Continuous Positive Airway Pressure, High Altitude Pulmonary Edema
Conditions
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.
Interventions
DEVICECPAP mask system
Intervention group will receive 15cm of H2O of positive end expiratory pressure
DRUGNifedipine 30 MG
All participants will receive this intervention
DEVICECPAP mask system without PEEP
Placebo group will receive high flow oxygen via altered CPAP mask system without providing any positive end expiratory pressure
Sponsors
Pulmodyne, Inc.
CommonSpirit Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
Standard CPAP systems and control CPAP systems that provide high flow oxygen without PEEP
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to resolution of HAPE | 2 hours | The amount of time it took to maintain oxygen saturation over 92% on 2L NC oxygen |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
Countries
United States
Outcome results
None listed