Clinical trial NCT05779540: Efficacy and Pathophysiological Implications of a New Asphyxiation Delaying Device
Official title: A New Device to Delay Asphyxiation in Subjects Critically Buried in Avalanche Debris: Efficacy and Pathophysiological Implications
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Avalanche, Landslide, or Mudslide
Asphyxia; Immersion
Keywords: Avalanche
Avalanche burial
Cardiac arrest
Asphyxia
Emergengy medicine
Lead sponsor: Institute of Mountain Emergency Medicine
Sponsor class: OTHER
Collaborators: name: Medical University Innsbruck
name: Haukeland University Hospital
First posted: 2023-03-22
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Time limit
timeFrame: From baseline up to 60 minutes
measure: Physiological threshold
timeFrame: From baseline up to 60 minutes
Secondary outcomes:
measure: End-tidal CO2 (EtCO2)
timeFrame: Changes from baseline (measurement at 0 min) -> snow-breathing phase (5min, 15min, and timepoint immediately before interruption [up to 60 min) (countinuous monitoring)
measure: Minute ventilation (VE)
timeFrame: Changes from baseline (measurement at 0 min) -> snow-breathing phase (5min, 15min, and timepoint immediately before interruption [up to 60 min) (countinuous monitoring)
measure: Cerebral Regional Oxygen Saturation (rSO2)
timeFrame: Changes from baseline (measurement at 0 min) -> snow-breathing phase (5min, 15min, and timepoint immediately before interruption [up to 60 min) (countinuous monitoring)
measure: NASA-task load index (NASA-TLX) questionnaire (perceived workload)
timeFrame: Change from basal measurement (before hypoxia exposure) to post-exposure measurement (after hypoxia exposure - up to 60 min)
measure: Reactive oxygen species - ROS
timeFrame: Change from basal measurement (before hypoxia exposure) to post-exposure measurement (after hypoxia exposure - up to 60 min)
measure: Total antioxidant capacity - TAC
timeFrame: Change from basal measurement (before hypoxia exposure) to post-exposure measurement (after hypoxia exposure - up to 60 min)
Other outcomes:
Locations:
city: Bolzano
country: Italy
facility: Institute of Mountain Emergency Medicine, Eurac Research
state: Bz
Study officials:
affiliation: Institute of Mountain Emergency Medicine, Eurac Research
name: Giacomo Strapazzon, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.