Efficacy and Pathophysiological Implications of a New Asphyxiation Delaying Device

Avalanche, Landslide, or Mudslide Clinical Trial

— SAFEBACK  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05779540
• Other study ID #: SB1
• Status: Recruiting
• Phase: N/A
• Start date: February 15, 2023
• Est. completion date: February 2024

Study information

• Verified date: March 2023
• Source: Institute of Mountain Emergency Medicine
• Contact: Frederik Eisendle, Dr.
• Phone: +39 0471 055 759
• Email: frederik.eisendl[@]eurac.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 26
• Est. completion date: February 2024
• Est. primary completion date: April 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asphyxia
• Avalanche, Landslide, or Mudslide

Intervention

Device:
• Safeback SBX
The intervention consists in the test of the active device.
• Sham device
The intervention consists in a similar device to that emits same noise but does not deliver airflow.

Locations

Country	Name	City	State
Italy	Institute of Mountain Emergency Medicine, Eurac Research	Bolzano	Bz

Sponsors (3)

Lead Sponsor	Collaborator
Institute of Mountain Emergency Medicine	Haukeland University Hospital, Medical University Innsbruck

Country where clinical trial is conducted

Italy, 

References & Publications (3)

Falk M, Brugger H, Adler-Kastner L. Avalanche survival chances. Nature. 1994 Mar 3;368(6466):21. doi: 10.1038/368021a0. No abstract available. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time limit	Reaching a predefined time limit (min)	From baseline up to 60 minutes
Primary	Physiological threshold	Time to reach a SpO2 threshold up to <75% (min)	From baseline up to 60 minutes
Secondary	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)
Secondary	Minute ventilation (VE)	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)