NCT04186598

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 1, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 5, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

January 20, 2020

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 13, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 13, 2023

Completed
Last Updated

February 7, 2024

Status Verified

February 1, 2024

Enrollment Period

3.6 years

First QC Date

December 1, 2019

Last Update Submit

February 5, 2024

Conditions

Continuous Positive Airway PressureHigh Altitude Pulmonary Edema

Outcome Measures

Primary Outcomes (1)

  • Time to resolution of HAPE

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

    2 hours

Secondary Outcomes (3)

  • Presence or absence of ultrasound detectable B lines

    2 hours

  • Characterization of time at altitude to development of HAPE

    2 hours

  • Incidence of HAPE by native altitude and reported sleeping altitude

    2 hours

Study Arms (2)

Experimental: CPAP

EXPERIMENTAL

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 systemDrug: Nifedipine 30 MG

Control: High flow oxygen

PLACEBO COMPARATOR

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 MGDevice: CPAP mask system without PEEP

Interventions

CPAP mask systemDEVICE

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

Experimental: CPAP
Nifedipine 30 MGDRUG

All participants will receive this intervention

Control: High flow oxygenExperimental: CPAP
CPAP mask system without PEEPDEVICE

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

Control: High flow oxygen

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Breckenridge Medical Center

Breckenridge, Colorado, 80424, United States

Location

Related Publications (11)

  • 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.

    PMID: 14733848BACKGROUND

  • 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.

    PMID: 29529715BACKGROUND

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

    PMID: 12801752BACKGROUND

  • 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.

    PMID: 15163571BACKGROUND

  • 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.

    PMID: 28653390BACKGROUND

  • 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.

    PMID: 16552275BACKGROUND

  • 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.

    PMID: 31248818BACKGROUND

  • 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.

    PMID: 24067184BACKGROUND

  • 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.

    PMID: 17823137BACKGROUND

  • 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.

    PMID: 24377348BACKGROUND

  • Bolotin T, Subedi S, Dahal S, Walker C, Chung K, Martz A, Gemmel D, Chopra Q, Donley C. High Altitude Pulmonary Edema Response to Continuous Airway Positive Pressure: A Randomized Controlled Trial: The HAPER CAPER Trial. Acad Emerg Med. 2025 Nov;32(11):1215-1223. doi: 10.1111/acem.70126. Epub 2025 Sep 12.

    PMID: 40938265DERIVED

MeSH Terms

Conditions

Altitude Sickness

Interventions

NifedipinePositive-Pressure Respiration

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

DihydropyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsRespiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Todd Bolotin, MD

    CommonSpirit Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
Standard CPAP systems and control CPAP systems that provide high flow oxygen without PEEP
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 1, 2019

First Posted

December 5, 2019

Study Start

January 20, 2020

Primary Completion

September 13, 2023

Study Completion

September 13, 2023

Last Updated

February 7, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)