- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02521272
Hypercapnia and Gas Exchange Under the Avalanche Snow Model (HyperAvaSM) (HyperAvaSM)
August 11, 2015 updated by: Czech Technical University in Prague
Hypercapnia and Gas Exchange Under the Simulated Avalanche Snow
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
Completed
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 and to test, whether it is possible to breathe with zero air pocket.
Study Type
Interventional
Enrollment (Actual)
12
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
-
-
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Prague, Czech Republic, 162 00
- Charles University, Czech Republic
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-
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
20 years to 30 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Participants were volunteers from the Czech Army forces, studying at the Military Department of the Faculty of Physical Education and Sport, Charles University in Prague. All subjects were healthy and fit, classified as ASA I, all without a smoking history. The volunteers were highly motivated to participate in the experiment. The entrance examination, completed before the start of the study, included these tests: electrocardiography, blood pressure, spirometry, and assessment of the health conditions and family anamnesis by a physician with a specialty in anesthesia and critical care.
Exclusion Criteria:
- The exclusion criteria were Tiffeneau Index less than 0.70 and 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: NA
- Interventional Model: SINGLE_GROUP
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: air pocket
Breathing in the simulated avalanche snow.
|
Breathing in the simulated avalanche snow with zero air pocket and one-liter air pocket.
Zero air pocket or one-liter air pocket in the snow.
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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 subject, or determined by high End-Tidal CO2 value or by the order by the clinician assessing the health status of the subjects.
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Continuously within 30 minute interval from the beginning of the breathing experiment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
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.
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
March 1, 2012
Primary Completion (ACTUAL)
March 1, 2012
Study Completion (ACTUAL)
March 1, 2012
Study Registration Dates
First Submitted
August 10, 2015
First Submitted That Met QC Criteria
August 11, 2015
First Posted (ESTIMATE)
August 13, 2015
Study Record Updates
Last Update Posted (ESTIMATE)
August 13, 2015
Last Update Submitted That Met QC Criteria
August 11, 2015
Last Verified
August 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VentRes-2015-01-KR
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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