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

Not Applicable

Completed

• Conditions: Continuous Positive Airway Pressure; High Altitude Pulmonary Edema
• Interventions: Device: CPAP mask system; Drug: Nifedipine 30 MG; Device: CPAP mask system without PEEP

• Registration Number: NCT04186598
• Lead Sponsor: CommonSpirit Health

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.

Study Timeline

• Study First Submitted: 2019-12-01
• Study First Submitted QC: 2019-12-03
• Study First Posted: 2019-12-05
• Study Start: 2020-01-20
• Primary Completion: 2023-09-13
• Study Completion: 2023-09-13
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-05
• Last Update Posted: 2024-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental: CPAP	Nifedipine 30 MG	Participants will be treated with CPAP. All patients will be treated with nifedipine unless there is a contraindication like hypotension and bradycardia.
Control: High flow oxygen	CPAP mask system without PEEP	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.
Experimental: CPAP	CPAP mask system	Participants will be treated with CPAP. All patients will be treated with nifedipine unless there is a contraindication like hypotension and bradycardia.
Control: High flow oxygen	Nifedipine 30 MG	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.

Primary Outcome Measures

Name	Time	Method
Time to resolution of HAPE	2 hours	The amount of time it took to maintain oxygen saturation over 92% on 2L NC oxygen

Secondary Outcome Measures

Name	Time	Method
Presence or absence of ultrasound detectable B lines	2 hours	A convenience sample of the total study population will have a bedside pulmonary ultrasound at time zero and two hours
Incidence of HAPE by native altitude and reported sleeping altitude	2 hours	Data will be collected and analyzed to seek a relationship between the subjects home altitude and the altitude of their sleep while at high altitude
Characterization of time at altitude to development of HAPE	2 hours	A descriptive measurement of the time since the patient arrived at altitude until the development of HAPE

Trial Locations

Locations (1)

Breckenridge Medical Center; 🇺🇸 Breckenridge, Colorado, United States