ClinicalTrials.gg
Status unknownNCT03413878SPAMUpdated Feb 25, 2021

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

An interventional study of Breathing in the simulated avalanche snow in Accident Caused by Snow Avalanche, sponsored by Czech Technical University in Prague. Status unknown at 2 sites in Czechia. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-25.

Sponsored by Czech Technical University in Prague · Not applicable, Interventional, and Basic science

The sponsor has not verified this record recently (last verified Feb 2021), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
45
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Accident Caused by Snow Avalanche

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Keywords

  • snow
  • avalanche
  • hypercapnia
  • work of breathing
03

In context

Hypercapnia

156 studies on the registry are indexed under Hypercapnia; 31 are open to participants now.

This study's planned enrollment of 45 is above the median of 36 across 120 interventional studies indexed under Hypercapnia.

Browse Hypercapnia studies →

Lead sponsor

Czech Technical University in Prague is the lead sponsor of 36 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • healthy and fit volunteers, classified as The class I
  • without a smoking history

Exclusion criteria

Exclusion Criteria:

  • Tiffeneau Index less than 0.70
  • any cardiovascular or respiratory condition
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
45 participants (estimated)

Study arms

  • Experimental
    Wet snow/Small air pocket

    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

  • Experimental
    Dry snow/Small air pocket

    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

  • Experimental
    Wet snow/Large air pocket

    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

  • Experimental
    Dry snow/Large air pocket

    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

  • OtherBreathing in the simulated avalanche snow

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

06

What researchers measure

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.

    Time frame: Continuously within 30 minute interval from the beginning of the breathing experiment

07

Study locations

2 sites
  • Czech Technical University, Faculty of Biomedical Engineering
    Kladno, 272 01, Czechia
  • Charles University, Czech Republic
    Prague, 162 00, Czechia
08

References and documents

Publications

  • 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. PubMed 12867313 ↗
  • 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. PubMed 17325506 ↗
  • 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. PubMed 10807386 ↗
  • 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. PubMed 26666523 ↗
  • 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. PubMed 29247235 ↗
  • 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. PubMed 35136116 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2018 (actual). Primary completion is estimated for May 2022, 51 months after the start.

Of 50 non-industry interventional studies with no phase under Hypercapnia, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 32. This study's planned 51 months is above that.

Counting every sponsor, half of 54 studies reached it within 14 months; a quarter within 7 and three quarters within 32.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 22, 2018
First posted
Jan 29, 2018
StartActual
Jan 29, 2018
Primary completionEst.
May 20, 2022
CompletionEst.
May 20, 2022
Last update
Feb 25, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 25, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03413878
Lead sponsor
Czech Technical University in Prague
Collaborators
Charles University, Czech Republic, Ministry of Defence and Armed Forces of the Czech Republic
Responsible party
Sponsor
First posted
Jan 29, 2018
Start date
Jan 29, 2018
Primary completion
May 20, 2022 (estimated)
Completion
May 20, 2022 (estimated)
Last update
Feb 25, 2021

Study contacts

Karel Roubik, PhD
principal investigator · Czech Technical University in Prague, FBMI

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

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