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

March 9, 2023 updated by: Giacomo Strapazzon, MD PhD, Institute of Mountain Emergency Medicine

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

Study Type

Interventional

Enrollment (Anticipated)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Bz
      • Bolzano, Bz, Italy, 39100
        • Recruiting
        • Institute of Mountain Emergency Medicine, Eurac Research
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intervention
Active Device
The intervention consists in the test of the active device.
Sham Comparator: Control
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
Time Frame: From baseline up to 60 minutes
Reaching a predefined time limit (min)
From baseline up to 60 minutes
Physiological threshold
Time Frame: From baseline up to 60 minutes
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)
Time Frame: Changes from baseline (measurement at 0 min) -> snow-breathing phase (5min, 15min, and timepoint immediately before interruption [up to 60 min) (countinuous monitoring)
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)
Time Frame: Changes from baseline (measurement at 0 min) -> snow-breathing phase (5min, 15min, and timepoint immediately before interruption [up to 60 min) (countinuous monitoring)
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)
Time Frame: Changes from baseline (measurement at 0 min) -> snow-breathing phase (5min, 15min, and timepoint immediately before interruption [up to 60 min) (countinuous monitoring)
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)
Time Frame: Change from basal measurement (before hypoxia exposure) to post-exposure measurement (after hypoxia exposure - up to 60 min)
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
Time Frame: Change from basal measurement (before hypoxia exposure) to post-exposure measurement (after hypoxia exposure - up to 60 min)
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
Time Frame: Change from basal measurement (before hypoxia exposure) to post-exposure measurement (after hypoxia exposure - up to 60 min)
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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Giacomo Strapazzon, Dr., Institute of Mountain Emergency Medicine, Eurac Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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