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Hypercapnia and Gas Exchange Under the Avalanche Snow Model (HyperAvaSM) (HyperAvaSM)

Primary Purpose

Accident Caused by Snow Avalanche

Status
Completed
Phase
Not Applicable
Locations
Czech Republic
Study Type
Interventional
Intervention
Breathing in the simulated avalanche snow.
air pocket
Sponsored by
Czech Technical University in Prague
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Accident Caused by Snow Avalanche

Eligibility Criteria

20 Years - 30 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Participants were volunteers from the Czech Army forces, studying at the Military Department of the Faculty of Physical Education and Sport, Charles University in Prague. All subjects were healthy and fit, classified as ASA I, all without a smoking history. The volunteers were highly motivated to participate in the experiment. The entrance examination, completed before the start of the study, included these tests: electrocardiography, blood pressure, spirometry, and assessment of the health conditions and family anamnesis by a physician with a specialty in anesthesia and critical care.

Exclusion Criteria:

  • The exclusion criteria were Tiffeneau Index less than 0.70 and any cardiovascular or respiratory condition.

Sites / Locations

  • Charles University, Czech Republic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

air pocket

Arm Description

Breathing in the simulated avalanche snow.

Outcomes

Primary Outcome Measures

The length of breathing
Time to termination of the breathing experiment due to the decision of the subject, or determined by high End-Tidal CO2 value or by the order by the clinician assessing the health status of the subjects.

Secondary Outcome Measures

Full Information

First Posted
August 10, 2015
Last Updated
August 11, 2015
Sponsor
Czech Technical University in Prague
Collaborators
Charles University, Czech Republic
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1. Study Identification

Unique Protocol Identification Number
NCT02521272
Brief Title
Hypercapnia and Gas Exchange Under the Avalanche Snow Model (HyperAvaSM)
Acronym
HyperAvaSM
Official Title
Hypercapnia and Gas Exchange Under the Simulated Avalanche Snow
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Czech Technical University in Prague
Collaborators
Charles University, Czech Republic

4. Oversight

Data Monitoring Committee
No

5. 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.
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 and to test, whether it is possible to breathe with zero air pocket.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Accident Caused by Snow Avalanche

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
air pocket
Arm Type
Experimental
Arm Description
Breathing in the simulated avalanche snow.
Intervention Type
Other
Intervention Name(s)
Breathing in the simulated avalanche snow.
Intervention Description
Breathing in the simulated avalanche snow with zero air pocket and one-liter air pocket.
Intervention Type
Device
Intervention Name(s)
air pocket
Intervention Description
Zero air pocket or one-liter air pocket in the snow.
Primary Outcome Measure Information:
Title
The length of breathing
Description
Time to termination of the breathing experiment due to the decision of the subject, or determined by high End-Tidal CO2 value or by the order by the clinician assessing the health status of the subjects.
Time Frame
Continuously within 30 minute interval from the beginning of the breathing experiment

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Participants were volunteers from the Czech Army forces, studying at the Military Department of the Faculty of Physical Education and Sport, Charles University in Prague. All subjects were healthy and fit, classified as ASA I, all without a smoking history. The volunteers were highly motivated to participate in the experiment. The entrance examination, completed before the start of the study, included these tests: electrocardiography, blood pressure, spirometry, and assessment of the health conditions and family anamnesis by a physician with a specialty in anesthesia and critical care. Exclusion Criteria: The exclusion criteria were Tiffeneau Index less than 0.70 and any cardiovascular or respiratory condition.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karel Roubik, prof., Ph.D.
Organizational Affiliation
Czech Technical University in Prague
Official's Role
Study Director
Facility Information:
Facility Name
Charles University, Czech Republic
City
Prague
ZIP/Postal Code
162 00
Country
Czech Republic

12. IPD Sharing Statement

Citations:
PubMed Identifier
12867313
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. doi: 10.1016/s0300-9572(03)00113-8.
Results Reference
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PubMed Identifier
17325506
Citation
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. doi: 10.1097/00000542-200703000-00012.
Results Reference
background
PubMed Identifier
10807386
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. doi: 10.1001/jama.283.17.2266.
Results Reference
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Hypercapnia and Gas Exchange Under the Avalanche Snow Model (HyperAvaSM)

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