Multicenter Randomized Double-Blind Control Trial Evaluating the Utility of Continuous Positive Airway Pressure (CPAP) in the Treatment of High Altitude Pulmonary Edema (HAPE)
Status: Completed
Location: See location...
Intervention Type: Device, Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The primary objective is to evaluate the efficacy of continuous positive pressure on resolution of high-altitude pulmonary edema vs high flow oxygen. The secondary objective is to derive an incidence of high-altitude pulmonary edema based on the elevation and timing from which the subject arrives. Additionally, in a convenience sample of the base study population, an ultrasound evaluation for the presence of B lines in the lungs will be conducted after 2 hours.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:
• Male or female, age 18 years or greater
• Oxygen saturation below 85%
• Recent arrival to high altitude
• Dyspnea and cough
• Xray revealing non-cardiogenic pulmonary edema
Locations
United States
Colorado
Breckenridge Medical Center
Breckenridge
Time Frame
Start Date: 2020-01-20
Completion Date: 2023-09-13
Participants
Target number of participants: 64
Treatments
Experimental: Experimental: CPAP
Participants will be treated with CPAP. All patients will be treated with nifedipine unless there is a contraindication like hypotension and bradycardia.
Placebo_comparator: Control: High flow oxygen
Participants will be treated with an altered CPAP mask that will deliver high flow oxygen. All patients will be treated with nifedipine unless there is a contraindication like hypotension and bradycardia.
Related Therapeutic Areas
Sponsors
Leads: CommonSpirit Health
Collaborators: Pulmodyne, Inc.