- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03082105
Snow Physical Properties and Human Ventilatory Response
March 10, 2017 updated by: Institute of Mountain Emergency Medicine
Evaluation of Air Pocket Factors That Contribute to the Development of Hypoxia and Hypercapnia
Sufficient oxygenation is critical for completely buried avalanche victims to avoid life-threatening consequences during hypoxic exposure.
Snow contains a remarkable capacity to maintain air availability; it was suspected that the snow physical properties affect the development of hypoxia and hypercapnia.
The aim of this study was to evaluate the influence of different snow physical properties on the development of hypoxia and hypercapnia in subjects breathing into an artificial air pocket in snow.
Twelve male healthy subjects breathed through an airtight face-mask and 40cm tube into an artificial air pocket of 4L.
Every subject performed three tests on different days with varying snow characteristics.
Symptoms, gas and cardiovascular parameters were monitored up to 30min.
Tests were interrupted at SpO2 <75% (primary endpoint); or due to subjective symptoms like dyspnea, dizziness, and headache (i.e.
related to hypercapnia).
Snow density was assessed via standard methods and micro-computed tomography (CT) analysis, and permeability and penetration with the snow micro-penetrometer (SMP).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
-
-
Bz
-
Bolzano, Bz, Italy, 39100
- Institute of Mountain Emergency Medicine, Eurac Research
-
-
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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy volunteers with an age above 18yr-old, physically active.
- Volunteers have been informed and have signed consent.
Exclusion Criteria:
- Lack of consent.
- Chronic previous illness of the respiratory tract or of the cardiovascular system.
- Acute disease at or immediately prior to the test (eg, flu-like infection, fever of unknown origin).
- Eurac employees.
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: Winter snow
First test series breathing in dry snow in winter
|
Breathing in snow with different physical properties
|
Experimental: Intermediate snow
Second test series breathing in dry/wet snow in intermediate season
|
Breathing in snow with different physical properties
|
Experimental: Spring snow
Third test series breathing in very wet snow in spring
|
Breathing in snow with different physical properties
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
SpO2 (%)
Time Frame: Changes from baseline (measurement at 0min) -> snow-breathing phase (5min, 15min, and timepoint immediately before interruption of snow-breathing phase [max 30min]) -> 2.5min and 5min after snow-breathing phase
|
Continuous monitoring
|
Changes from baseline (measurement at 0min) -> snow-breathing phase (5min, 15min, and timepoint immediately before interruption of snow-breathing phase [max 30min]) -> 2.5min and 5min after snow-breathing phase
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
EtCO2 (mmHg)
Time Frame: Changes from baseline (measurement at 0min) -> snow-breathing phase (5min, 15min, and timepoint immediately before interruption of snow-breathing phase [max 30min]) -> 2.5min and 5min after snow-breathing phase
|
Continuous monitoring
|
Changes from baseline (measurement at 0min) -> snow-breathing phase (5min, 15min, and timepoint immediately before interruption of snow-breathing phase [max 30min]) -> 2.5min and 5min after snow-breathing phase
|
Cause of interruption
Time Frame: Timepoint immediately before interruption of snow-breathing phase (max 30min)
|
SpO2 <75% or subjectives symptoms due to hypercapnia (like dyspnea, dizziness, and headache)
|
Timepoint immediately before interruption of snow-breathing phase (max 30min)
|
VE (L/min)
Time Frame: Changes from baseline (measurement at 0min) -> snow-breathing phase (5min, 15min, and timepoint immediately before interruption of snow-breathing phase [max 30min]) -> 2.5min and 5min after snow-breathing phase
|
Continuous monitoring
|
Changes from baseline (measurement at 0min) -> snow-breathing phase (5min, 15min, and timepoint immediately before interruption of snow-breathing phase [max 30min]) -> 2.5min and 5min after snow-breathing phase
|
rSO2 (%)
Time Frame: Changes from baseline (measurement at 0min) -> snow-breathing phase (5min, 15min, and timepoint immediately before interruption of snow-breathing phase [max 30min]) -> 2.5min and 5min after snow-breathing phase
|
Continuous monitoring
|
Changes from baseline (measurement at 0min) -> snow-breathing phase (5min, 15min, and timepoint immediately before interruption of snow-breathing phase [max 30min]) -> 2.5min and 5min after snow-breathing phase
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Director: Giacomo Strapazzon, MD PhD, EURAC Research
- Study Director: Hermann Brugger, MD, EURAC Research
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.
- Haegeli P, Falk M, Brugger H, Etter HJ, Boyd J. Comparison of avalanche survival patterns in Canada and Switzerland. CMAJ. 2011 Apr 19;183(7):789-95. doi: 10.1503/cmaj.101435. Epub 2011 Mar 21.
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)
December 1, 2013
Primary Completion (Actual)
March 9, 2014
Study Completion (Actual)
March 9, 2014
Study Registration Dates
First Submitted
March 8, 2017
First Submitted That Met QC Criteria
March 10, 2017
First Posted (Actual)
March 17, 2017
Study Record Updates
Last Update Posted (Actual)
March 17, 2017
Last Update Submitted That Met QC Criteria
March 10, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- V/16/13
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
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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