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| Name | Class |
|---|---|
| Società Italiana Medicina degli Ambienti Estremi | UNKNOWN |
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This pilot study aims to evaluate the efficacy of positive expiratory pressure (PEP) therapy at 10 cmHâ‚‚O in improving peripheral oxygen saturation (SpOâ‚‚) 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 SpOâ‚‚ 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Pilot trial of positive expiratory pressure for acute mountain sickness. 1 single arm with 3 phases:
Each phase is consecutive at altitudes 4,300 m, 5,560 m, and 6,000 m |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Positive Expiratory Pressure (10cmH2O) in hypobaric hypoxia | Device | The intervention under investigation will be the application of positive expiratory pressure (PEP) at 10 cmHâ‚‚O 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Peripheral Oxygen Saturation (SpO2) | During the 3 weeks of expedition on Mount Aconcagua, after arrival of participants at 4300masl, 5560masl and 6000 masl. |
| Measure | Description | Time Frame |
|---|---|---|
| Lake Louise Score | The Lake Louise Score (LLS) is a standardized tool to diagnose Acute Mountain Sickness (AMS). It combines self-reported symptoms (headache, gastrointestinal upset, fatigue/weakness, dizziness/lightheadedness) rated from 0 (none) to 3 (severe). AMS is diagnosed when headache is present plus at least one other symptom, with a total score ≥3. Higher scores reflect greater symptom severity: 3-5 mild AMS, 6-9 moderate, ≥10 severe. The LLS is used in research and expeditions to quantify altitude illness and monitor response to acclimatization or treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Paolo Rodi, MD | Contact | +41766992164 | paolorodi95@gmail.com |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21465903 | Background | Mellor A. Research at high altitudes. J R Army Med Corps. 2011 Mar;157(1):5-7. doi: 10.1136/jramc-157-01-01. | |
| 37847882 | Background | 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. |
| Label | URL |
|---|---|
| Theoretical underpinning | View source |
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| ID | Term |
|---|---|
| D000532 | Altitude Sickness |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| During the 3 weeks of expedition on Mount Aconcagua, after arrival of participants at 4300masl, 5560masl and 6000 masl. |
| 24376872 | Background | 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. |
| 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. |
| 31530174 | Background | 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. |
| 34621182 | Background | 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. |
| 25573419 | Background | 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. |
| 12527602 | Background | 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. |
| 19903683 | Background | 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. |
| 26955891 | Background | 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. |
| 29583031 | Background | 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. |
| 37833187 | Background | 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. |
| 33732460 | Background | 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. |
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| 23809076 | Background | 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. |
| Theoretical underpinning | View source |