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

February 24, 2021 updated by: Czech Technical University in Prague
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.

Study Overview

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 Type

Interventional

Enrollment (Anticipated)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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
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
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
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
Breathing in the simulated wet or dry avalanche snow with a small or large air pocket

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Continuously within 30 minute interval from the beginning of the breathing experiment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 29, 2018

Primary Completion (Anticipated)

May 20, 2022

Study Completion (Anticipated)

May 20, 2022

Study Registration Dates

First Submitted

January 22, 2018

First Submitted That Met QC Criteria

January 22, 2018

First Posted (Actual)

January 29, 2018

Study Record Updates

Last Update Posted (Actual)

February 25, 2021

Last Update Submitted That Met QC Criteria

February 24, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • VentRes-2018-01-KR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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