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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04835545
Other study ID # DP-2021-Nemec
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date March 29, 2021
Est. completion date April 1, 2024

Study information

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

Clinical 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 13
Est. completion date April 1, 2024
Est. primary completion date April 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 30 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
extreme hypercapnia

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 (1)

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

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 7 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
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
Enrolling by invitation NCT05262894 - Evaluation of Gas Propagation in Snow During Breathing of Subjects Under Simulated Avalanche Snow N/A