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

NCT ID: NCT06802744

Last Updated: 2025-01-31

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-07
• Study Completion Date: 2025-03-31

Brief Summary

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.

Conditions

Avalanche Burial

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Simulated avalanche burial using a artificial air-pocket device

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Simulated avalanche burial using a non-functional artificial air-pocket device

Group Type: SHAM_COMPARATOR

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

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Klinik fur Pneumologie und Schlafmedizin Kantonsspital Aarau

INDUSTRY

Sponsor Role: lead

Responsible Party

Hans-Joachim Kabitz

Prof. Dr. med.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hans-Joachim Kabitz, Prof. Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Klinik für Pneumologie und Schlafmedizin Kantonsspital Aarau

Locations

Kantonsspital Aarau

Aarau, Canton of Aargau, Switzerland

Countries

Switzerland

Other Identifiers

2024-02335

Identifier Type: -

Identifier Source: org_study_id