NCT02521272

Brief Summary

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.

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 Mar 2012

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

March 1, 2012

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

August 10, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 13, 2015

Completed
Last Updated

August 13, 2015

Status Verified

August 1, 2015

Enrollment Period

Same day

First QC Date

August 10, 2015

Last Update Submit

August 11, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • The length of breathing

    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.

    Continuously within 30 minute interval from the beginning of the breathing experiment

Study Arms (1)

air pocket

EXPERIMENTAL

Breathing in the simulated avalanche snow.

Other: Breathing in the simulated avalanche snow.Device: air pocket

Interventions

Breathing in the simulated avalanche snow with zero air pocket and one-liter air pocket.

air pocket

Zero air pocket or one-liter air pocket in the snow.

air pocket

Eligibility Criteria

Age20 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charles University, Czech Republic

Prague, 162 00, Czechia

Location

Related Publications (3)

  • 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
  • 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.

    PMID: 17325506BACKGROUND
  • 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.

    PMID: 10807386BACKGROUND

MeSH Terms

Interventions

Respiration

Intervention Hierarchy (Ancestors)

Respiratory Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Officials

  • Karel Roubik, prof., Ph.D.

    Czech Technical University in Prague

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

August 10, 2015

First Posted

August 13, 2015

Study Start

March 1, 2012

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

August 13, 2015

Record last verified: 2015-08

Locations