Work of Breathing Under Extreme Hypercapnia Induced by Ventilation Insufficiency
1 other identifier
interventional
13
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 29, 2021
CompletedFirst Submitted
Initial submission to the registry
April 5, 2021
CompletedFirst Posted
Study publicly available on registry
April 8, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2024
CompletedJuly 22, 2022
July 1, 2022
3 years
April 5, 2021
July 20, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Continuously within up to 7 minute interval from the beginning of the breathing experiment
Study Arms (3)
Wet Perlite, 2L air pocket
EXPERIMENTALBreathing in the simulated avalanche snow. Breathing into model of wet perlite with 2L air pocket
Wet Perlite 2L air pocket with resistance compensation
EXPERIMENTALBreathing in the simulated avalanche snow. Breathing into model of wet perlite 2L air pocket with resistance compensation
Wet Perlite, no air pocket
EXPERIMENTALBreathing in the simulated avalanche snow. Breathing into model of wet perlite with no air pocket
Interventions
extreme hypercapnia
Eligibility Criteria
You may qualify if:
- healthy and fit volunteers, classified as The American Society of Anesthesiologists class I
- without a smoking history
You may not qualify if:
- Tiffeneau Index less than 0.70
- any cardiovascular or respiratory condition
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Czech Technical University, Faculty of Biomedical Engineering
Kladno, 272 01, Czechia
Related Publications (1)
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.
PMID: 26666523BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Karel Roubík, PhD
Czech Technical University in Prague, FBMI
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 5, 2021
First Posted
April 8, 2021
Study Start
March 29, 2021
Primary Completion
April 1, 2024
Study Completion
April 1, 2024
Last Updated
July 22, 2022
Record last verified: 2022-07
Data Sharing
- IPD Sharing
- Will not share