Clinical trial NCT04138446: Effects of Acute Hypobaric Hypoxia Exposure on Neurocognitive Performance of Pre-hospital Emergency Service Providers
Official title: Effects of Acute Hypobaric Hypoxia Exposure on Neurocognitive Performance of Pre-hospital Emergency Service Providers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypobaric Hypoxia
Cognitive Deterioration
Emergency Medicine
Resuscitation
Stress Physiology
Lead sponsor: Institute of Mountain Emergency Medicine
Sponsor class: OTHER
Collaborators: name: Medical University Innsbruck
name: University of Graz
name: Università degli Studi di Trento
name: Azienda Sanitaria dell'Alto Adige
name: Istituto di Fisiologia Clinica CNR
First posted: 2019-10-24
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Interventional, non-pharmacological, randomized, controlled, single-blinded, cross-over
Primary purpose: BASIC_SCIENCE

Brief summary: The study aims to evaluate the effects of acute hypobaric hypoxia on cognitive performance (H0: cognitive performance at 200 meters above sea level (asl) = cognitive performance at 3000 meters above sea level = cognitive performance at 5000 meters above sea level).

Before participating in the study, each participant will respond to a questionnaire related to high altitude exposure (prior 3 months), as well as inclusion/exclusion criteria evaluation.

On day 0, after the interview and signed informed consent, the participant will undergo a medical examination that will include a general objective examination. Participants will participate in a training on the emergency and safety procedures of the hypobaric hypoxia facility, as well as a refresh on cardiopulmonary resuscitation procedure.

During the following two days (day 1 and 2) the study protocol will be executed (one test per day). The study protocol envisages:

* a basal cognitive test battery
* blind ascent in the hypobaric chamber to simulated altitude
* cognitive test battery
* 5 minutes of recorded chest compressions on dummies
* cognitive test battery
* blind descent in the hypobaric chamber.

During the stay in the hypobaric hypoxic facility, each participant will be monitored in real time with the Equivital© medical monitoring device.

Before and after the stay in the hypobaric hypoxic facility, a saliva sample will be collected, and psychological tests administered.


Eligibility criteria: Inclusion criteria:

* Healthy volunteers
* Age 18-60 yr-old
* ASA class I
* Signed informed consent

Exclusion criteria:

* Age \<18 or \>60 yr-old
* ASA class \> I
* Informed consent not signed

Primary outcomes:
measure: Digit-Symbol Substitution Task - DSST
timeFrame: Change from basal measurement (before altitude exposure) to altitude measurement (after altitude exposure - 5 minutes)
measure: Balloon Analog Risk Test - BART
timeFrame: Change from basal measurement (before altitude exposure) to altitude measurement (after altitude exposure - 5 minutes)
measure: Psychomotor Vigilance Test - PVT
timeFrame: Change from basal measurement (before altitude exposure) to altitude measurement (after altitude exposure - 5 minutes)
Secondary outcomes:
measure: Digit-Symbol Substitution Task - DSST
timeFrame: Change from rest measurement (altitude exposure before chest compressions) to post-exercise measurement (after 5 minutes of chest compressions at altitude)
measure: Balloon Analog Risk Test - BART
timeFrame: Change from rest measurement (altitude exposure before chest compressions) to post-exercise measurement (after 5 minutes of chest compressions at altitude)
measure: Psychomotor Vigilance Test - PVT
timeFrame: Change from rest measurement (altitude exposure before chest compressions) to post-exercise measurement (after 5 minutes of chest compressions at altitude)
measure: Proportion of correct chest compressions regarding depth, pressure point and pressure release
timeFrame: Changes in 5 minute chest compressions
measure: Reactive oxygen species - ROS
timeFrame: Change from basal measurement (before altitude exposure) to post-altitude measurement (after altitude exposure - 1 hour)
measure: Total antioxidant capacity - TAC
timeFrame: Change from basal measurement (before altitude exposure) to post-altitude measurement (after altitude exposure - 1 hour)
Other outcomes:
Locations:
city: Bolzano
country: Italy
facility: Eurac Research, Institute of Mountain Emergency Medicine
state: BZ
Study officials:
affiliation: Eurac Research, Institute of Mountain Emergency Medicine
name: Giacomo Strapazzon, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Taylor L, Watkins SL, Marshall H, Dascombe BJ, Foster J. The Impact of Different Environmental Conditions on Cognitive Function: A Focused Review. Front Physiol. 2016 Jan 6;6:372. doi: 10.3389/fphys.2015.00372. eCollection 2015.
citation: Pietsch U, Strapazzon G, Ambuhl D, Lischke V, Rauch S, Knapp J. Challenges of helicopter mountain rescue missions by human external cargo: need for physicians onsite and comprehensive training. Scand J Trauma Resusc Emerg Med. 2019 Feb 13;27(1):17. doi: 10.1186/s13049-019-0598-2.
citation: Li XY, Wu XY, Fu C, Shen XF, Yang CB, Wu YH. Effects of acute exposure to mild or moderate hypoxia on human psychomotor performance and visual-reaction time. Space Med Med Eng (Beijing). 2000 Aug;13(4):235-9.
citation: Bouak F, Vartanian O, Hofer K, Cheung B. Acute Mild Hypoxic Hypoxia Effects on Cognitive and Simulated Aircraft Pilot Performance. Aerosp Med Hum Perform. 2018 Jun 1;89(6):526-535. doi: 10.3357/AMHP.5022.2018.
citation: Basner M, Savitt A, Moore TM, Port AM, McGuire S, Ecker AJ, Nasrini J, Mollicone DJ, Mott CM, McCann T, Dinges DF, Gur RC. Development and Validation of the Cognition Test Battery for Spaceflight. Aerosp Med Hum Perform. 2015 Nov;86(11):942-52. doi: 10.3357/AMHP.4343.2015.
citation: Wang JC, Tsai SH, Chen YL, Hsu CW, Lai KC, Liao WI, Li LY, Kao WF, Fan JS, Chen YH. The physiological effects and quality of chest compressions during CPR at sea level and high altitude. Am J Emerg Med. 2014 Oct;32(10):1183-8. doi: 10.1016/j.ajem.2014.07.007. Epub 2014 Jul 30.
citation: Vogele A, van Veelen MJ, Dal Cappello T, Falla M, Nicoletto G, Dejaco A, Palma M, Hufner K, Brugger H, Strapazzon G. Effect of Acute Exposure to Altitude on the Quality of Chest Compression-Only Cardiopulmonary Resuscitation in Helicopter Emergency Medical Services Personnel: A Randomized, Controlled, Single-Blind Crossover Trial. J Am Heart Assoc. 2021 Dec 7;10(23):e021090. doi: 10.1161/JAHA.121.021090. Epub 2021 Dec 2.