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Enrolling by invitation NCT06802744

Changes in the Carbon Dioxide Content in the Body During a Simulated Avalanche Burial With and Without the Use of a Breathing Tube System.

No phase Interventional Avalanche Burial

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Addition of an artificial air-pocket device during simulated avalanche burial, Addition of a non-functioning artificial air-pocket device during simulated avalanche burial.
Who it may be relevant to
Registry conditions: Avalanche Burial. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Changes in Systemic Carbon Dioxide Levels During Simulated Avalanche Burial Using a One-way Valve Device: a Double Blinded, Randomized Cross-over Trial

Overview

Every year, around 100 people die in avalanches in the Alps. Many of these accidents occur during winter sports. In most cases, the victims suffocate under the snow after the avalanche has come to a standstill. A key survival factor here is the time it takes to be rescued. If a buried victim is rescued within 15 minutes, the probability of survival is over 90%. After 35 minutes, however, this drops drastically to just 30%. A modern avalanche rescue system, such as the AvaLung-device, could extend the survival time. The system directs the exhaled air via a tube to the back of the buried person so that no toxic CO2 concentrations build up in the available breathing cavity. It is also intended to prevent the formation of an "ice mask", which can impair the release of oxygen from the snow. This study investigates whether the AvaLung system can extend the survival time in the event of burial. The aim is to test the effects of such a breathing tube system. The oxygen and carbon dioxide levels of the test subjects are measured while they are buried in a simulated avalanche - once with and once without the AvaLung system. In addition, it is investigated how long it takes before the buried subjects have to stop the examination, for example due to shortness of breath or deteriorating respiratory gases in the blood. Test setup: The test subjects lie on their backs with their heads and chests buried under snow. During the test phase, various parameters are continuously monitored, such as the breathing rate and the CO2 concentration in the blood. A comparative study is carried out: once with a functioning rescue system, and once with a manipulated (non-functioning) system. Expected benefit: The results of this study should contribute to a better understanding of the effectiveness of avalanche rescue systems and thus increase the chances of survival of avalanche victims in the future. This is particularly important today, as the number of winter sports enthusiasts and the number of avalanches triggered by them is constantly increasing.

Interventions

  • Device Addition of an artificial air-pocket device during simulated avalanche burial
    In contrast to the control group, the subjects in this arm are provided with a functioning device that directs the exhaled air away from the area of the respiratory cavity.
  • Device Addition of a non-functioning artificial air-pocket device during simulated avalanche burial
    In contrast to the intervention arm, the subjects in this arm are provided with a non-functioning artificial air-pocket device which does not redirect the exhaled air away from the breathing-cavity.

Primary outcome measures

  • Course of PtCO2 measured transcutaneously [Time frame: 45 minutes]
Secondary outcome measures (9)
  • Burial time until the test is terminated [Time frame: 45 minutes]
  • Course of PetCO2 [Time frame: 45 minutes]
  • Progression of respiratory minute volume [Time frame: 45 minutes]
  • Course of the body temperature [Time frame: 45 minutes]
  • Heart rate progression and variability [Time frame: 45 minutes]
  • Course of PtO2 [Time frame: 45 minutes]
  • Course of PetO2 [Time frame: 45 minutes]
  • Course of SpO2 [Time frame: 45 minutes]
  • Progression of Respiratory rate [Time frame: 45 minutes]

Eligibility criteria

Inclusion criteria

  • Adults over 18
  • Able to consent

Exclusion criteria

  • Anamnestic evidence of previous pulmonary or cardiac disease
  • Known neuromuscular diseases
  • Thoracic deformities
  • Acute respiratory infections
  • In women: Pregnancy (excluded by history and urine test)
  • Age over 60 Years
  • Presence of claustrophobia

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Double blind
Primary purpose
Basic science

Study locations

Switzerland · 1 center
  • Kantonsspital Aarau — Aarau

Publications

  • Schaerli F, Buse S, Farquharson F, Weiss B, Klenze H, Allen R, Walterspacher S, Gruber M, Schuetz P, Spengler CM, Kabitz HJ. Changes in systemic carbon dioxide levels during simulated avalanche burial using a one-way valve device: A randomized, double-blind, crossover trial. Respir Physiol Neurobiol. 2026 Jul;343:104588. doi: 10.1016/j.resp.2026.104588. Epub 2026 May 1. PMID 42070761

Identifiers

NCT: NCT06802744 · 2024-02335

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