Efficacy and Pathophysiological Implications of a New Asphyxiation Delaying Device

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-15

Study Completion Date

2024-02-29

Brief Summary

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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.

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Detailed Description

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Conditions

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Avalanche, Landslide, or Mudslide Asphyxia; Immersion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Intervention

Active Device

Group Type ACTIVE_COMPARATOR

Safeback SBX

Intervention Type DEVICE

The intervention consists in the test of the active device.

Control

Sham Device

Group Type SHAM_COMPARATOR

Sham device

Intervention Type DEVICE

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

Interventions

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Safeback SBX

The intervention consists in the test of the active device.

Intervention Type DEVICE

Sham device

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

\- healthy ASA I subjects

Exclusion Criteria

* ASA class II or higher
* chronic high degree cardiovascular or pulmonary disease
* claustrophobia
* psychiatric or neurological disease
* long-term medication
* pregnant woman
* no informed consent
* history of fever or serious cough in the past two weeks
* current Covid-19 symptoms or recently tested positive for Covid-19
* body temperature ≥ 37.5°on test days.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes