NCT05779540

Efficacy and Pathophysiological Implications of a New Asphyxiation Delaying Device

A New Device to Delay Asphyxiation in Subjects Critically Buried in Avalanche Debris: Efficacy and Pathophysiological Implications

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (estimated)
• Sponsor: Institute of Mountain Emergency Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2023-02-15
• Primary completion: 2023-04-01
• Completion: 2024-02-01
• First posted: 2023-03-22
• Last updated: 2023-03-22

Locations

1 site across 1 country: Italy