NCT05073406: HEMS II

Cognition at Altitude in HEMS - Part II

Completed NA Last updated 1 March 2023

What this trial tests

NA trial testing Altitude exposure in hypobaric normoxic condition in Hypobaric Hypoxia in 36 participants. Completed in 31 December 2022.

Timeline

1 September 2021

Primary endpoint
31 December 2022

31 December 2022

Quick facts

Lead sponsor	Institute of Mountain Emergency Medicine
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	basic science
Enrollment	36
Start date	1 September 2021
Primary completion	31 December 2022
Estimated completion	31 December 2022
Sites	1 location across Italy

Drugs / interventions tested

• Altitude exposure in hypobaric normoxic condition
• Altitude exposure in hypobaric hypoxic condition

Conditions studied

• Hypobaric Hypoxia — all drugs for Hypobaric Hypoxia →
• Hypobaric Normoxia — all drugs for Hypobaric Normoxia →
• Cognitive Performance — all drugs for Cognitive Performance →
• Emergency Medicine — all drugs for Emergency Medicine →

Sponsor

Institute of Mountain Emergency Medicine

Who can join

Adults 18 to 60, any sex, with Hypobaric Hypoxia or Hypobaric Normoxia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Effect of oxygen supplementation on cognitive performance among HEMS providers after acute exposure to altitude: the HEMS II randomized clinical trial.
   Falla M, van Veelen MJ, Falk M, Weiss EM, et al · · 2024 · cited 6× · PMID 39075543 · DOI 10.1186/s13049-024-01238-6