NCT03082105

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 9, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 9, 2014

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

March 8, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 17, 2017

Completed
Last Updated

March 17, 2017

Status Verified

March 1, 2017

Enrollment Period

3 months

First QC Date

March 8, 2017

Last Update Submit

March 10, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • SpO2 (%)

    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 Outcomes (4)

  • EtCO2 (mmHg)

    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

    Timepoint immediately before interruption of snow-breathing phase (max 30min)

  • VE (L/min)

    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 (%)

    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

Study Arms (3)

Winter snow

EXPERIMENTAL

First test series breathing in dry snow in winter

Other: Breathing in snow

Intermediate snow

EXPERIMENTAL

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

Other: Breathing in snow

Spring snow

EXPERIMENTAL

Third test series breathing in very wet snow in spring

Other: Breathing in snow

Interventions

Breathing in snow with different physical properties

Intermediate snowSpring snowWinter snow

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy volunteers with an age above 18yr-old, physically active.
  • Volunteers have been informed and have signed consent.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Mountain Emergency Medicine, Eurac Research

Bolzano, Bz, 39100, Italy

Location

Related Publications (2)

  • 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.

    PMID: 12867313BACKGROUND
  • 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.

    PMID: 21422139BACKGROUND

MeSH Terms

Conditions

Respiratory Insufficiency

Interventions

RespirationSnow

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Respiratory Physiological PhenomenaCirculatory and Respiratory Physiological PhenomenaClimatic ProcessesEcological and Environmental PhenomenaBiological PhenomenaWeatherAtmosphereEnvironmentMeteorological ConceptsEnvironment and Public Health

Study Officials

  • Giacomo Strapazzon, MD PhD

    Eurac Research

    STUDY DIRECTOR
  • Hermann Brugger, MD

    Eurac Research

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2017

First Posted

March 17, 2017

Study Start

December 1, 2013

Primary Completion

March 9, 2014

Study Completion

March 9, 2014

Last Updated

March 17, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations