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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Avalanche, Landslide, or Mudslide; Asphyxia; Immersion
• Intervention / Treatment: Device: Safeback SBX; Device: Sham device

• Study Type: Interventional
• Enrollment (Anticipated): 26
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Frederik Eisendle, Dr.; Phone Number: +39 0471 055 759; Email: frederik.eisendl@eurac.edu

Study Locations

• Italy
  • Bz
    • Bolzano, Bz, Italy, 39100
      • Recruiting
      • Institute of Mountain Emergency Medicine, Eurac Research
      • Contact: Giacomo Strapazzon, MD; Phone Number: 39 0471 055 543; Email: giacomo.strapazzon@eurac.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intervention; Active Device	Device: Safeback SBX; The intervention consists in the test of the active device.
Sham Comparator: Control; Sham Device	Device: Sham device; The intervention consists in a similar device to that emits same noise but does not deliver airflow.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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)

Collaborators and Investigators

• Sponsor: Institute of Mountain Emergency Medicine
• Collaborators: Haukeland University Hospital; Medical University Innsbruck
• Investigators: Principal Investigator: Giacomo Strapazzon, Dr., Institute of Mountain Emergency Medicine, Eurac Research

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2023
• Primary Completion (Anticipated): April 1, 2023
• Study Completion (Anticipated): February 1, 2024

Study Registration Dates

• First Submitted: February 13, 2023
• First Submitted That Met QC Criteria: March 9, 2023
• First Posted (Actual): March 22, 2023

Study Record Updates

• Last Update Posted (Actual): March 22, 2023
• Last Update Submitted That Met QC Criteria: March 9, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Cardiac arrest; Asphyxia; Avalanche; Avalanche burial; Emergengy medicine
• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Death; Asphyxia
• Other Study ID Numbers: SB1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No