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

Centura Health

Status: Completed

Conditions: Continuous Positive Airway Pressure; High Altitude Pulmonary Edema

Treatments: Device: CPAP mask system without PEEP; Device: CPAP mask system; Drug: Nifedipine 30 MG

Study type: Interventional

Funder types: Other

Identifiers

NCT04186598

1389613

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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64 participants in 2 patient groups, including a placebo group

Experimental: CPAP

Experimental group

Description:

Participants will be treated with CPAP. All patients will be treated with nifedipine unless there is a contraindication like hypotension and bradycardia.

Treatment:

Device: CPAP mask system

Drug: Nifedipine 30 MG

Control: High flow oxygen

Placebo Comparator group

Description:

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.

Treatment:

Drug: Nifedipine 30 MG

Device: CPAP mask system without PEEP