NCT03413878

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.

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
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

January 22, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 29, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

January 29, 2018

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2022

Completed
Last Updated

February 25, 2021

Status Verified

February 1, 2021

Enrollment Period

4.3 years

First QC Date

January 22, 2018

Last Update Submit

February 24, 2021

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 30 minute interval from the beginning of the breathing experiment

Study Arms (4)

Wet snow/Small air pocket

EXPERIMENTAL

Breathing in the simulated avalanche snow. Breathing into model of wet avalanche snow with a small air pocket

Other: Breathing in the simulated avalanche snow

Dry snow/Small air pocket

EXPERIMENTAL

Breathing in the simulated avalanche snow. Breathing into model of dry avalanche snow with a small air pocket

Other: Breathing in the simulated avalanche snow

Wet snow/Large air pocket

EXPERIMENTAL

Breathing in the simulated avalanche snow. Breathing into model of wet avalanche snow with a large air pocket

Other: Breathing in the simulated avalanche snow

Dry snow/Large air pocket

EXPERIMENTAL

Breathing in the simulated avalanche snow. Breathing into model of dry avalanche snow with a large air pocket

Other: Breathing in the simulated avalanche snow

Interventions

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

Dry snow/Large air pocketDry snow/Small air pocketWet snow/Large air pocketWet snow/Small air pocket

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 (2)

Czech Technical University, Faculty of Biomedical Engineering

Kladno, 272 01, Czechia

Location

Charles University, Czech Republic

Prague, 162 00, Czechia

Location

Related Publications (6)

  • 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.

    PMID: 12867313BACKGROUND
  • 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.

    PMID: 17325506BACKGROUND
  • 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.

    PMID: 10807386BACKGROUND
  • 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
  • Strapazzon G, Paal P, Schweizer J, Falk M, Reuter B, Schenk K, Gatterer H, Grasegger K, Dal Cappello T, Malacrida S, Riess L, Brugger H. Effects of snow properties on humans breathing into an artificial air pocket - an experimental field study. Sci Rep. 2017 Dec 15;7(1):17675. doi: 10.1038/s41598-017-17960-4.

    PMID: 29247235BACKGROUND
  • 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.

Related Links

MeSH Terms

Conditions

Hypercapnia

Interventions

Respiration

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Respiratory Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Officials

  • Karel Roubik, PhD

    Czech Technical University in Prague, FBMI

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 22, 2018

First Posted

January 29, 2018

Study Start

January 29, 2018

Primary Completion

May 20, 2022

Study Completion

May 20, 2022

Last Updated

February 25, 2021

Record last verified: 2021-02

Locations