Cognition at Altitude in HEMS - Part II
Condition: Hypobaric Hypoxia; Hypobaric Normoxia; Cognitive Performance; Emergency Medicine; Stress Physiology
MeSH terms: Emergencies; Hypoxia
Study type: Interventional

Summary: 
      The aim of the current study is to evaluate under blinded conditions, both in a simulated
      environment and during helicopter flight, the effect of a rapid (within 20 minutes) exposure
      to altitude (4000 m asl) on physiological parameters and selected cognitive domains, in
      providers operating in helicopter emergency medical service (HEMS) exposed to hypobaric
      hypoxia or to hypobaric normoxia (H0: cognitive effects under hypobaric hypoxia = cognitive
      effects under hypobaric normoxia). Simulated environment will allow to control different
      factors. The parallelism between a study branch conducted in a simulated environment and
      another one conducted under a real-life condition will allow to evaluate the additive effects
      on additional stressor factors (processive and systemic ones).

        -  Simulation branch: each participant will take part in three research sessions: a
           familiarization session and two experimental sessions in simulation facility called
           terraXcube (test 1 and 2). On test 1 and test 2 each group will be exposed twice to the
           simulated altitude of 4000 m asl (under hypobaric hypoxia or hypobaric normoxia
           conditions) according to the randomization protocol. Participants will perform the
           neurocognitive tests three times on each of the two tests: before the ascent (TC0),
           after 5 min from the end of the ascent (TC1) and after around 30 min (TC2), to
           investigate European Union Aviation Safe Agency (EASA) proposed recommendations. After
           completing each neurocognitive test session, participants will be asked to rate their
           performance using a visual analogue scales (VAS). All participants will wear the vital
           parameters monitoring system during the entire duration of the tests inside the chamber,
           as well as the cerebral oxygen saturation (ScO2) sensor. Samples will be collected by
           saliva, urine and/or capillary blood. The same schedule is repeated in each test
           session.

        -  In-field branch: each participant will take part in three research sessions: a
           familiarization session and two experimental sessions during helicopter flights (test 1
           and 2). On test 1 and test 2 each group will be exposed twice to the altitude of 4000 m
           (under hypobaric hypoxia or hypobaric normoxia conditions) according to the
           randomization protocol. Participants will perform the neurocognitive test two times on
           each test: before the ascent (TC0), after around 5 min from the end of the ascent (TC1).
           After completing each neurocognitive tests, participants will be asked to rate their
           performance using a visual analogue scales (VAS). All participants will wear the vital
           parameters monitoring system during the entire duration of the tests. Samples will be
           collected. The same schedule is planned in each test session.
    


Intervention name(s): Altitude exposure in hypobaric normoxic condition; Altitude exposure in hypobaric hypoxic condition
Intervention type(s): Other; Other
Intervention description(s): Altitude exposure with oxygen supplementation to achieve normoxia at altitude; Altitude exposure with air supplementation to obtain a sham comparator arm
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Interventional, non-pharmacological, randomized, controlled, double-blinded, cross-over
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science