Work of Breathing Under Extreme Hypercapnia Induced by Ventilation Insufficiency
Primary Purpose
Accident Caused by Snow Avalanche
Status
Active
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
extreme hypercapnia induced by ventilation insufficiency
Sponsored by
About this trial
This is an interventional basic science trial for Accident Caused by Snow Avalanche focused on measuring snow, avalanche, hypercapnia, work of breathing
Eligibility Criteria
Inclusion Criteria:
- healthy and fit volunteers, classified as The American Society of Anesthesiologists class I
- without a smoking history
Exclusion Criteria:
- Tiffeneau Index less than 0.70
- any cardiovascular or respiratory condition
Sites / Locations
- Czech Technical University, Faculty of Biomedical Engineering
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Wet Perlite, 2L air pocket
Wet Perlite 2L air pocket with resistance compensation
Wet Perlite, no air pocket
Arm Description
Breathing in the simulated avalanche snow. Breathing into model of wet perlite with 2L air pocket
Breathing in the simulated avalanche snow. Breathing into model of wet perlite 2L air pocket with resistance compensation
Breathing in the simulated avalanche snow. Breathing into model of wet perlite with no air pocket
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04835545
First Posted
April 5, 2021
Last Updated
July 20, 2022
Sponsor
Czech Technical University in Prague
1. Study Identification
Unique Protocol Identification Number
NCT04835545
Brief Title
Work of Breathing Under Extreme Hypercapnia Induced by Ventilation Insufficiency
Official Title
Work of Breathing Under Extreme Hypercapnia Induced by Ventilation Insufficiency
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 29, 2021 (Actual)
Primary Completion Date
April 1, 2024 (Anticipated)
Study Completion Date
April 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Czech Technical University in Prague
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Accident Caused by Snow Avalanche
Keywords
snow, avalanche, hypercapnia, work of breathing
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Wet Perlite, 2L air pocket
Arm Type
Experimental
Arm Description
Breathing in the simulated avalanche snow. Breathing into model of wet perlite with 2L air pocket
Arm Title
Wet Perlite 2L air pocket with resistance compensation
Arm Type
Experimental
Arm Description
Breathing in the simulated avalanche snow. Breathing into model of wet perlite 2L air pocket with resistance compensation
Arm Title
Wet Perlite, no air pocket
Arm Type
Experimental
Arm Description
Breathing in the simulated avalanche snow. Breathing into model of wet perlite with no air pocket
Intervention Type
Other
Intervention Name(s)
extreme hypercapnia induced by ventilation insufficiency
Intervention Description
extreme hypercapnia
Primary Outcome Measure Information:
Title
The length of breathing
Description
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.
Time Frame
Continuously within up to 7 minute interval from the beginning of the breathing experiment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
healthy and fit volunteers, classified as The American Society of Anesthesiologists class I
without a smoking history
Exclusion Criteria:
Tiffeneau Index less than 0.70
any cardiovascular or respiratory condition
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karel Roubík, PhD
Organizational Affiliation
Czech Technical University in Prague, FBMI
Official's Role
Study Director
Facility Information:
Facility Name
Czech Technical University, Faculty of Biomedical Engineering
City
Kladno
ZIP/Postal Code
272 01
Country
Czechia
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26666523
Citation
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.
Results Reference
background
Learn more about this trial
Work of Breathing Under Extreme Hypercapnia Induced by Ventilation Insufficiency
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