Pre-acclimatization study for an expedition at extreme altitude
Descrizione riassuntiva dello studio
During exposure to extreme altitude, the human body adapts to the reduced oxygen content of the inhaled air to enable survival and performance in this environment. Many processes in almost all organ systems play a role. Among other things, the oxygen supply to the tissues is improved by recruiting the smallest blood vessels (capillaries). The totality of all adaptation processes is called hypoxic acclimatization. The most important means to positively influence acclimatization is the choice of an appropriate ascent profile. A new approach is to achieve at least partial acclimatization even before the start of an expedition at extreme altitude. This is done through nightly exposure to a mild oxygen deficiency in a tent enriched with nitrogen from the air, where one spends the night at home for several weeks. However, despite apparent success in application, it is unclear what benefits and risks this method entails, and how it should be optimally utilized. In the current study, insights will be gathered to determine whether pre-acclimatization leads to improved capillary function and, during an expedition at extreme altitude, to a reduced incidence of altitude sickness and an influence on the likelihood of reaching the expedition goal without oxygen supplementation. This study will be conducted in accordance with Swiss legislation and according to internationally recognized guidelines. It has been approved by the competent independent ethics committee of the canton.
(BASEC)
Intervento studiato
Participants in the study will be randomly assigned to two groups. The first group will undertake the expedition without specific pre-acclimatization (control group). Participants in the second group (intervention group) will spend at least six hours of sleep in a nitrogen concentration tent (so-called hypoxia tent) during the entire acclimatization period (four weeks before the expedition), simulating the oxygen-poor ambient air at 3500 m above sea level.
(BASEC)
Malattie studiate
This study aims to investigate whether regular nightly stays in a hypoxia tent, as a preparation method for an expedition at extreme altitude, are helpful for healthy, active mountaineers by reducing the occurrence of altitude sickness and thus increasing the likelihood of achieving expedition goals.
(BASEC)
Healthy, active mountaineers over the age of 18. Active mountaineers are individuals with regular experience in alpine high-altitude climbing in rocky, icy, and snowy terrain of difficulty WS - ZS according to the grading scale of the Swiss Alpine Club (SAC-CAS). (BASEC)
Criteri di esclusione
Exclusion criteria include pulmonary edema or cerebral edema in the medical history, pregnancy or breastfeeding, heart failure (AHA stage B and higher), pulmonary hypertension, lung disease except for mild bronchial asthma, chronic kidney failure (KDIGO stage 1 and higher), chronic liver disease, history of smoking (> 5 years), and high familial predisposition to cardiovascular diseases in combination with smoking. (BASEC)
Luogo dello studio
Berna, Zurigo, Altro
(BASEC)
Nepal
(BASEC)
Sponsor
Prof. Dr. med. Reto Schüpbach, Institut für Intensivmedizin, Universität Zürich
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Matthias Hilty
+41 43 253 8063
matthias.hilty@clutterusz.chInstitute for Intensive Care Medicine, University Hospital Zurich
(BASEC)
Informazioni scientifiche
non disponibile
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione etica Zurigo
(BASEC)
Data di approvazione del comitato etico
26.07.2022
(BASEC)
ID di studio ICTRP
non disponibile
Titolo ufficiale (approvato dal comitato etico)
The PRe-Acclimatization auGmented extreMe Altitude eXpedition (PRAGMAX) Randomized Controlled Trial (BASEC)
Titolo accademico
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Risultati dello studio
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