Accident Caused by Snow AvalancheSPAMNCT03413878
Snow Properties and Its Modeling for Studying Gas Exchange Under the Simulated Avalanche Snow
A study testing Breathing in the simulated avalanche snow in people with Accident Caused by Snow Avalanche, run by Czech Technical University in Prague at 2 sites 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 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Accident Caused by Snow Avalanche
- What is being tested?
- Breathing in the simulated avalanche snow
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 2 sitesCzechia
- Study dates
- 29 Jan 2018to 20 May 2022
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy and fit volunteers, classified as The American Society of Anesthesiologists class I
- without a smoking history
Who cannot join
- Tiffeneau Index less than 0.70
- any cardiovascular or respiratory condition
Trial locations and contacts
2 sites in 1 country.
Czechia2 sites
Czech Technical University, Faculty of Biomedical Engineering
Kladno, 272 01
Charles University, Czech Republic
Prague, 162 00
About this study
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.
- Conditions
- Accident Caused by Snow Avalanche
- Being tested
- Breathing in the simulated avalanche snow
- Keywords
- snow, avalanche, hypercapnia, work of breathing
- Medical subject headings
- Hypercapnia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breathing in the simulated avalanche snowOther
Breathing in the simulated wet or dry avalanche snow with a small or large air pocket
| Study group | Role | What they receive |
|---|---|---|
| Wet snow/Small air pocket | Experimental | Breathing in the simulated avalanche snow. Breathing into model of wet avalanche snow with a small air pocket Receives: Other: Breathing in the simulated avalanche snow |
| Dry snow/Small air pocket | Experimental | Breathing in the simulated avalanche snow. Breathing into model of dry avalanche snow with a small air pocket Receives: Other: Breathing in the simulated avalanche snow |
| Wet snow/Large air pocket | Experimental | Breathing in the simulated avalanche snow. Breathing into model of wet avalanche snow with a large air pocket Receives: Other: Breathing in the simulated avalanche snow |
| Dry snow/Large air pocket | Experimental | Breathing in the simulated avalanche snow. Breathing into model of dry avalanche snow with a large air pocket Receives: Other: Breathing in the simulated avalanche snow |
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 tested subject, or determined by high end-tidal carbon dioxide 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 posted29 Jan 2018
- Study start29 Jan 2018
- Primary completion20 May 2022 (estimated)
- Study completion20 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Czech Technical University in Prague
- Sponsor type
- University, hospital or other
- Collaborators
- Charles University, Czech Republic, Ministry of Defence and Armed Forces of the Czech Republic
- Responsible party
- Sponsor
- Investigators
- Karel Roubik, PhD, Principal investigator, Czech Technical University in Prague, FBMI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03413878
- Sponsor's protocol ID
- VentRes-2018-01-KR
- Acronym
- SPAM
- Status last verified
- Feb 2021
- First submitted
- 22 Jan 2018
- Last updated
- 25 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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 10807386Roubik K, Sieger L, Sykora K. Work of Breathing into Snow in the Presence versus Absence of an Artificial Air Pocket Affects Hypoxia and Hypercapnia of a Victim Covered with Avalanche Snow: A Randomized Double Blind Crossover Study. PLoS One. 2015 Dec 14;10(12):e0144332. doi: 10.1371/journal.pone.0144332. eCollection 2015.
PubMed 26666523Strapazzon G, Paal P, Schweizer J, Falk M, Reuter B, Schenk K, Gatterer H, Grasegger K, Dal Cappello T, Malacrida S, Riess L, Brugger H. Effects of snow properties on humans breathing into an artificial air pocket - an experimental field study. Sci Rep. 2017 Dec 15;7(1):17675. doi: 10.1038/s41598-017-17960-4.
PubMed 29247235Roubik K, Sykora K, Sieger L, Ort V, Horakova L, Walzel S. Perlite is a suitable model material for experiments investigating breathing in high density snow. Sci Rep. 2022 Feb 8;12(1):2070. doi: 10.1038/s41598-022-06015-y.
