Pre-acclimatization study for an expedition at extreme altitude
Résumé de l'étude
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)
Intervention étudiée
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)
Maladie en cours d'investigation
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)
Critères d'exclusion
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)
Lieu de l’étude
Berne, Zurich, Autre
(BASEC)
Nepal
(BASEC)
Sponsor
Prof. Dr. med. Reto Schüpbach, Institut für Intensivmedizin, Universität Zürich
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Matthias Hilty
+41 43 253 8063
matthias.hilty@clutterusz.chInstitute for Intensive Care Medicine, University Hospital Zurich
(BASEC)
Informations scientifiques
non disponible
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale de Zurich
(BASEC)
Date d'approbation du comité d'éthique
26.07.2022
(BASEC)
Identifiant de l'essai ICTRP
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Titre officiel (approuvé par le comité d'éthique)
The PRe-Acclimatization auGmented extreMe Altitude eXpedition (PRAGMAX) Randomized Controlled Trial (BASEC)
Titre académique
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Titre public
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Maladie en cours d'investigation
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Intervention étudiée
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Type d'essai
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Plan de l'étude
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Critères d'inclusion/exclusion
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Critères d'évaluation principaux et secondaires
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Date d'enregistrement
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Inclusion du premier participant
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Sponsors secondaires
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Contacts supplémentaires
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ID secondaires
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Résultats-Données individuelles des participants
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Informations complémentaires sur l'essai
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Résultats de l'essai
Résumé des résultats
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Lien vers les résultats dans le registre primaire
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