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Efficacy and Pathophysiological Implications of a New Asphyxiation Delaying Device

NCT05779540 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2023-03-22

No results posted yet for this study

Summary

Survival of fully buried avalanche victims depends in major part on a triad of hypoxia, hypercapnia, and hypothermia and therefore decreases rapidly after complete burial. Besides optimizing companion rescue, which still today and even by trained people often takes more than 15 minutes to the extraction of an avalanche victim, prolonging the ability to breath after critical avalanche burial increases survival probability by giving rescuers more time to find and unbury avalanche victims. Based on previous research, the Norwegian company Safeback SE (Bergen, Norway) developed a new non-medical device using an innovative functional principle. The device, called the Safeback SBX (Safeback SE, Bergen, Norway), should make it possible to prevent asphyxia by delivering fresh air to the air pocket. Company claims to achieve a prolongation of survival up to over 60 minutes, giving companion rescuers as well as professional rescue teams more time to get access to the victim. Technical tests conducted by the developing company already provided some promising results regarding the general functioning. However, this study is needed to provide the scientific evidence of the effectiveness and influence on physiologic parameters buried in snow debris humans under realistic conditions.

Conditions

  • Avalanche, Landslide, or Mudslide
  • Asphyxia; Immersion

Interventions

DEVICE

Safeback SBX

The intervention consists in the test of the active device.

DEVICE

Sham device

The intervention consists in a similar device to that emits same noise but does not deliver airflow.

Sponsors & Collaborators

  • Medical University Innsbruck

    collaborator OTHER

  • Haukeland University Hospital

    collaborator OTHER

  • Institute of Mountain Emergency Medicine

    lead OTHER

Principal Investigators

  • Giacomo Strapazzon, Dr. · Institute of Mountain Emergency Medicine, Eurac Research

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-02-15
Primary Completion
2023-04-30
Completion
2024-02-29

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05779540 on ClinicalTrials.gov