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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03413878
Other study ID # VentRes-2018-01-KR
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date January 29, 2018
Est. completion date May 20, 2022

Study information

Verified date February 2021
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 respiratory parameters of a person in the simulated avalanche snow and consequent use of the measured data for development of a mathematical-physical model of breathing during increasing hypercapnia in the avalanche.


Description:

The study is a part of a university research project aimed at studying physiological conditions and development of breathing parameters of a person breathing in the simulated avalanche snow. Presence of an air pocket and its size play an important role in survival of victims buried in the avalanche snow. Even small air pockets facilitate breathing, yet they do not provide a significant amount of fresh air for breathing. The investigators hypothesize that the size of the air pocket significantly affects the airflow resistance and work of breathing. The aim of the study is to investigate the effect of the air pocket volume on gas exchange and work of breathing in subjects breathing into the simulated avalanche snow.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 45
Est. completion date May 20, 2022
Est. primary completion date May 20, 2022
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


Related Conditions & MeSH terms


Intervention

Other:
Breathing in the simulated avalanche snow
Breathing in the simulated wet or dry avalanche snow with a small or large air pocket

Locations

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

Sponsors (3)

Lead Sponsor Collaborator
Czech Technical University in Prague Charles University, Czech Republic, Ministry of Defence and Armed Forces of the Czech Republic

Country where clinical trial is conducted

Czechia, 

References & Publications (5)

Bellani G, Patroniti N, Weismann D, Galbiati L, Curto F, Foti G, Pesenti A. Measurement of pressure-time product during spontaneous assisted breathing by rapid interrupter technique. Anesthesiology. 2007 Mar;106(3):484-90. — View Citation

Brugger H, Sumann G, Meister R, Adler-Kastner L, Mair P, Gunga HC, Schobersberger W, Falk M. Hypoxia and hypercapnia during respiration into an artificial air pocket in snow: implications for avalanche survival. Resuscitation. 2003 Jul;58(1):81-8. — View Citation

Grissom CK, Radwin MI, Harmston CH, Hirshberg EL, Crowley TJ. Respiration during snow burial using an artificial air pocket. JAMA. 2000 May 3;283(17):2266-71. — View Citation

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

Strapazzon G, Paal P, Schweizer J, Falk M, Reuter B, Schenk K, Gatterer H, Grasegger K, Dal Cappello T, Malacrida S, Riess L, Brugger H. Effects of snow properties on humans breathing into an artificial air pocket - an experimental field study. Sci Rep. 2017 Dec 15;7(1):17675. doi: 10.1038/s41598-017-17960-4. — 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 30 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
Enrolling by invitation NCT05262894 - Evaluation of Gas Propagation in Snow During Breathing of Subjects Under Simulated Avalanche Snow N/A