CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 64 enrolled
Drug / intervention
Nifedipine 30 MG +2 moredrug
Likely dose
Nifedipine 30 MGfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04186598
NCT04186598N/ACompleted

Multicenter Randomized Double-Blind Control Trial Evaluating the Utility of Continuous Positive Airway Pressure (CPAP) in the Treatment of High Altitude Pulmonary Edema (HAPE)

CommonSpirit Health·interventional·Posted Dec 5, 2019·Updated Feb 7, 2024

In Brief

A clinical study evaluating CPAP mask system, Nifedipine 30 MG, and 1 other intervention for Continuous Positive Airway Pressure and High Altitude Pulmonary Edema. Completed, enrolled 64 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsPulmodyne, Inc.

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedDec 5, 2019
Enrollment StartJan 20, 2020
Primary CompletionSep 13, 2023
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 6.6 years ago

Interventions

CPAP mask systemdevice

Intervention group will receive 15cm of H2O of positive end expiratory pressure

Nifedipine 30 MGdrug

All participants will receive this intervention

CPAP mask system without PEEPdevice

Placebo group will receive high flow oxygen via altered CPAP mask system without providing any positive end expiratory pressure