Cognition at Altitude in HEMS - Part II

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.

Conditions

• Hypobaric Hypoxia
• Hypobaric Normoxia
• Cognitive Performance
• Emergency Medicine
• Stress Physiology

Interventions

OTHER

Altitude exposure in hypobaric normoxic condition

Altitude exposure with oxygen supplementation to achieve normoxia at altitude

OTHER

Altitude exposure in hypobaric hypoxic condition

Altitude exposure with air supplementation to obtain a sham comparator arm

Sponsors & Collaborators

• University Grenoble Alps

  collaborator OTHER

• Università degli Studi di Trento

  collaborator OTHER

• Medical University Innsbruck

  collaborator OTHER

• Institute of Mountain Emergency Medicine

  lead OTHER

Principal Investigators

• Giacomo Strapazzon, MD PhD · Eurac Research, Institute of Mountain Emergency Medicine

• Marika Falla, MD PhD · University of Trento, Center for Mind/Brain Sciences - CIMeC

• Michiel van Veelen, MD · Eurac Research, Institute of Mountain Emergency Medicine

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-09-01

Primary Completion

2022-12-31

Completion

2022-12-31

Countries

• Italy

Study Locations