NCT05779540

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 13, 2023

Completed
2 days until next milestone

Study Start

First participant enrolled

February 15, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 22, 2023

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

March 22, 2023

Status Verified

March 1, 2023

Enrollment Period

2 months

First QC Date

February 13, 2023

Last Update Submit

March 9, 2023

Conditions

Avalanche, Landslide, or MudslideAsphyxia; Immersion

Keywords

AvalancheAvalanche burialCardiac arrestAsphyxiaEmergengy medicine

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (6)

  • End-tidal CO2 (EtCO2)

    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 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 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)

    Change from basal measurement (before hypoxia exposure) to post-exposure measurement (after hypoxia exposure - up to 60 min)

  • Reactive oxygen species - ROS

    Change from basal measurement (before hypoxia exposure) to post-exposure measurement (after hypoxia exposure - up to 60 min)

  • +1 more secondary outcomes

Study Arms (2)

Intervention

ACTIVE COMPARATOR

Active Device

Device: Safeback SBX

Control

SHAM COMPARATOR

Sham Device

Device: Sham device

Interventions

Safeback SBXDEVICE

The intervention consists in the test of the active device.

Intervention
Sham deviceDEVICE

The intervention consists in a similar device to that emits same noise but does not deliver airflow.

Control

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \- healthy ASA I subjects

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Mountain Emergency Medicine, Eurac Research

Bolzano, Bz, 39100, Italy

RECRUITING

Related Publications (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.

    PMID: 7969398BACKGROUND

  • 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.

    PMID: 35063621BACKGROUND

  • 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.

    PMID: 29247235BACKGROUND

  • 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.

    PMID: 41060661DERIVED

MeSH Terms

Conditions

AsphyxiaHeart Arrest

Condition Hierarchy (Ancestors)

DeathPathologic ProcessesPathological Conditions, Signs and SymptomsWounds and InjuriesHeart DiseasesCardiovascular Diseases

Study Officials

  • Giacomo Strapazzon, Dr.

    Institute of Mountain Emergency Medicine, Eurac Research

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Frederik Eisendle, Dr.

CONTACT

+39 0471 055 759frederik.eisendl@eurac.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

February 13, 2023

First Posted

March 22, 2023

Study Start

February 15, 2023

Primary Completion

April 1, 2023

Study Completion

February 1, 2024

Last Updated

March 22, 2023

Record last verified: 2023-03

Locations

IT(1)