Evaluating the Utility of Continuous Positive Airway Pressure in the Treatment of High Altitude Pulmonary Edema

Study Purpose

The primary objective is to evaluate the efficacy of continuous positive pressure on resolution of high-altitude pulmonary edema vs.#46;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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

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Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - 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.

Exclusion Criteria:

  • - Pregnancy.
  • - Age below 18.
  • - Patients with respiratory failure requiring intubation.
  • - Patients with altered mental status.
  • - Patients with impaired decision-making capacity.
  • - Patients with a history of congestive heart failure, CAD, COPD, asthma, known current pneumonia.
- Extreme facial hair precluding application of CPAP

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.


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Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

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Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Centura Health
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Todd Bolotin, MD
Principal Investigator Affiliation Centura Health
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Overall Status Recruiting
Countries United States

The disease, disorder, syndrome, illness, or injury that is being studied.

Continuous Positive Airway Pressure, High Altitude Pulmonary Edema
Additional Details

Multicenter, double-blinded, randomized control trial. Enrollment is based on presentation to one of the treating facilities with clinical signs and symptoms of high-altitude pulmonary edema with a recent arrival at high altitude, an oxygen saturation below 85%, and radiographic evidence of noncardiogenic pulmonary edema. A total of 264 patients will be randomized 1:1 across 2 study arms: a CPAP mask set to 15cm H2O and an altered CPAP mask in which the pressure valve has been modified to deliver no positive pressure. All patients will be treated with 30mg nifedipine XR. Except for the application of positive pressure, all other interventions are performed in the context of everyday clinical practice, and thus will be equivalent for participants in both arms. Patients will be evaluated every 30 minutes for their ability to maintain an oxygen saturation of 92% with a normal respiratory rate and no signs of increased work of breathing on 2 liters of nasal cannula oxygen for a total of up to a maximum treatment length of 2 hours. The primary efficacy endpoint will be assessed every 30 minutes for 2 hours.

Arms & Interventions


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.


Device: - CPAP mask system

Intervention group will receive 15cm of H2O of positive end expiratory pressure

Drug: - Nifedipine 30 MG

All participants will receive this intervention

Device: - CPAP mask system without PEEP

Placebo group will receive high flow oxygen via altered CPAP mask system without providing any positive end expiratory pressure

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Breckenridge Medical Center, Breckenridge, Colorado




Breckenridge Medical Center

Breckenridge, Colorado, 80424

Site Contact

Todd Bolotin, MD



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