Clinical trial NCT04186598: Evaluating the Utility of Continuous Positive Airway Pressure in the Treatment of High Altitude Pulmonary Edema
Official title: Multicenter Randomized Double-Blind Control Trial Evaluating the Utility of Continuous Positive Airway Pressure (CPAP) in the Treatment of High Altitude Pulmonary Edema (HAPE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Continuous Positive Airway Pressure
High Altitude Pulmonary Edema
Lead sponsor: CommonSpirit Health
Sponsor class: OTHER
Collaborators: name: Pulmodyne, Inc.
First posted: 2019-12-05
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Time to resolution of HAPE
timeFrame: 2 hours
Secondary outcomes:
measure: Presence or absence of ultrasound detectable B lines
timeFrame: 2 hours
measure: Characterization of time at altitude to development of HAPE
timeFrame: 2 hours
measure: Incidence of HAPE by native altitude and reported sleeping altitude
timeFrame: 2 hours
Other outcomes:
Locations:
city: Breckenridge
country: United States
facility: Breckenridge Medical Center
state: Colorado
Study officials:
affiliation: CommonSpirit Health
name: Todd Bolotin, MD
role: PRINCIPAL_INVESTIGATOR
References:
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