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Snow Physical Properties and Human Ventilatory Response

Primary Purpose

Hypoxic Respiratory Failure, Hypercapnic Respiratory Failure, Avalanche Burial

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Breathing in snow
Sponsored by
Institute of Mountain Emergency Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hypoxic Respiratory Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Institute of Mountain Emergency Medicine, Eurac Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Winter snow

Intermediate snow

Spring snow

Arm Description

First test series breathing in dry snow in winter

Second test series breathing in dry/wet snow in intermediate season

Third test series breathing in very wet snow in spring

Outcomes

Primary Outcome Measures

SpO2 (%)
Continuous monitoring

Secondary Outcome Measures

EtCO2 (mmHg)
Continuous monitoring
Cause of interruption
SpO2 <75% or subjectives symptoms due to hypercapnia (like dyspnea, dizziness, and headache)
VE (L/min)
Continuous monitoring
rSO2 (%)
Continuous monitoring

Full Information

First Posted
March 8, 2017
Last Updated
March 10, 2017
Sponsor
Institute of Mountain Emergency Medicine
Collaborators
Medical University Innsbruck
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1. Study Identification

Unique Protocol Identification Number
NCT03082105
Brief Title
Snow Physical Properties and Human Ventilatory Response
Official Title
Evaluation of Air Pocket Factors That Contribute to the Development of Hypoxia and Hypercapnia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
December 1, 2013 (Actual)
Primary Completion Date
March 9, 2014 (Actual)
Study Completion Date
March 9, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Mountain Emergency Medicine
Collaborators
Medical University Innsbruck

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxic Respiratory Failure, Hypercapnic Respiratory Failure, Avalanche Burial, Snow Physical Properties

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Winter snow
Arm Type
Experimental
Arm Description
First test series breathing in dry snow in winter
Arm Title
Intermediate snow
Arm Type
Experimental
Arm Description
Second test series breathing in dry/wet snow in intermediate season
Arm Title
Spring snow
Arm Type
Experimental
Arm Description
Third test series breathing in very wet snow in spring
Intervention Type
Other
Intervention Name(s)
Breathing in snow
Intervention Description
Breathing in snow with different physical properties
Primary Outcome Measure Information:
Title
SpO2 (%)
Description
Continuous monitoring
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
Secondary Outcome Measure Information:
Title
EtCO2 (mmHg)
Description
Continuous monitoring
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
Title
Cause of interruption
Description
SpO2 <75% or subjectives symptoms due to hypercapnia (like dyspnea, dizziness, and headache)
Time Frame
Timepoint immediately before interruption of snow-breathing phase (max 30min)
Title
VE (L/min)
Description
Continuous monitoring
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
Title
rSO2 (%)
Description
Continuous monitoring
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giacomo Strapazzon, MD PhD
Organizational Affiliation
Eurac Research
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Hermann Brugger, MD
Organizational Affiliation
Eurac Research
Official's Role
Study Director
Facility Information:
Facility Name
Institute of Mountain Emergency Medicine, Eurac Research
City
Bolzano
State/Province
Bz
ZIP/Postal Code
39100
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
12867313
Citation
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.
Results Reference
background
PubMed Identifier
21422139
Citation
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.
Results Reference
background

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Snow Physical Properties and Human Ventilatory Response

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