Avalanche, Landslide, or MudslideSAFEBACKNCT05779540
Efficacy and Pathophysiological Implications of a New Asphyxiation Delaying Device
A study testing Safeback SBX in people with Avalanche, Landslide, or Mudslide and Asphyxia; Immersion, run by Institute of Mountain Emergency Medicine at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Avalanche, Landslide, or Mudslide, Asphyxia; Immersion
- What is being tested?
- Safeback SBX
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteItaly
- Study dates
- 15 Feb 2023to Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy ASA I subjects
Who cannot join
- ASA class II or higher
- chronic high degree cardiovascular or pulmonary disease
- claustrophobia
- psychiatric or neurological disease
- long-term medication
- pregnant woman
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Institute of Mountain Emergency Medicine, Eurac Research
Bolzano, Bz, 39100
Giacomo Strapazzon, MD, 39 0471 055 543, giacomo.strapazzon@eurac.edu
About this study
Official title: 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.
- Being tested
- Safeback SBX, Sham device
- Keywords
- Avalanche, Avalanche burial, Cardiac arrest, Asphyxia, Emergengy medicine
- Medical subject headings
- Asphyxia, Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Safeback SBXDevice
The intervention consists in the test of the active device.
Sham deviceDevice
The intervention consists in a similar device to that emits same noise but does not deliver airflow.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | Active Device Receives: Device: Safeback SBX |
| Control | Sham comparator | Sham Device Receives: Device: Sham device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time limit
Reaching a predefined time limit (min)
Measured: From baseline up to 60 minutes
Physiological threshold
Time to reach a SpO2 threshold up to <75% (min)
Measured: From baseline up to 60 minutes
Secondary outcomes (6)
End-tidal CO2 (EtCO2)
Changes in EtCO2 (mmHg)
Measured: 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)
Measured: 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 (%)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Change from basal measurement (before hypoxia exposure) to post-exposure measurement (after hypoxia exposure - up to 60 min)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2023
- Study start15 Feb 2023
- Primary completionApr 2023 (estimated)
- Study completionFeb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Avalanche, Landslide, or MudslideStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Mountain Emergency Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University Innsbruck, Haukeland University Hospital
- Responsible party
- Principal investigator, Giacomo Strapazzon, MD PhD, Institute of Mountain Emergency Medicine
- Investigators
- Giacomo Strapazzon, Dr., Principal investigator, Institute of Mountain Emergency Medicine, Eurac Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05779540
- Sponsor's protocol ID
- SB1
- Acronym
- SAFEBACK
- Status last verified
- Mar 2023
- First submitted
- 13 Feb 2023
- Last updated
- 22 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Falk M, Brugger H, Adler-Kastner L. Avalanche survival chances. Nature. 1994 Mar 3;368(6466):21. doi: 10.1038/368021a0. No abstract available.
PubMed 7969398Wik 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.
PubMed 35063621Strapazzon 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.
PubMed 29247235Eisendle 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.
PubMed 41060661
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Device to Delay Asphyxiation in Subjects Critically Buried in Avalanche Debris: Efficacy and Pathophysiological Implications
- ClinicalTrials.gov ID
- NCT05779540
- Acronym / sponsor ID
- SAFEBACK / SB1
- Keywords
- Avalanche, Avalanche burial, Cardiac arrest, Asphyxia, Emergengy medicine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Institute of Mountain Emergency MedicineUniversity, hospital or other
- Collaborators
- Medical University Innsbruck, Haukeland University Hospital
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 22 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Device: Safeback SBXActive Device |
| Control | Sham comparator | Device: Sham deviceSham Device |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy ASA I subjects
Key exclusion criteria (10 listed)
- ASA class II or higher
- chronic high degree cardiovascular or pulmonary disease
- claustrophobia
- psychiatric or neurological disease
- long-term medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Safeback SBXThe intervention consists in the test of the active device. | Device | Intervention |
| Sham deviceThe intervention consists in a similar device to that emits same noise but does not deliver airflow. | Device | Control |
Primary outcome
Time limit
Time frame: From baseline up to 60 minutes
Reaching a predefined time limit (min)
Physiological threshold
Time frame: From baseline up to 60 minutes
Time to reach a SpO2 threshold up to <75% (min)
6 secondary outcomes
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)
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)
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)
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)
Reactive oxygen species - ROS
Time frame: 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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2023.
- Background: PubMed 7969398Falk M, Brugger H, Adler-Kastner L. Avalanche survival chances. Nature. 1994 Mar 3;368(6466):21. doi: 10.1038/368021a0. No abstract available.
- Background: PubMed 35063621Wik 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.
- Background: PubMed 29247235Strapazzon 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.
- Derived from this study: PubMed 41060661Eisendle 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giacomo Strapazzon, Dr. principal investigator
Institute of Mountain Emergency Medicine, Eurac Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Safeback SBX in people with Avalanche, Landslide, or Mudslide and Asphyxia; Immersion, run by Institute of Mountain Emergency Medicine at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Frederik Eisendle, Dr. (+39 0471 055 759, frederik.eisendl@eurac.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time limit (time frame: From baseline up to 60 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05779540, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2023.