A New Device to Delay Asphyxiation in Subjects Critically Buried in Avalanche Debris: Efficacy and Pathophysiological Implications
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 26
- Locations
- 2
- Primary Endpoint
- Time limit
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
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)
Secondary Outcomes
- 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))
- 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))
- 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))
- 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))
- Reactive oxygen species - ROS(Change from basal measurement (before hypoxia exposure) to post-exposure measurement (after hypoxia exposure - up to 60 min))
- Total antioxidant capacity - TAC(Change from basal measurement (before hypoxia exposure) to post-exposure measurement (after hypoxia exposure - up to 60 min))
Investigators
Giacomo Strapazzon, MD PhD
Dr.
Institute of Mountain Emergency Medicine