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Enrolling by Invitation

NCT Number: 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.

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.

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Key information

Conditions

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kantonsspital Aarau

Aarau, Canton of Aargau, 5001, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Addition of an artificial air-pocket device during simulated avalanche burial

Device

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.

Addition of a non-functioning artificial air-pocket device during simulated avalanche burial

Device

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 outcomes

  1. Course of PtCO2 measured transcutaneously

    Time frame: 45 minutes

Secondary outcomes

  1. Burial time until the test is terminated

    Time frame: 45 minutes

  2. Course of PetCO2

    Time frame: 45 minutes

  3. Progression of respiratory minute volume

    Time frame: 45 minutes

  4. Course of the body temperature

    Time frame: 45 minutes

  5. Heart rate progression and variability

    Time frame: 45 minutes

  6. Course of PtO2

    Time frame: 45 minutes

  7. Course of PetO2

    Time frame: 45 minutes

  8. Course of SpO2

    Time frame: 45 minutes

  9. Progression of Respiratory rate

    Time frame: 45 minutes

Sponsors and collaborators

Lead sponsor

Klinik fur Pneumologie und Schlafmedizin Kantonsspital Aarau

Industry

Registry information

Official study title

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

Acronym: Avalanox

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 31, 2025
Registry last updated
Jan 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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