, United States, 84157
- Intermountain Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Inpatient status on trauma surgery service
- 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)
- Age ≥ 18 at the time of injury
Exclusion Criteria:
- Pregnancy
- Unable to give informed consent
- Pneumothorax which does not satisfactorily resolve after treatment with tube thoracostomy and requires operative intervention such as video assisted thoracoscopic surgery (VATS) or thoracotomy
- Pneumothorax requiring tube thoracostomy where the tube has been removed for < 4 or > 48 hours
- Head injury with GCS < 15 at time of evaluation for study
- Other injuries or conditions which would preclude participant's ability to remain in chamber for two hours
- NYHA class III or IV heart failure, active coronary artery disease, arrhythmias, pacemakers, implantable cardiac defibrillator, pulmonary hypertension, claustrophobia
- Severe obstructive or restrictive lung disease
- Chronic hypoxemia requiring supplemental oxygen
- Hypoxemia for any reason (pulmonary contusion, atelectasis, pneumonia, etc.) requiring > 3 liters supplemental oxygen at the time of entry into the study
- Inability to tolerate the confines of the chamber
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Traumatic Pneumothorax1
hypobaric chamber
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in pneumothorax size
Time Frame: baseline and 2 hours
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Will document pneumothorax size before simulated altitude, and size after being at simulated altitude for two hours
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baseline and 2 hours
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sarah Majercik, MD, MBA, Intermountain Health Care, Inc.
- Study Director: Lindell Weaver, MD, Intermountain Health Care, Inc.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB#1024157
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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