NCT04835545

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 29, 2021

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

April 5, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 8, 2021

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

July 22, 2022

Status Verified

July 1, 2022

Enrollment Period

3 years

First QC Date

April 5, 2021

Last Update Submit

July 20, 2022

Conditions

Keywords

snowavalanchehypercapniawork of breathing

Outcome Measures

Primary Outcomes (1)

  • 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 up to 7 minute interval from the beginning of the breathing experiment

Study Arms (3)

Wet Perlite, 2L air pocket

EXPERIMENTAL

Breathing in the simulated avalanche snow. Breathing into model of wet perlite with 2L air pocket

Other: extreme hypercapnia induced by ventilation insufficiency

Wet Perlite 2L air pocket with resistance compensation

EXPERIMENTAL

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

Wet Perlite, no air pocket

EXPERIMENTAL

Breathing in the simulated avalanche snow. Breathing into model of wet perlite with no air pocket

Other: extreme hypercapnia induced by ventilation insufficiency

Interventions

extreme hypercapnia

Wet Perlite 2L air pocket with resistance compensationWet Perlite, 2L air pocketWet Perlite, no air pocket

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy and fit volunteers, classified as The American Society of Anesthesiologists class I
  • without a smoking history

You may not qualify if:

  • Tiffeneau Index less than 0.70
  • any cardiovascular or respiratory condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Czech Technical University, Faculty of Biomedical Engineering

Kladno, 272 01, Czechia

Location

Related Publications (1)

  • Roubik 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.

    PMID: 26666523BACKGROUND

MeSH Terms

Conditions

Hypercapnia

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Karel Roubík, PhD

    Czech Technical University in Prague, FBMI

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2021

First Posted

April 8, 2021

Study Start

March 29, 2021

Primary Completion

April 1, 2024

Study Completion

April 1, 2024

Last Updated

July 22, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations