NCT04186598

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

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: CommonSpirit Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Continuous Positive Airway Pressure
• High Altitude Pulmonary Edema

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-01-20
• Primary completion: 2023-09-13
• Completion: 2023-09-13
• First posted: 2019-12-05
• Last updated: 2024-02-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study