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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05262894
Other study ID # 2022-Bradler
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date February 7, 2022
Est. completion date May 31, 2025

Study information

Verified date February 2022
Source Czech Technical University in Prague
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study is aimed at investigation of respiratory gases propagation in snow. The study involves volunteers breathing into the snow whereas concentrations of gases are measured at various positions in the snow.


Description:

The study is aimed at investigation of respiratory gases (oxygen and carbon dioxide) propagation in the simulated avalanche snow. The study involves volunteers breathing into the snow whereas concentrations of gases are measured at various positions in the snow. A special apparatus was created for sampling and measurement of gas concentrations and to assure stable geometry of the experiment required for data evaluation.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 50
Est. completion date May 31, 2025
Est. primary completion date May 31, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility 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

Study Design


Intervention

Other:
extreme hypercapnia induced by ventilation insufficiency
Re-breathing of gas by breathing into the simulated avalanche snow

Locations

Country Name City State
Czechia Czech Technical University, Faculty of Biomedical Engineering Kladno

Sponsors (1)

Lead Sponsor Collaborator
Czech Technical University in Prague

Country where clinical trial is conducted

Czechia, 

References & Publications (2)

Roubík 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. — View Citation

Roubik 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 20 minute interval from the beginning of the breathing experiment
See also
  Status Clinical Trial Phase
Recruiting NCT03911011 - Physiological Values When Breathing in an Air-pocket. Mountain Lab 2019 (ML2019) N/A
Active, not recruiting NCT04835545 - Work of Breathing Under Extreme Hypercapnia Induced by Ventilation Insufficiency N/A
Completed NCT02521272 - Hypercapnia and Gas Exchange Under the Avalanche Snow Model (HyperAvaSM) N/A
Active, not recruiting NCT03413878 - Snow Properties and Its Modeling for Studying Gas Exchange Under the Simulated Avalanche Snow N/A