Efficacy and Pathophysiological Implications of a New Asphyxiation Delaying Device
- Conditions
- Avalanche, Landslide, or MudslideAsphyxia; Immersion
- Interventions
- Device: Sham deviceDevice: Safeback SBX
- Registration Number
- NCT05779540
- Lead Sponsor
- Institute of Mountain Emergency Medicine
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 26
- healthy ASA I subjects
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Sham device Sham Device Intervention Safeback SBX Active Device
- Primary Outcome Measures
Name Time Method Time limit From baseline up to 60 minutes Reaching a predefined time limit (min)
Physiological threshold From baseline up to 60 minutes Time to reach a SpO2 threshold up to \<75% (min)
- Secondary Outcome Measures
Name Time Method 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) Changes in EtCO2 (mmHg)
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) Changes in VE (L/min)
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) Changes in rSO2 (%)
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) Changes in NASA-task load index (NASA-TLX) questionnaire (numerical scale)
Reactive oxygen species - ROS 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)
Total antioxidant capacity - TAC 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)
Trial Locations
- Locations (1)
Institute of Mountain Emergency Medicine, Eurac Research
🇮🇹Bolzano, Bz, Italy