The PRe-Acclimatization auGmented extreMe Altitude eXpedition (PRAGMAX) study

University of Zurich is starting a new clinical trial of The Pre-acclimatization Augmented Extreme Altitude Expedition.

The aim of this study is to investigate the effect of pre-acclimatization in a nitrogen tent at home, ventilated with a slightly increased nitrogen percentage, in preparation for an expedition at extreme altitude. Specifically, the current study aims to gather knowledge, whether pre-acclimatization, first, leads to improved capillary function during an expedition to extreme altitude, and second, affects incidence of altitude sickness and the likelihood of reaching the expedition destination without oxygen supplementation. The project will be carried out in two phases corresponding to two randomized controlled trials in healthy volunteers, who are participating in an expedition at extreme altitudes with or without pre-acclimatization.

The immediate effects of nitrogen concentration tent preacclimatization are assessed through continuous monitoring of oxygen partial pressure in the tent and the hemoglobin oxygen saturation throughout preacclimatization.

To test whether preacclimatization is associated with physiologic adaptation, tissue red blood cell perfusion as a main contributor to increase oxygen delivery capacity in the microcirculation throughout acclimatization to extreme altitude, is assessed using non-invasive handheld vital microscopy during preacclimatization and throughout the expedition, and the incidence and severity of high-altitude related disease and summit success, are recorded during the expeditions.

The clinical trial started in August 4, 2022 and will continue throughout December 2023.

For more details: https://ichgcp.net/clinical-trials-registry/NCT05517044.