Skip to main content
OpenTrials
Completed

NCT Number: NCT04186598

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Breckenridge Medical Center

Breckenridge, Colorado, 80424, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CPAP mask system

Device

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

Nifedipine 30 MG

Drug

All participants will receive this intervention

CPAP mask system without PEEP

Device

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

Primary outcomes

  1. Time to resolution of HAPE

    Time frame: 2 hours

    The amount of time it took to maintain oxygen saturation over 92% on 2L NC oxygen

Secondary outcomes

  1. Presence or absence of ultrasound detectable B lines

    Time frame: 2 hours

    A convenience sample of the total study population will have a bedside pulmonary ultrasound at time zero and two hours

  2. Characterization of time at altitude to development of HAPE

    Time frame: 2 hours

    A descriptive measurement of the time since the patient arrived at altitude until the development of HAPE

  3. Incidence of HAPE by native altitude and reported sleeping altitude

    Time frame: 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

Sponsors and collaborators

Lead sponsor

CommonSpirit Health

Other

Collaborators

  • Pulmodyne, Inc.

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Dec 5, 2019
Registry last updated
Feb 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.