Snow Properties and Its Modeling for Studying Gas Exchange Under the Simulated Avalanche Snow (SPAM)

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ClinicalTrials.gov Identifier: NCT03413878

Recruitment Status : Active, not recruiting

First Posted : January 29, 2018

Last Update Posted : February 25, 2021

Sponsor:

Collaborators:

Charles University, Czech Republic

Ministry of Defence and Armed Forces of the Czech Republic

Information provided by (Responsible Party):

Czech Technical University in Prague

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Accident Caused by Snow Avalanche	Other: Breathing in the simulated avalanche snow	Not Applicable

Detailed 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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	45 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Basic Science
Official Title:	Snow Properties and Its Modeling for Studying Gas Exchange Under the Simulated Avalanche Snow
Actual Study Start Date :	January 29, 2018
Estimated Primary Completion Date :	May 20, 2022
Estimated Study Completion Date :	May 20, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: Wet snow/Small air pocket Breathing in the simulated avalanche snow. Breathing into model of wet avalanche snow with a small air pocket	Other: Breathing in the simulated avalanche snow Breathing in the simulated wet or dry avalanche snow with a small or large air pocket
Experimental: Dry snow/Small air pocket Breathing in the simulated avalanche snow. Breathing into model of dry avalanche snow with a small air pocket	Other: Breathing in the simulated avalanche snow Breathing in the simulated wet or dry avalanche snow with a small or large air pocket
Experimental: Wet snow/Large air pocket Breathing in the simulated avalanche snow. Breathing into model of wet avalanche snow with a large air pocket	Other: Breathing in the simulated avalanche snow Breathing in the simulated wet or dry avalanche snow with a small or large air pocket
Experimental: Dry snow/Large air pocket Breathing in the simulated avalanche snow. Breathing into model of dry avalanche snow with a large air pocket	Other: Breathing in the simulated avalanche snow Breathing in the simulated wet or dry avalanche snow with a small or large air pocket

Outcome Measures

Primary Outcome Measures :

The length of breathing [ Time Frame: Continuously within 30 minute interval from the beginning of the breathing experiment ]
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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 50 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03413878

Locations

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Czechia
Czech Technical University, Faculty of Biomedical Engineering
Kladno, Czechia, 272 01
Charles University, Czech Republic
Prague, Czechia, 162 00

Sponsors and Collaborators

Czech Technical University in Prague

Charles University, Czech Republic

Ministry of Defence and Armed Forces of the Czech Republic

Investigators

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Principal Investigator:	Karel Roubik, PhD	Czech Technical University in Prague, FBMI

More Information

Additional Information:

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 This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

Publications:

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.

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.

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.

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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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Responsible Party:	Czech Technical University in Prague
ClinicalTrials.gov Identifier:	NCT03413878
Other Study ID Numbers:	VentRes-2018-01-KR
First Posted:	January 29, 2018 Key Record Dates
Last Update Posted:	February 25, 2021
Last Verified:	February 2021

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Czech Technical University in Prague:


snow avalanche hypercapnia work of breathing

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