Accident Caused by Snow AvalancheHyperAvaSMNCT02521272
Hypercapnia and Gas Exchange Under the Avalanche Snow Model (HyperAvaSM)
A study testing Breathing in the simulated avalanche snow. and air pocket in people with Accident Caused by Snow Avalanche, run by Czech Technical University in Prague at 1 site in Czechia.
Trial summary
The aim of the study is to investigate respiratory parameters of a person in the simulated avalanche snow and consequent use of the measured data for development of a mathematical-physical model of breathing during increasing hypercapnia in the avalanche. Read more about this study
- Who is it for?
- Ages 20 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Accident Caused by Snow Avalanche
- What is being tested?
- Breathing in the simulated avalanche snow. and air pocket
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteCzechia
- Study dates
- Mar 2012to Mar 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants were volunteers from the Czech Army forces, studying at the Military Department of the Faculty of Physical Education and Sport, Charles University in Prague. All subjects were healthy and fit, classified as ASA I, all without a smoking history. The volunteers were highly motivated to participate in the experiment. The entrance examination, completed before the start of the study, included these tests: electrocardiography, blood pressure, spirometry, and assessment of the health conditions and family anamnesis by a physician with a specialty in anesthesia and critical care.
Who cannot join
- The exclusion criteria were Tiffeneau Index less than 0.70 and any cardiovascular or respiratory condition.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hypercapnia and Gas Exchange Under the Simulated Avalanche Snow
The aim of the study is to investigate respiratory parameters of a person in the simulated avalanche snow and consequent use of the measured data for development of a mathematical-physical model of breathing during increasing hypercapnia in the avalanche.
Read the detailed description
The study is a part of a university research project aimed at studying physiological conditions and development of breathing parameters of a person breathing in the simulated avalanche snow. Presence of an air pocket and its size play an important role in survival of victims buried in the avalanche snow. Even small air pockets facilitate breathing, yet they do not provide a significant amount of fresh air for breathing. The investigators hypothesize that the size of the air pocket significantly affects the airflow resistance and work of breathing. The aim of the study is to investigate the effect of the air pocket volume on gas exchange and work of breathing in subjects breathing into the simulated avalanche snow and to test, whether it is possible to breathe with zero air pocket.
- Conditions
- Accident Caused by Snow Avalanche
- Being tested
- Breathing in the simulated avalanche snow., air pocket
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breathing in the simulated avalanche snow.Other
Breathing in the simulated avalanche snow with zero air pocket and one-liter air pocket.
air pocketDevice
Zero air pocket or one-liter air pocket in the snow.
| Study group | Role | What they receive |
|---|---|---|
| air pocket | Experimental | Breathing in the simulated avalanche snow. Receives: Other: Breathing in the simulated avalanche snow.; Device: air pocket |
What is being measured
The primary outcome is the main question the study is designed to answer.
The length of breathing
Time to termination of the breathing experiment due to the decision of the subject, or determined by high End-Tidal CO2 value or by the order by the clinician assessing the health status of the subjects.
Measured: Continuously within 30 minute interval from the beginning of the breathing experiment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2015 (estimated)
- Study startMar 2012
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Accident Caused by Snow AvalancheStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Czech Technical University in Prague
- Sponsor type
- University, hospital or other
- Collaborators
- Charles University, Czech Republic
- Responsible party
- Sponsor
- Investigators
- Karel Roubik, prof., Ph.D., Study director, Czech Technical University in Prague
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02521272
- Sponsor's protocol ID
- VentRes-2015-01-KR
- Acronym
- HyperAvaSM
- Status last verified
- Aug 2015
- First submitted
- 10 Aug 2015
- Last updated
- 13 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Brugger H, Sumann G, Meister R, Adler-Kastner L, Mair P, Gunga HC, Schobersberger W, Falk M. Hypoxia and hypercapnia during respiration into an artificial air pocket in snow: implications for avalanche survival. Resuscitation. 2003 Jul;58(1):81-8. doi: 10.1016/s0300-9572(03)00113-8.
PubMed 12867313Bellani G, Patroniti N, Weismann D, Galbiati L, Curto F, Foti G, Pesenti A. Measurement of pressure-time product during spontaneous assisted breathing by rapid interrupter technique. Anesthesiology. 2007 Mar;106(3):484-90. doi: 10.1097/00000542-200703000-00012.
PubMed 17325506Grissom CK, Radwin MI, Harmston CH, Hirshberg EL, Crowley TJ. Respiration during snow burial using an artificial air pocket. JAMA. 2000 May 3;283(17):2266-71. doi: 10.1001/jama.283.17.2266.
PubMed 10807386
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypercapnia and Gas Exchange Under the Simulated Avalanche Snow
- ClinicalTrials.gov ID
- NCT02521272
- Acronym / sponsor ID
- HyperAvaSM / VentRes-2015-01-KR
- Conditions
- Accident Caused by Snow Avalanche
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Czech Technical University in PragueUniversity, hospital or other
- Collaborators
- Charles University, Czech Republic
- Study start
- Mar 2012
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 13 Aug 2015 (estimated)
- 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.
The aim of the study is to investigate respiratory parameters of a person in the simulated avalanche snow and consequent use of the measured data for development of a mathematical-physical model of breathing during increasing hypercapnia in the avalanche.
Detailed description
The study is a part of a university research project aimed at studying physiological conditions and development of breathing parameters of a person breathing in the simulated avalanche snow. Presence of an air pocket and its size play an important role in survival of victims buried in the avalanche snow. Even small air pockets facilitate breathing, yet they do not provide a significant amount of fresh air for breathing. The investigators hypothesize that the size of the air pocket significantly affects the airflow resistance and work of breathing. The aim of the study is to investigate the effect of the air pocket volume on gas exchange and work of breathing in subjects breathing into the simulated avalanche snow and to test, whether it is possible to breathe with zero air pocket.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| air pocket | Experimental | Other: Breathing in the simulated avalanche snow., Device: air pocketBreathing in the simulated avalanche snow. |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Participants were volunteers from the Czech Army forces, studying at the Military Department of the Faculty of Physical Education and Sport, Charles University in Prague. All subjects were healthy and fit, classified as ASA I, all without a smoking history. The volunteers were highly motivated to participate in the experiment. The entrance examination, completed before the start of the study, included these tests: electrocardiography, blood pressure, spirometry, and assessment of the health conditions and family anamnesis by a physician with a specialty in anesthesia and critical care.
Key exclusion criteria (1 listed)
- The exclusion criteria were Tiffeneau Index less than 0.70 and any cardiovascular or respiratory condition.
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 |
|---|---|---|
| Breathing in the simulated avalanche snow.Breathing in the simulated avalanche snow with zero air pocket and one-liter air pocket. | Other | air pocket |
| air pocketZero air pocket or one-liter air pocket in the snow. | Device | air pocket |
Primary outcome
The length of breathing
Time frame: Continuously within 30 minute interval from the beginning of the breathing experiment
Time to termination of the breathing experiment due to the decision of the subject, or determined by high End-Tidal CO2 value or by the order by the clinician assessing the health status of the subjects.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2015.
- Background: PubMed 12867313Brugger H, Sumann G, Meister R, Adler-Kastner L, Mair P, Gunga HC, Schobersberger W, Falk M. Hypoxia and hypercapnia during respiration into an artificial air pocket in snow: implications for avalanche survival. Resuscitation. 2003 Jul;58(1):81-8. doi: 10.1016/s0300-9572(03)00113-8.
- Background: PubMed 17325506Bellani G, Patroniti N, Weismann D, Galbiati L, Curto F, Foti G, Pesenti A. Measurement of pressure-time product during spontaneous assisted breathing by rapid interrupter technique. Anesthesiology. 2007 Mar;106(3):484-90. doi: 10.1097/00000542-200703000-00012.
- Background: PubMed 10807386Grissom CK, Radwin MI, Harmston CH, Hirshberg EL, Crowley TJ. Respiration during snow burial using an artificial air pocket. JAMA. 2000 May 3;283(17):2266-71. doi: 10.1001/jama.283.17.2266.
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. This study is not recruiting at the moment.
Karel Roubik, prof., Ph.D. study director
Czech Technical University in Prague
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breathing in the simulated avalanche snow. and air pocket in people with Accident Caused by Snow Avalanche, run by Czech Technical University in Prague at 1 site in Czechia.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 13 Aug 2015. 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 Czechia. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The length of breathing (time frame: Continuously within 30 minute interval from the beginning of the breathing experiment). 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 NCT02521272, which also lists 3 linked publications.
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 13 Aug 2015; AzTrials last refreshed its copy on 31 Oct 2026.