Independent Medical Trial: Full Burial Testing

Eurac Research has conducted an independent study to test the validity of Safeback SBX to increase the survivability of avalanche burial.

During the product's development, Safeback contacted Eurac to scientifically test SBX and confirm whether it can significantly extend survival time in the snow.

As a part of the trial, full burial tests were carried out on 30 volunteers who were among the first to experience complete snow burial with the system activated.

The following text is taken from Eurac’s published study design on Good Clinical Practice Network.

Study Details

Background

Survival of fully buried avalanche victims depends in significant part on a triad of hypoxia, hypercapnia, and hypothermia and therefore decreases rapidly after complete burial. Aside from 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 breathe 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 developed a new non-medical device using an innovative functional principle. Safeback SBX should make it possible to prevent asphyxia by delivering fresh air to the breathing area. Safeback claims to achieve a prolongation of survival beyond 60 minutes, giving companion rescuers as well as professional rescue teams more time to get access to the victim. Technical tests conducted by the company already provide promising results regarding the general functionality. However, this study is needed to provide scientific evidence of the effectiveness and influence on human physiologic parameters while buried in snow debris in realistic conditions.

Methods

A randomized parallel assignment experimental field study enrolled 30 healthy subjects in Bolzano, Italy in March 2023. To rule out a placebo effect, the test subjects were divided into two groups without telling them which group they belonged to: one control group was assigned a dummy device (which did not work but made realistic sounds), and the other group a working device. Subjects were completely buried until they reached one of two thresholds: 60-minute burial, or Blood Oxygen Saturation (SpO2) dropping below 75%.

Study Measures

Total Burial Time Physiological Effects: - Blood Oxygen Saturation (SpO2) - End tidal CO2 (EtCO2) - Minute Ventalation (VE) - Cerebral Regional Oxygen Saturation (rSO2) - NASA Task Workload Index (NASA-TLX) - Reactive Oxygen Species (ROS) - Total Antioxidant Capacity (TAC)

Results

In March 2023, Eurac stated that the study’s results will be "ready in the fall of 2023". Since then, they have presented pretest results to all commissions at ICAR 2023, but under embargo. Complete results will be published in a peer-reviewed medical journal, so there is no fixed date when we know the results will be published.

Read Eurac's account of the study, including more photos and video

“We will still publish the results of the study as per scientific research practice, even in a case where they prove that the device does not work so well.” - Giacomo Strapazzon, director of the Institute of Mountain Emergency Medicine at Eurac and responsible for the study.

“Regardless of the results of this study, no device can ever guarantee survival under an avalanche. The most important thing is to prevent exposure, thanks to avalanche forecasting and warning services or the training of companions on self-rescue techniques. If the device we are testing works well, those who go to the mountains will have an extra tool to extend the time in which the rescue is still effective.” - Hermann Brugger, an emergency doctor at Eurac Research.