The Pre-acclimatization Augmented Extreme Altitude Expedition

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Brief Title

The Pre-acclimatization Augmented Extreme Altitude Expedition

Official Title

The PRe-Acclimatization auGmented extreMe Altitude eXpedition (PRAGMAX) Randomized Controlled Trial

Brief Summary

      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.
    

Detailed Description

      Expeditions to the world's highest peaks are attempted by increasing numbers of alpinists,
      taking advantage of broad commercial support. At extreme altitude successful functioning, and
      even survival, are only possible with adequate acclimatization, which consists of
      time-consuming exposure to gradually higher sleeping altitudes. Generally, an increase in
      300-600 m per day at altitudes above 3000 m, and the minimization of cumulative time spend
      above 6500 m, are considered safe practice. Mainly in an attempt to accelerate expeditions to
      extreme altitudes, a preacclimatization technique using nitrogen concentration tent induced
      normobaric hypoxia is increasingly employed in practice, and already part commercial
      expedition plans. Some previous research indicates that intermittent normobaric hypoxia may
      reduce the incidence of acute mountain sickness, while the results from other studies remain
      inconclusive or negative. One study has not found serious adverse effects related to
      intermittent normobaric hypoxia, such as high-altitude pulmonary or cerebral edema.

      Thus, despite the emergence of increasing numbers of commercial expedition programs making
      use of nitrogen concentration tent preacclimatization protocols, many factors remain unclear.
      Next to remaining uncertainties regarding the extent of the hypoxic condition induced by
      these devices, current data does not allow adequate conclusions regarding the choice of
      optimal preacclimatization protocol, optimal associated ascent profiles, and possible effects
      on oxygen delivery capacity to the tissue, incidence of high-altitude related disease, and
      even summit success. Thus, the present study aims to conduct a randomized controlled trial to
      assess the efficacy of nitrogen concentration tent preacclimatization as part of two
      expeditions to extreme altitude. 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.
    


Study Type

Interventional


Primary Outcome

Difference in sublingual total capillary vessel density (TVD) induced by preacclimatization and high-altitude exposure (change from baseline)

Secondary Outcome

 Change in acute mountain sickness (Lake Louise score)

Condition

Altitude Hypoxia

Intervention

Nitrogen tent preacclimatization to high altitude

Study Arms / Comparison Groups

 Preacclimatization group
Description:  The participants assigned to the preacclimatization group will undergo a defined preacclimatization program by sleeping in a nitrogen concentration tent prior to an expedition to high altitude.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

30

Start Date

August 4, 2022

Completion Date

December 2023

Primary Completion Date

November 2023

Eligibility Criteria

        Inclusion Criteria:

          -  Healthy

          -  Active alpinists (active alpinists denotes individuals with regular experience in
             alpine high mountain climbing in rock, ice and snow terrain of difficulty WS - ZS
             according to the Swiss Alpine Club (SAC-CAS) grading scale assessed in a
             self-reporting questionnaire

          -  age > 18 years

        Exclusion Criteria:

          -  history of high-altitude pulmonary edema or cerebral edema

          -  pregnancy or lactation

          -  heart failure (AHA Stage B and above)

          -  pulmonary hypertension

          -  pulmonary disease excluding mild bronchial asthma

          -  chronic kidney failure (KDIGO Stage 1 and above)

          -  chronic liver disease

          -  subjects with a history of smoking (> 5 PY), and high familiar predisposition for
             cardiovascular disease, when combined with smoking
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Matthias P Hilty, PD Dr. med., +41 43 253 8063, [email protected]

Location Countries

Switzerland

Location Countries

Switzerland

Administrative Informations


NCT ID

NCT05517044

Organization ID

BASEC 2022-00679


Responsible Party

Sponsor

Study Sponsor

University of Zurich

Collaborators

 Swiss Sportclinic Bern

Study Sponsor

Matthias P Hilty, PD Dr. med., Principal Investigator, University of Zurich


Verification Date

August 2022