Accident Caused by Snow AvalancheNCT04835545
Work of Breathing Under Extreme Hypercapnia Induced by Ventilation Insufficiency
A study testing extreme hypercapnia induced by ventilation insufficiency 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 Work of Breathing of a person in simulated avalanche snow and consequent use of the measured data for judging which one of three simulated scenarios are alike while increasing hypercapnia in the simulated avalanche snow. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Accident Caused by Snow Avalanche
- What is being tested?
- extreme hypercapnia induced by ventilation insufficiency
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteCzechia
- Study dates
- 29 Mar 2021to 1 Apr 2024
- 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 30 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
1 site in 1 country.
Czechia1 site
Czech Technical University, Faculty of Biomedical Engineering
Kladno, 272 01
About this study
The aim of the study is to investigate Work of Breathing of a person in simulated avalanche snow and consequent use of the measured data for judging which one of three simulated scenarios are alike while increasing hypercapnia in the simulated avalanche snow.
Read the detailed description
The study is a part of a university diploma thesis aimed at studying physiological conditions and development of breathing parameters of a person breathing in the simulated avalanche snow. The Investigator is measuring Work of Breathing in three scenarios: a) 2L air pocket, b) 2L air pocket with resistance compensation and c) no air pocket. The investigator hypothesize that the Work of Breathing during compensation of air pocket will be alike with no air pocket scenario, thus proving significance of the resistance reduction for survival. The aim of the study is to investigate the effect of Work of Breathing on gas exchange in subjects breathing into the simulated avalanche snow scenarios.
- Conditions
- Accident Caused by Snow Avalanche
- Being tested
- extreme hypercapnia induced by ventilation insufficiency
- 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.
extreme hypercapnia induced by ventilation insufficiencyOther
extreme hypercapnia
| Study group | Role | What they receive |
|---|---|---|
| Wet Perlite, 2L air pocket | Experimental | Breathing in the simulated avalanche snow. Breathing into model of wet perlite with 2L air pocket Receives: Other: extreme hypercapnia induced by ventilation insufficiency |
| Wet Perlite 2L air pocket with resistance compensation | Experimental | Breathing in the simulated avalanche snow. Breathing into model of wet perlite 2L air pocket with resistance compensation Receives: Other: extreme hypercapnia induced by ventilation insufficiency |
| Wet Perlite, no air pocket | Experimental | Breathing in the simulated avalanche snow. Breathing into model of wet perlite with no air pocket Receives: Other: extreme hypercapnia induced by ventilation insufficiency |
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 up to 7 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 posted8 Apr 2021
- Study start29 Mar 2021
- Primary completion1 Apr 2024 (estimated)
- Study completion1 Apr 2024 (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 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Czech Technical University in Prague
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karel Roubík, PhD, Study director, Czech Technical University in Prague, FBMI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04835545
- Sponsor's protocol ID
- DP-2021-Nemec
- Status last verified
- Jul 2022
- First submitted
- 5 Apr 2021
- Last updated
- 22 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Roubik 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 26666523
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Work of Breathing Under Extreme Hypercapnia Induced by Ventilation Insufficiency
- ClinicalTrials.gov ID
- NCT04835545
- Acronym / sponsor ID
- DP-2021-Nemec
- Conditions
- Accident Caused by Snow Avalanche
- Keywords
- snow, avalanche, hypercapnia, work of breathing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Czech Technical University in PragueUniversity, hospital or other
- Study start
- 29 Mar 2021 (actual)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 8 Apr 2021 (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 Work of Breathing of a person in simulated avalanche snow and consequent use of the measured data for judging which one of three simulated scenarios are alike while increasing hypercapnia in the simulated avalanche snow.
Detailed description
The study is a part of a university diploma thesis aimed at studying physiological conditions and development of breathing parameters of a person breathing in the simulated avalanche snow. The Investigator is measuring Work of Breathing in three scenarios: a) 2L air pocket, b) 2L air pocket with resistance compensation and c) no air pocket. The investigator hypothesize that the Work of Breathing during compensation of air pocket will be alike with no air pocket scenario, thus proving significance of the resistance reduction for survival. The aim of the study is to investigate the effect of Work of Breathing on gas exchange in subjects breathing into the simulated avalanche snow scenarios.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Wet Perlite, 2L air pocket | Experimental | Other: extreme hypercapnia induced by ventilation insufficiencyBreathing in the simulated avalanche snow. Breathing into model of wet perlite with 2L air pocket |
| Wet Perlite 2L air pocket with resistance compensation | Experimental | Other: extreme hypercapnia induced by ventilation insufficiencyBreathing in the simulated avalanche snow. Breathing into model of wet perlite 2L air pocket with resistance compensation |
| Wet Perlite, no air pocket | Experimental | Other: extreme hypercapnia induced by ventilation insufficiencyBreathing in the simulated avalanche snow. Breathing into model of wet perlite with no air pocket |
Who may qualify
- Ages
- 18 to 30 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 |
|---|---|---|
| extreme hypercapnia induced by ventilation insufficiencyextreme hypercapnia | Other | Wet Perlite 2L air pocket with resistance compensation, Wet Perlite, 2L air pocket, Wet Perlite, no air pocket |
Primary outcome
The length of breathing
Time frame: Continuously within up to 7 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 22 Jul 2022.
- 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.
- Individual participant dataSharing planned: No
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 Roubík, PhD study director
Czech Technical University in Prague, FBMI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing extreme hypercapnia induced by ventilation insufficiency 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 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 22 Jul 2022. 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?
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 up to 7 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 NCT04835545, 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 22 Jul 2022.