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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04186598
Recruitment Status : Recruiting
First Posted : December 5, 2019
Last Update Posted : July 28, 2021
Pulmodyne, Inc.
Information provided by (Responsible Party):
Todd Bolotin, Centura Health

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.

Condition or disease Intervention/treatment Phase
Continuous Positive Airway Pressure High Altitude Pulmonary Edema Device: CPAP mask system Drug: Nifedipine 30 MG Device: CPAP mask system without PEEP Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 264 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Masking Description: Standard CPAP systems and control CPAP systems that provide high flow oxygen without PEEP
Primary Purpose: Treatment
Official 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)
Actual Study Start Date : January 20, 2020
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema
Drug Information available for: Nifedipine

Arm Intervention/treatment
Experimental: Experimental: CPAP
Participants will be treated with CPAP. All patients will be treated with nifedipine unless there is a contraindication like hypotension and bradycardia.
Device: CPAP mask system
Intervention group will receive 15cm of H2O of positive end expiratory pressure

Drug: Nifedipine 30 MG
All participants will receive this intervention

Placebo Comparator: Control: High flow oxygen
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.
Drug: Nifedipine 30 MG
All participants will receive this intervention

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

Primary Outcome Measures :
  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 Outcome Measures :
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04186598

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Contact: Todd Bolotin, MD 3302193838
Contact: Heather Knappe, MSN 9704531010

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United States, Colorado
Breckenridge Medical Center Recruiting
Breckenridge, Colorado, United States, 80424
Contact: Todd Bolotin, MD    330-219-3838   
Contact: Heather Knappe, MSN    9704531010   
Sponsors and Collaborators
Centura Health
Pulmodyne, Inc.
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Principal Investigator: Todd Bolotin, MD Centura Health

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Responsible Party: Todd Bolotin, Principal Investigator, Centura Health Identifier: NCT04186598    
Other Study ID Numbers: 1389613
First Posted: December 5, 2019    Key Record Dates
Last Update Posted: July 28, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Altitude Sickness
Pulmonary Edema
Hypertension, Pulmonary
Respiration Disorders
Respiratory Tract Diseases
Lung Diseases
Vascular Diseases
Cardiovascular Diseases
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Tocolytic Agents
Reproductive Control Agents