Avalanche BurialAvalanoxNCT06802744
Changes in the Carbon Dioxide Content in the Body During a Simulated Avalanche Burial With and Without the Use of a Breathing Tube System.
A study testing Addition of an artificial air-pocket device during simulated avalanche burial and Addition of a non-functioning artificial air-pocket device during simulated avalanche burial in people with Avalanche Burial, run by Klinik fur Pneumologie und Schlafmedizin Kantonsspital Aarau at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Avalanche Burial
- What is being tested?
- Addition of an artificial air-pocket device during simulated avalanche burial and Addition of a non-functioning artificial air-pocket device during simulated avalanche burial
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteSwitzerland
- Study dates
- 7 Feb 2025to Mar 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults over 18
- Able to consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read more
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
- Being tested
- Addition of an artificial air-pocket device during simulated avalanche burial, Addition of a non-functioning artificial air-pocket device during simulated avalanche burial
- Keywords
- AAPD, Artificial air-pocket device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Addition of an artificial air-pocket device during simulated avalanche burialDevice
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 burialDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Simulated avalanche burial using a artificial air-pocket device | Experimental | Not described Receives: 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 | Not described Receives: Device: Addition of a non-functioning artificial air-pocket device during simulated avalanche burial |
What is being measured
The primary outcome is the main question the study is designed to answer.
Course of PtCO2 measured transcutaneously
Measured: 45 minutes
Secondary outcomes (9)
Burial time until the test is terminated
Measured: 45 minutes
Course of PetCO2
Measured: 45 minutes
Progression of respiratory minute volume
Measured: 45 minutes
Course of the body temperature
Measured: 45 minutes
Heart rate progression and variability
Measured: 45 minutes
Course of PtO2
Measured: 45 minutes
Course of PetO2
Measured: 45 minutes
Course of SpO2
Measured: 45 minutes
Progression of Respiratory rate
Measured: 45 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2025
- Study start7 Feb 2025 (estimated)
- Primary completionMar 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Avalanche BurialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Klinik fur Pneumologie und Schlafmedizin Kantonsspital Aarau
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Hans-Joachim Kabitz, Kantonsspital Aarau
- Investigators
- Hans-Joachim Kabitz, Prof. Dr. med., Principal investigator, Klinik für Pneumologie und Schlafmedizin Kantonsspital Aarau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06802744
- Sponsor's protocol ID
- 2024-02335
- Acronym
- Avalanox
- Status last verified
- Jan 2025
- First submitted
- 20 Jan 2025
- Last updated
- 31 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 42070761
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06802744
- Acronym / sponsor ID
- Avalanox / 2024-02335
- Conditions
- Avalanche Burial
- Keywords
- AAPD, Artificial air-pocket device
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Klinik fur Pneumologie und Schlafmedizin Kantonsspital AarauIndustry (pharma, biotech, devices)
- Study start
- 7 Feb 2025 (estimated)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 31 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Adults over 18
- Able to consent
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Addition of an artificial air-pocket device during simulated avalanche burialIn 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 | Simulated avalanche burial using a artificial air-pocket device |
| Addition of a non-functioning artificial air-pocket device during simulated avalanche burialIn 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. | Device | Simulated avalanche burial using a non-functional artificial air-pocket device |
Primary outcome
Course of PtCO2 measured transcutaneously
Time frame: 45 minutes
9 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2025.
- Derived from this study: PubMed 42070761Schaerli 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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hans-Joachim Kabitz, Prof. Dr. med. principal investigator
Klinik für Pneumologie und Schlafmedizin Kantonsspital Aarau
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Addition of an artificial air-pocket device during simulated avalanche burial and Addition of a non-functioning artificial air-pocket device during simulated avalanche burial in people with Avalanche Burial, run by Klinik fur Pneumologie und Schlafmedizin Kantonsspital Aarau at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 31 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Course of PtCO2 measured transcutaneously (time frame: 45 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06802744, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2025.