- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03413878
Snow Properties and Its Modeling for Studying Gas Exchange Under the Simulated Avalanche Snow (SPAM)
February 24, 2021 updated by: Czech Technical University in Prague
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
45
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
-
-
-
Kladno, Czechia, 272 01
- Czech Technical University, Faculty of Biomedical Engineering
-
Prague, Czechia, 162 00
- Charles University, Czech Republic
-
-
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 50 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: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Wet snow/Small air pocket
Breathing in the simulated avalanche snow.
Breathing into model of wet avalanche snow with a small air pocket
|
Breathing in the simulated wet or dry avalanche snow with a small or large air pocket
|
|
Experimental: Dry snow/Small air pocket
Breathing in the simulated avalanche snow.
Breathing into model of dry avalanche snow with a small air pocket
|
Breathing in the simulated wet or dry avalanche snow with a small or large air pocket
|
|
Experimental: Wet snow/Large air pocket
Breathing in the simulated avalanche snow.
Breathing into model of wet avalanche snow with a large air pocket
|
Breathing in the simulated wet or dry avalanche snow with a small or large air pocket
|
|
Experimental: Dry snow/Large air pocket
Breathing in the simulated avalanche snow.
Breathing into model of dry avalanche snow with a large air pocket
|
Breathing in the simulated wet or dry avalanche snow with a small or large air pocket
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The length of breathing
Time Frame: Continuously within 30 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 30 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.
Collaborators
Investigators
- Principal Investigator: Karel Roubik, 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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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)
January 29, 2018
Primary Completion (Anticipated)
May 20, 2022
Study Completion (Anticipated)
May 20, 2022
Study Registration Dates
First Submitted
January 22, 2018
First Submitted That Met QC Criteria
January 22, 2018
First Posted (Actual)
January 29, 2018
Study Record Updates
Last Update Posted (Actual)
February 25, 2021
Last Update Submitted That Met QC Criteria
February 24, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- VentRes-2018-01-KR
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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