Efficacy and Pathophysiological Implications of a New Asphyxiation Delaying Device (SAFEBACK)

Institute of Mountain Emergency Medicine

Status: Enrolling

Conditions: Avalanche, Landslide, or Mudslide; Asphyxia; Immersion

Treatments: Device: Sham device; Device: Safeback SBX

Study type: Interventional

Funder types: Other

Identifiers

NCT05779540

SB1

Details and patient eligibility

About

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.

Enrollment: 26 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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26 participants in 2 patient groups

Intervention

Active Comparator group

Description:

Active Device

Treatment:

Device: Safeback SBX

Control

Sham Comparator group

Description:

Sham Device

Treatment:

Device: Sham device