PubMed 35136116
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Snow Properties and Its Modeling for Studying Gas Exchange Under the Simulated Avalanche Snow
- ClinicalTrials.gov ID
- NCT03413878
- Acronym / sponsor ID
- SPAM / VentRes-2018-01-KR
- Conditions
- Accident Caused by Snow Avalanche
- Keywords
- snow, avalanche, hypercapnia, work of breathing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Czech Technical University in PragueUniversity, hospital or other
- Collaborators
- Charles University, Czech Republic, Ministry of Defence and Armed Forces of the Czech Republic
- Study start
- 29 Jan 2018 (actual)
- Primary completion
- 20 May 2022 (estimated)
- Study completion
- 20 May 2022 (estimated)
- First posted
- 29 Jan 2018 (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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Wet snow/Small air pocket | Experimental | Other: Breathing in the simulated avalanche snowBreathing in the simulated avalanche snow. Breathing into model of wet avalanche snow with a small air pocket |
| Dry snow/Small air pocket | Experimental | Other: Breathing in the simulated avalanche snowBreathing in the simulated avalanche snow. Breathing into model of dry avalanche snow with a small air pocket |
| Wet snow/Large air pocket | Experimental | Other: Breathing in the simulated avalanche snowBreathing in the simulated avalanche snow. Breathing into model of wet avalanche snow with a large air pocket |
| Dry snow/Large air pocket | Experimental | Other: Breathing in the simulated avalanche snowBreathing in the simulated avalanche snow. Breathing into model of dry avalanche snow with a large air pocket |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- healthy and fit volunteers, classified as The American Society of Anesthesiologists class I
- without a smoking history
Key exclusion criteria (2 listed)
- Tiffeneau Index less than 0.70
- 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 snowBreathing in the simulated wet or dry avalanche snow with a small or large air pocket | Other | Dry snow/Large air pocket, Dry snow/Small air pocket, Wet snow/Large air pocket, Wet snow/Small 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 tested subject, or determined by high end-tidal carbon dioxide value or by the order by the clinician assessing the health status of the subjects.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2021.
- 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.
- Background: PubMed 26666523Roubik K, Sieger L, Sykora K. Work of Breathing into Snow in the Presence versus Absence of an Artificial Air Pocket Affects Hypoxia and Hypercapnia of a Victim Covered with Avalanche Snow: A Randomized Double Blind Crossover Study. PLoS One. 2015 Dec 14;10(12):e0144332. doi: 10.1371/journal.pone.0144332. eCollection 2015.
- Background: PubMed 29247235Strapazzon G, Paal P, Schweizer J, Falk M, Reuter B, Schenk K, Gatterer H, Grasegger K, Dal Cappello T, Malacrida S, Riess L, Brugger H. Effects of snow properties on humans breathing into an artificial air pocket - an experimental field study. Sci Rep. 2017 Dec 15;7(1):17675. doi: 10.1038/s41598-017-17960-4.
- Derived from this study: PubMed 35136116Roubik K, Sykora K, Sieger L, Ort V, Horakova L, Walzel S. Perlite is a suitable model material for experiments investigating breathing in high density snow. Sci Rep. 2022 Feb 8;12(1):2070. doi: 10.1038/s41598-022-06015-y.
- Work of Breathing into Snow in the Presence versus Absence of an Artificial Air Pocket Affects Hypoxia and Hypercapnia of a Victim Covered with Avalanche Snow: A Randomized Double Blind Crossover StudyLink provided by the sponsor.
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, PhD principal investigator
Czech Technical University in Prague, FBMI
2 sites 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 in people with Accident Caused by Snow Avalanche, run by Czech Technical University in Prague at 2 sites 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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 25 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
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 NCT03413878, which also lists 6 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 25 Feb 2021.