Efficacy of Positive Expiratory Pressure on Acute Mountain Sickness
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Positive Expiratory Pressure (10cmH2O) in hypobaric hypoxia.
- Who it may be relevant to
- Registry conditions: Acute Mountain Sickness (AMS). Basic parameters: 18 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Efficacy of Positive Expiratory Pressure on Acute Mountain Sickness, a Pilot Crossover Trial at 6000 Meters
Overview
This pilot study aims to evaluate the efficacy of positive expiratory pressure (PEP) therapy at 10 cmH₂O in improving peripheral oxygen saturation (SpO₂) and mitigating symptoms of acute mountain sickness (AMS) in healthy individuals exposed to extreme altitude conditions. 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.
Interventions
- Device 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.
Primary outcome measures
- Peripheral Oxygen Saturation (SpO2) [Time frame: During the 3 weeks of expedition on Mount Aconcagua, after arrival of participants at 4300masl, 5560masl and 6000 masl.]
Secondary outcome measures (1)
- Lake Louise Score [Time frame: During the 3 weeks of expedition on Mount Aconcagua, after arrival of participants at 4300masl, 5560masl and 6000 masl.]
Eligibility criteria
Inclusion criteria
- Healthy volunteers without ongoing medical conditions
- 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
- Subjects with any ongoing medical conditions
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- Mellor A. Research at high altitudes. J R Army Med Corps. 2011 Mar;157(1):5-7. doi: 10.1136/jramc-157-01-01. PMID 21465903
- 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. PMID 37847882
- 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. PMID 24376872
- 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 24067184
- 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. PMID 31530174
- 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. PMID 34621182
- 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. PMID 25573419
- 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. PMID 12527602
Identifiers
NCT: NCT07148674 · 6962