NCT05262894

Brief Summary

The study is aimed at investigation of respiratory gases propagation in snow. The study involves volunteers breathing into the snow whereas concentrations of gases are measured at various positions in the 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
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2022

Longer than P75 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

February 7, 2022

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

February 21, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 2, 2022

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2025

Completed
Last Updated

March 2, 2022

Status Verified

February 1, 2022

Enrollment Period

3.3 years

First QC Date

February 21, 2022

Last Update Submit

March 1, 2022

Conditions

Keywords

snowavalanchehypercapniadiffusion

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 20 minute interval from the beginning of the breathing experiment

Study Arms (1)

Breathing in the snow

EXPERIMENTAL

Breathing in the snow using a specially designed apparatus and measuring the respiratory gases distribution in snow.

Other: extreme hypercapnia induced by ventilation insufficiency

Interventions

Re-breathing of gas by breathing into the simulated avalanche snow

Breathing in the snow

Eligibility Criteria

Age18 Years - 50 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 (2)

  • 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
  • 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.

    PMID: 35136116BACKGROUND

MeSH Terms

Conditions

Hypercapnia

Condition Hierarchy (Ancestors)

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

Study Officials

  • Karel Roubik, prof.

    Czech Technical University in Prague, Fac. of Biomedical Engineering

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2022

First Posted

March 2, 2022

Study Start

February 7, 2022

Primary Completion

May 31, 2025

Study Completion

May 31, 2025

Last Updated

March 2, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations