An interventional study of Safeback SBX and Sham device in Avalanche, Landslide, or Mudslide and Asphyxia; Immersion, sponsored by Institute of Mountain Emergency Medicine. Status unknown at 1 site in Italy. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-22.
Sponsored by Institute of Mountain Emergency Medicine · Not applicable, Interventional, and Prevention
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.
39 studies on the registry are indexed under Asphyxia; 7 are open to participants now.
This study's planned enrollment of 26 is below the median of 111 across 24 interventional studies indexed under Asphyxia.
Browse Asphyxia studies →Institute of Mountain Emergency Medicine is the lead sponsor of 20 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Active Device
Device: Safeback SBX
Sham Device
Device: Sham device
The intervention consists in the test of the active device.
The intervention consists in a similar device to that emits same noise but does not deliver airflow.
Time limit
Reaching a predefined time limit (min)
Time frame: From baseline up to 60 minutes
Physiological threshold
Time to reach a SpO2 threshold up to \<75% (min)
Time frame: From baseline up to 60 minutes
End-tidal CO2 (EtCO2)
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)
Minute ventilation (VE)
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)
Cerebral Regional Oxygen Saturation (rSO2)
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)
NASA-task load index (NASA-TLX) questionnaire (perceived workload)
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)
Reactive oxygen species - ROS
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)
Total antioxidant capacity - TAC
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)
This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Institute of Mountain Emergency Medicine