Efficacy and Pathophysiological Implications of a New Asphyxiation Delaying Device (SAFEBACK)
Primary Purpose
Avalanche, Landslide, or Mudslide, Asphyxia; Immersion
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Safeback SBX
Sham device
Sponsored by
About this trial
This is an interventional prevention trial for Avalanche, Landslide, or Mudslide focused on measuring Avalanche, Avalanche burial, Cardiac arrest, Asphyxia, Emergengy medicine
Eligibility Criteria
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.
Sites / Locations
- Institute of Mountain Emergency Medicine, Eurac ResearchRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Intervention
Control
Arm Description
Active Device
Sham Device
Outcomes
Primary Outcome Measures
Time limit
Reaching a predefined time limit (min)
Physiological threshold
Time to reach a SpO2 threshold up to <75% (min)
Secondary Outcome Measures
End-tidal CO2 (EtCO2)
Changes in EtCO2 (mmHg)
Minute ventilation (VE)
Changes in VE (L/min)
Cerebral Regional Oxygen Saturation (rSO2)
Changes in rSO2 (%)
NASA-task load index (NASA-TLX) questionnaire (perceived workload)
Changes in NASA-task load index (NASA-TLX) questionnaire (numerical scale)
Reactive oxygen species - ROS
Changes in ROS in saliva samples (μmol/min)
Total antioxidant capacity - TAC
Changes in TAC in saliva samples (mM)
Full Information
NCT ID
NCT05779540
First Posted
February 13, 2023
Last Updated
March 9, 2023
Sponsor
Institute of Mountain Emergency Medicine
Collaborators
Medical University Innsbruck, Haukeland University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05779540
Brief Title
Efficacy and Pathophysiological Implications of a New Asphyxiation Delaying Device
Acronym
SAFEBACK
Official Title
A New Device to Delay Asphyxiation in Subjects Critically Buried in Avalanche Debris: Efficacy and Pathophysiological Implications
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 15, 2023 (Actual)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
February 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institute of Mountain Emergency Medicine
Collaborators
Medical University Innsbruck, Haukeland University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Avalanche, Landslide, or Mudslide, Asphyxia; Immersion
Keywords
Avalanche, Avalanche burial, Cardiac arrest, Asphyxia, Emergengy medicine
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
26 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Active Comparator
Arm Description
Active Device
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
Sham Device
Intervention Type
Device
Intervention Name(s)
Safeback SBX
Intervention Description
The intervention consists in the test of the active device.
Intervention Type
Device
Intervention Name(s)
Sham device
Intervention Description
The intervention consists in a similar device to that emits same noise but does not deliver airflow.
Primary Outcome Measure Information:
Title
Time limit
Description
Reaching a predefined time limit (min)
Time Frame
From baseline up to 60 minutes
Title
Physiological threshold
Description
Time to reach a SpO2 threshold up to <75% (min)
Time Frame
From baseline up to 60 minutes
Secondary Outcome Measure Information:
Title
End-tidal CO2 (EtCO2)
Description
Changes in EtCO2 (mmHg)
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)
Title
Minute ventilation (VE)
Description
Changes in VE (L/min)
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)
Title
Cerebral Regional Oxygen Saturation (rSO2)
Description
Changes in 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)
Title
NASA-task load index (NASA-TLX) questionnaire (perceived workload)
Description
Changes in NASA-task load index (NASA-TLX) questionnaire (numerical scale)
Time Frame
Change from basal measurement (before hypoxia exposure) to post-exposure measurement (after hypoxia exposure - up to 60 min)
Title
Reactive oxygen species - ROS
Description
Changes in ROS in saliva samples (μmol/min)
Time Frame
Change from basal measurement (before hypoxia exposure) to post-exposure measurement (after hypoxia exposure - up to 60 min)
Title
Total antioxidant capacity - TAC
Description
Changes in TAC in saliva samples (mM)
Time Frame
Change from basal measurement (before hypoxia exposure) to post-exposure measurement (after hypoxia exposure - up to 60 min)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Frederik Eisendle, Dr.
Phone
+39 0471 055 759
Email
frederik.eisendl@eurac.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giacomo Strapazzon, Dr.
Organizational Affiliation
Institute of Mountain Emergency Medicine, Eurac Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Mountain Emergency Medicine, Eurac Research
City
Bolzano
State/Province
Bz
ZIP/Postal Code
39100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giacomo Strapazzon, MD
Phone
39 0471 055 543
Email
giacomo.strapazzon@eurac.edu
12. IPD Sharing Statement
Citations:
PubMed Identifier
7969398
Citation
Falk M, Brugger H, Adler-Kastner L. Avalanche survival chances. Nature. 1994 Mar 3;368(6466):21. doi: 10.1038/368021a0. No abstract available.
Results Reference
background
PubMed Identifier
35063621
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.
Results Reference
background
PubMed Identifier
29247235
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.
Results Reference
background
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Efficacy and Pathophysiological Implications of a New Asphyxiation Delaying Device
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