Effects of Acute Hypobaric Hypoxia Exposure on Neurocognitive Performance of Pre-hospital Emergency Service Providers

Resuscitation Clinical Trial

Official title:

Effects of Acute Hypobaric Hypoxia Exposure on Neurocognitive Performance of Pre-hospital Emergency Service Providers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04138446
• Other study ID #: 3489044136
• Status: Completed
• Phase: N/A
• Start date: October 25, 2019
• Est. completion date: November 11, 2019

Study information

• Verified date: March 2020
• Source: Institute of Mountain Emergency Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: November 11, 2019
• Est. primary completion date: November 11, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Deterioration
• Emergencies
• Emergency Medicine
• Hypobaric Hypoxia
• Hypoxia
• Resuscitation
• Stress Physiology

Intervention

Other:
• Altitude exposure in climate chamber
Altitude exposure in a climate chamber will consist of hypobaric hypoxia similar to the conditions found at 3000m asl and 5000m asl.

Locations

Country	Name	City	State
Italy	Eurac Research, Institute of Mountain Emergency Medicine	Bolzano	BZ

Sponsors (6)

Lead Sponsor	Collaborator
Institute of Mountain Emergency Medicine	Azienda Sanitaria dell'Alto Adige, Istituto di Fisiologia Clinica CNR, Medical University Innsbruck, University of Graz, University of Trento

Country where clinical trial is conducted

Italy, 

References & Publications (6)

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. — View 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. — View 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. — View Citation

Pietsch U, Strapazzon G, Ambühl 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. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Digit-Symbol Substitution Task - DSST	Changes in working memory at altitude using a computer-based test (DSST)	Change from basal measurement (before altitude exposure) to altitude measurement (after altitude exposure - 5 minutes)
Primary	Balloon Analog Risk Test - BART	Changes in risk-taking behavior at altitude using a computer-based test (BART)	Change from basal measurement (before altitude exposure) to altitude measurement (after altitude exposure - 5 minutes)
Primary	Psychomotor Vigilance Test - PVT	Changes in reaction time using a computer-based test (PVT)	Change from basal measurement (before altitude exposure) to altitude measurement (after altitude exposure - 5 minutes)
Secondary	Digit-Symbol Substitution Task - DSST	Changes in working memory after exercise at altitude using a computer-based test (DSST)	Change from rest measurement (altitude exposure before chest compressions) to post-exercise measurement (after 5 minutes of chest compressions at altitude)
Secondary	Balloon Analog Risk Test - BART	Changes in risk-taking behavior after exercise at altitude using a computer-based test (BART)	Change from rest measurement (altitude exposure before chest compressions) to post-exercise measurement (after 5 minutes of chest compressions at altitude)
Secondary	Psychomotor Vigilance Test - PVT	Changes in reaction time after exercise at altitude using a computer-based test battery (PVT)	Change from rest measurement (altitude exposure before chest compressions) to post-exercise measurement (after 5 minutes of chest compressions at altitude)
Secondary	Proportion of correct chest compressions regarding depth, pressure point and pressure release	Evaluation of the quality of chest compressions with a manikin and its electronic feedback device at different altitudes (200 meters vs. 3000 meters vs. 5000 meters)	Changes in 5 minute chest compressions
Secondary	Reactive oxygen species - ROS	Changes in ROS in saliva samples (µmol/min)	Change from basal measurement (before altitude exposure) to post-altitude measurement (after altitude exposure - 1 hour)
Secondary	Total antioxidant capacity - TAC	Changes in TAC in saliva samples (mM)	Change from basal measurement (before altitude exposure) to post-altitude measurement (after altitude exposure - 1 hour)