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

Continuous Positive Airway Pressure Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04186598
• Other study ID #: 1389613
• Status: Completed
• Phase: N/A
• Start date: January 20, 2020
• Est. completion date: September 13, 2023

Study information

• Verified date: February 2024
• Source: Centura Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: September 13, 2023
• Est. primary completion date: September 13, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Altitude Sickness
• Continuous Positive Airway Pressure
• Edema
• High Altitude Pulmonary Edema
• Hypertension, Pulmonary
• Pulmonary Edema

Intervention

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

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

Locations

Country	Name	City	State
United States	Breckenridge Medical Center	Breckenridge	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
Centura Health	Pulmodyne, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (10)

Basnyat B, Murdoch DR. High-altitude illness. Lancet. 2003 Jun 7;361(9373):1967-74. doi: 10.1016/S0140-6736(03)13591-X. — View Citation

Gallagher SA, Hackett PH. High-altitude illness. Emerg Med Clin North Am. 2004 May;22(2):329-55, viii. doi: 10.1016/j.emc.2004.02.001. — View Citation

Gonzalez Garay A, Molano Franco D, Nieto Estrada VH, Marti-Carvajal AJ, Arevalo-Rodriguez I. Interventions for preventing high altitude illness: Part 2. Less commonly-used drugs. Cochrane Database Syst Rev. 2018 Mar 12;3(3):CD012983. doi: 10.1002/14651858.CD012983. — View Citation

Hebert PC, Stanbrook M. Indication creep: physician beware. CMAJ. 2007 Sep 25;177(7):697, 699. doi: 10.1503/cmaj.071223. Epub 2007 Sep 5. No abstract available. — View Citation

Johnson PL, Johnson CC, Poudyal P, Regmi N, Walmsley MA, Basnyat B. Continuous positive airway pressure treatment for acute mountain sickness at 4240 m in the Nepal Himalaya. High Alt Med Biol. 2013 Sep;14(3):230-3. doi: 10.1089/ham.2013.1015. — View Citation

Luks AM, Auerbach PS, Freer L, Grissom CK, Keyes LE, McIntosh SE, Rodway GW, Schoene RB, Zafren K, Hackett PH. Wilderness Medical Society Clinical Practice Guidelines for the Prevention and Treatment of Acute Altitude Illness: 2019 Update. Wilderness Environ Med. 2019 Dec;30(4S):S3-S18. doi: 10.1016/j.wem.2019.04.006. Epub 2019 Jun 24. — View Citation

Murdoch DR. Prevention and Treatment of High-altitude Illness in Travelers. Curr Infect Dis Rep. 2004 Feb;6(1):43-49. doi: 10.1007/s11908-004-0023-4. — View Citation

Nieto Estrada VH, Molano Franco D, Medina RD, Gonzalez Garay AG, Marti-Carvajal AJ, Arevalo-Rodriguez I. Interventions for preventing high altitude illness: Part 1. Commonly-used classes of drugs. Cochrane Database Syst Rev. 2017 Jun 27;6(6):CD009761. doi: 10.1002/14651858.CD009761.pub2. — View Citation

Stoltzfus S. The role of noninvasive ventilation: CPAP and BiPAP in the treatment of congestive heart failure. Dimens Crit Care Nurs. 2006 Mar-Apr;25(2):66-70. doi: 10.1097/00003465-200603000-00006. — View Citation

Walmsley M. Continuous positive airway pressure as adjunct treatment of acute altitude illness. High Alt Med Biol. 2013 Dec;14(4):405-7. doi: 10.1089/ham.2013.1059. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to resolution of HAPE	The amount of time it took to maintain oxygen saturation over 92% on 2L NC oxygen	2 hours
Secondary	Presence or absence of ultrasound detectable B lines	A convenience sample of the total study population will have a bedside pulmonary ultrasound at time zero and two hours	2 hours
Secondary	Characterization of time at altitude to development of HAPE	A descriptive measurement of the time since the patient arrived at altitude until the development of HAPE	2 hours
Secondary	Incidence of HAPE by native altitude and reported sleeping altitude	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	2 hours