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

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.

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.

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

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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