Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Pulmodyne, Inc. | UNKNOWN |
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CPAP mask system | Device | Intervention group will receive 15cm of H2O of positive end expiratory pressure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to resolution of HAPE | The amount of time it took to maintain oxygen saturation over 92% on 2L NC oxygen | 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Characterization of time at altitude to development of HAPE |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Todd Bolotin, MD | CommonSpirit Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Breckenridge Medical Center | Breckenridge | Colorado | 80424 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14733848 | Background | 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. | |
| 29529715 | Background | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Standard CPAP systems and control CPAP systems that provide high flow oxygen without PEEP
| 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 |
|
A descriptive measurement of the time since the patient arrived at altitude until the development of HAPE
| 2 hours |
| 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 |
| 12801752 | Background | Basnyat B, Murdoch DR. High-altitude illness. Lancet. 2003 Jun 7;361(9373):1967-74. doi: 10.1016/S0140-6736(03)13591-X. |
| 15163571 | Background | 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. |
| 28653390 | Background | 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. |
| 16552275 | Background | 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. |
| 31248818 | Background | 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. |
| 24067184 | Background | 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. |
| 17823137 | Background | 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. |
| 24377348 | Background | 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. |
| 40938265 | Derived | 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. |
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 11, 2025 | Mar 3, 2025 | 7 |
| ID | Term |
|---|---|
| D000532 | Altitude Sickness |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D009543 | Nifedipine |
| D011175 | Positive-Pressure Respiration |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D012138 | Respiratory Therapy |
Not provided
Not provided