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| Name | Class |
|---|---|
| Medical University Innsbruck | OTHER |
| Haukeland University Hospital | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Active Comparator | Active Device |
|
| Control | Sham Comparator | Sham Device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Safeback SBX | Device | The intervention consists in the test of the active device. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Time limit | Reaching a predefined time limit (min) | From baseline up to 60 minutes |
| Physiological threshold | Time to reach a SpO2 threshold up to <75% (min) | From baseline up to 60 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| End-tidal CO2 (EtCO2) | Changes in EtCO2 (mmHg) | Changes from baseline (measurement at 0 min) -> snow-breathing phase (5min, 15min, and timepoint immediately before interruption [up to 60 min) (countinuous monitoring) |
| Minute ventilation (VE) |
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Inclusion Criteria:
- healthy ASA I subjects
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Frederik Eisendle, Dr. | Contact | +39 0471 055 759 | frederik.eisendl@eurac.edu |
| Name | Affiliation | Role |
|---|---|---|
| Giacomo Strapazzon, Dr. | Institute of Mountain Emergency Medicine, Eurac Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Mountain Emergency Medicine, Eurac Research | Recruiting | Bolzano | Bz | 39100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7969398 | Background | Falk M, Brugger H, Adler-Kastner L. Avalanche survival chances. Nature. 1994 Mar 3;368(6466):21. doi: 10.1038/368021a0. No abstract available. | |
| 35063621 | Background | Wik L, Brattebo G, Osteras O, Assmus J, Irusta U, Aramendi E, Mydske S, Skaalhegg T, Skaiaa SC, Thomassen O. Physiological effects of providing supplemental air for avalanche victims. A randomised trial. Resuscitation. 2022 Mar;172:38-46. doi: 10.1016/j.resuscitation.2022.01.007. Epub 2022 Jan 19. |
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| ID | Term |
|---|---|
| D001237 | Asphyxia |
| D006323 | Heart Arrest |
| ID | Term |
|---|---|
| D003643 | Death |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014947 | Wounds and Injuries |
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| Sham device |
| Device |
The intervention consists in a similar device to that emits same noise but does not deliver airflow. |
|
Changes in VE (L/min)
| Changes from baseline (measurement at 0 min) -> snow-breathing phase (5min, 15min, and timepoint immediately before interruption [up to 60 min) (countinuous monitoring) |
| Cerebral Regional Oxygen Saturation (rSO2) | Changes in rSO2 (%) | Changes from baseline (measurement at 0 min) -> snow-breathing phase (5min, 15min, and timepoint immediately before interruption [up to 60 min) (countinuous monitoring) |
| NASA-task load index (NASA-TLX) questionnaire (perceived workload) | Changes in NASA-task load index (NASA-TLX) questionnaire (numerical scale) | Change from basal measurement (before hypoxia exposure) to post-exposure measurement (after hypoxia exposure - up to 60 min) |
| Reactive oxygen species - ROS | Changes in ROS in saliva samples (μmol/min) | Change from basal measurement (before hypoxia exposure) to post-exposure measurement (after hypoxia exposure - up to 60 min) |
| Total antioxidant capacity - TAC | Changes in TAC in saliva samples (mM) | Change from basal measurement (before hypoxia exposure) to post-exposure measurement (after hypoxia exposure - up to 60 min) |
| 29247235 | Background | Strapazzon G, Paal P, Schweizer J, Falk M, Reuter B, Schenk K, Gatterer H, Grasegger K, Dal Cappello T, Malacrida S, Riess L, Brugger H. Effects of snow properties on humans breathing into an artificial air pocket - an experimental field study. Sci Rep. 2017 Dec 15;7(1):17675. doi: 10.1038/s41598-017-17960-4. |
| 41060661 | Derived | Eisendle F, Roveri G, Rauch S, Thomassen O, Dal Cappello T, Assmus J, Malacrida S, Kammerer T, Schweizer J, Borasio N, Dorck V, Falk M, Falla M, Fruzzetti N, Maxenti M, Mydske S, Sasso GM, Vinetti G, Wallner B, Brattebo G, Brugger H, Strapazzon G. Respiratory Gas Shifts to Delay Asphyxiation in Critical Avalanche Burial: A Randomized Clinical Trial. JAMA. 2025 Oct 8;334(19):1720-7. doi: 10.1001/jama.2025.16837. Online ahead of print. |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |