Work of Breathing Under Extreme Hypercapnia Induced by Ventilation Insufficiency

July 20, 2022 updated by: Czech Technical University in Prague
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

13

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

  • Czechia
      • Kladno, Czechia, 272 01
        • Czech Technical University, Faculty of Biomedical Engineering

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 30 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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Wet Perlite, 2L air pocket
Breathing in the simulated avalanche snow. Breathing into model of wet perlite with 2L air pocket
Other: extreme hypercapnia induced by ventilation insufficiency
extreme hypercapnia
Experimental: Wet Perlite 2L air pocket with resistance compensation
Breathing in the simulated avalanche snow. Breathing into model of wet perlite 2L air pocket with resistance compensation
Other: extreme hypercapnia induced by ventilation insufficiency
extreme hypercapnia
Experimental: Wet Perlite, no air pocket
Breathing in the simulated avalanche snow. Breathing into model of wet perlite with no air pocket
Other: extreme hypercapnia induced by ventilation insufficiency
extreme hypercapnia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The length of breathing
Time Frame: Continuously within up to 7 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 up to 7 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.

Sponsor

Czech Technical University in Prague

Investigators

  • Study Director: Karel Roubík, 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)

March 29, 2021

Primary Completion (Anticipated)

April 1, 2024

Study Completion (Anticipated)

April 1, 2024

Study Registration Dates

First Submitted

April 5, 2021

First Submitted That Met QC Criteria

April 5, 2021

First Posted (Actual)

April 8, 2021

Study Record Updates

Last Update Posted (Actual)

July 22, 2022

Last Update Submitted That Met QC Criteria

July 20, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DP-2021-Nemec

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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