Title
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)
Phase
N/ALead Sponsor
Centura HealthStudy Type
InterventionalStatus
RecruitingIndication/Condition
Continuous Positive Airway Pressure High Altitude Pulmonary EdemaIntervention/Treatment
Nifedipine 30 MG ...Study Participants
264The 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.
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.
Intervention group will receive 15cm of H2O of positive end expiratory pressure
All participants will receive this intervention
Placebo group will receive high flow oxygen via altered CPAP mask system without providing any positive end expiratory pressure
Participants will be treated with CPAP. All patients will be treated with nifedipine unless there is a contraindication like hypotension and bradycardia.
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.
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
