Efficacy of Positive Expiratory Pressure on Acute Mountain Sickness
NCT ID: NCT07148674
Last Updated: 2025-08-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
3 participants
INTERVENTIONAL
2025-09-05
2025-12-31
Brief Summary
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Three male participants will be monitored during an ascent of Mount Aconcagua, Argentina, at elevations of 4,300 m, 5,560 m, and 6,000 m above sea level. The study involves three sequential phases of 10 minutes each: baseline breathing without PEP, breathing with PEP applied via a mechanical face mask, and post-PEP breathing.
Primary outcomes include changes in SpO₂ and Lake Louise Score (LLS) to assess AMS severity. Findings will provide preliminary data on the potential role of PEP as a non-pharmacological intervention in high-altitude medicine.
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Intervention
Pilot trial of positive expiratory pressure for acute mountain sickness.
1 single arm with 3 phases:
* 1: Baseline Breathing (No PEP) Participants breathe normally without any device for 10 minutes in supine position, serving as control.
* 2: Positive Expiratory Pressure (PEP) Breathing Participants breathe through a face mask with a mechanical PEP device set at 10 cmH₂O expiratory pressure for 10 minutes supine. Inspiration is unrestricted; expiration occurs against resistance to improve oxygenation and reduce AMS symptoms.
* 3: Post-PEP Breathing (No PEP) After PEP, participants breathe normally for 10 minutes supine.
Each phase is consecutive at altitudes 4,300 m, 5,560 m, and 6,000 m
Positive Expiratory Pressure (10cmH2O) in hypobaric hypoxia
The intervention under investigation will be the application of positive expiratory pressure (PEP) at 10 cmH₂O using an Ambu mask. The mask will allow participants to inspire freely while generating a controlled expiratory pressure. The PEP device is a non-pharmacological medical device whose uses in both hospital and pre-hospital settings are part of everyday medical practice.
Interventions
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Positive Expiratory Pressure (10cmH2O) in hypobaric hypoxia
The intervention under investigation will be the application of positive expiratory pressure (PEP) at 10 cmH₂O using an Ambu mask. The mask will allow participants to inspire freely while generating a controlled expiratory pressure. The PEP device is a non-pharmacological medical device whose uses in both hospital and pre-hospital settings are part of everyday medical practice.
Eligibility Criteria
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Inclusion Criteria
* Over 18 years of age
* Volunteers with the physical and technical skills necessary to undertake a mountaineering expedition on Mount Aconcagua, Argentina, and with previous experience at extreme altitudes
Exclusion Criteria
* Under 18 years of age
* Subjects without previous mountaineering experience at extreme altitudes and without adequate physical and technical preparation necessary to undertake a mountaineering expedition on Mount Aconcagua, Argentina
18 Years
99 Years
ALL
Yes
Sponsors
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Società Italiana Medicina degli Ambienti Estremi
UNKNOWN
BiALP - Alpine, Disaster and Wilderness Medicine
OTHER
Responsible Party
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Paolo Rodi
MD, MScMD, principal investigator
Central Contacts
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References
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Mellor A. Research at high altitudes. J R Army Med Corps. 2011 Mar;157(1):5-7. doi: 10.1136/jramc-157-01-01.
Wu J, Wu Y, Wang L, Ye H, Lu J, Li Y. Challenges and Advances in Rechargeable Batteries for Extreme-Condition Applications. Adv Mater. 2024 Jan;36(4):e2308193. doi: 10.1002/adma.202308193. Epub 2023 Nov 28.
Nespoulet H, Rupp T, Bachasson D, Tamisier R, Wuyam B, Levy P, Verges S. Positive expiratory pressure improves oxygenation in healthy subjects exposed to hypoxia. PLoS One. 2013 Dec 23;8(12):e85219. doi: 10.1371/journal.pone.0085219. eCollection 2013.
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.
Rupp T, Saugy JJ, Bourdillon N, Verges S, Millet GP. Positive expiratory pressure improves arterial and cerebral oxygenation in acute normobaric and hypobaric hypoxia. Am J Physiol Regul Integr Comp Physiol. 2019 Nov 1;317(5):R754-R762. doi: 10.1152/ajpregu.00025.2019. Epub 2019 Sep 18.
Rupp T, Maufrais C, Walther G, Esteve F, Macdonald JH, Bouzat P, Verges S. MEDEX 2015: Prophylactic Effects of Positive Expiratory Pressure in Trekkers at Very High Altitude. Front Physiol. 2021 Sep 21;12:710622. doi: 10.3389/fphys.2021.710622. eCollection 2021.
Fagevik Olsen M, Lannefors L, Westerdahl E. Positive expiratory pressure - Common clinical applications and physiological effects. Respir Med. 2015 Mar;109(3):297-307. doi: 10.1016/j.rmed.2014.11.003. Epub 2014 Nov 12.
Gabry AL, Ledoux X, Mozziconacci M, Martin C. High-altitude pulmonary edema at moderate altitude (< 2,400 m; 7,870 feet): a series of 52 patients. Chest. 2003 Jan;123(1):49-53. doi: 10.1378/chest.123.1.49.
Agostoni P, Caldara G, Bussotti M, Revera M, Valentini M, Gregorini F, Faini A, Lombardi C, Bilo G, Giuliano A, Veglia F, Savia G, Modesti PA, Mancia G, Parati G; HIGHCARE Investigators. Continuous positive airway pressure increases haemoglobin O2 saturation after acute but not prolonged altitude exposure. Eur Heart J. 2010 Feb;31(4):457-63. doi: 10.1093/eurheartj/ehp472. Epub 2009 Nov 10.
Wang C, Wang X, Chi C, Guo L, Guo L, Zhao N, Wang W, Pi X, Sun B, Lian A, Shi J, Li E. Lung ventilation strategies for acute respiratory distress syndrome: a systematic review and network meta-analysis. Sci Rep. 2016 Mar 9;6:22855. doi: 10.1038/srep22855.
Roach RC, Hackett PH, Oelz O, Bartsch P, Luks AM, MacInnis MJ, Baillie JK; Lake Louise AMS Score Consensus Committee. The 2018 Lake Louise Acute Mountain Sickness Score. High Alt Med Biol. 2018 Mar;19(1):4-6. doi: 10.1089/ham.2017.0164. Epub 2018 Mar 13.
Luks AM, Beidleman BA, 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, Diagnosis, and Treatment of Acute Altitude Illness: 2024 Update. Wilderness Environ Med. 2024 Mar;35(1_suppl):2S-19S. doi: 10.1016/j.wem.2023.05.013. Epub 2023 Dec 27.
Woods P, Alcock J. High-altitude pulmonary edema. Evol Med Public Health. 2021 Jan 6;9(1):118-119. doi: 10.1093/emph/eoaa052. eCollection 2021.
Hackett PH, Rennie D, Levine HD. The incidence, importance, and prophylaxis of acute mountain sickness. Lancet. 1976 Nov 27;2(7996):1149-55. doi: 10.1016/s0140-6736(76)91677-9.
Netzer N, Strohl K, Faulhaber M, Gatterer H, Burtscher M. Hypoxia-related altitude illnesses. J Travel Med. 2013 Jul-Aug;20(4):247-55. doi: 10.1111/jtm.12017. Epub 2013 Mar 11.
Related Links
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Theoretical underpinning
Theoretical underpinning
Other Identifiers
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6962
Identifier Type: -
Identifier Source: org_study_id