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

NCT06802744 | Enrolling By Invitation

• 1 other identifier: 2024-02335
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Keywords

AAPD; Artificial air-pocket device

Outcome Measures

Primary Outcomes (1)

• Course of PtCO2 measured transcutaneously

  45 minutes

Secondary Outcomes (9)

• Burial time until the test is terminated

  45 minutes

• Course of PetCO2

  45 minutes

• Progression of respiratory minute volume

  45 minutes

• Course of the body temperature

  45 minutes

• Heart rate progression and variability

  45 minutes

Study Arms (2)

Simulated avalanche burial using a artificial air-pocket device

EXPERIMENTAL

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

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

SHAM COMPARATOR

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

Interventions

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.

Simulated avalanche burial using a artificial air-pocket device

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.

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

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Adults over 18
• Able to consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Klinik fur Pneumologie und Schlafmedizin Kantonsspital Aarau: lead

Study Sites (1)

Kantonsspital Aarau

Aarau, Canton of Aargau, 5001, Switzerland

Location

Study Officials

• Hans-Joachim Kabitz, Prof. Dr. med.

  Klinik für Pneumologie und Schlafmedizin Kantonsspital Aarau

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: January 20, 2025
• First Posted: January 31, 2025
• Study Start: February 7, 2025
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: January 31, 2025

Record last verified: 2025-01

Locations

CH (1)