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

• Sponsor: Institute of Mountain Emergency Medicine (Other)
• Overall Status: Completed
• CT.gov ID: NCT04138446
• Collaborator: Medical University Innsbruck (Other), University of Graz (Other), Università degli Studi di Trento (Other), Azienda Sanitaria dell'Alto Adige (Other), Istituto di Fisiologia Clinica CNR (Other)
• Enrollment: 48
• Location: 1
• Arms: 6
• Actual Duration (Days): 17
• Patients Per Site Per Month: 85.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypobaric Hypoxia; Cognitive Deterioration; Emergency Medicine; Resuscitation; Stress Physiology	Other: Altitude exposure in climate chamber	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 48 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Interventional, non-pharmacological, randomized, controlled, single-blinded, cross-overInterventional, non-pharmacological, randomized, controlled, single-blinded, cross-over
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: Effects of Acute Hypobaric Hypoxia Exposure on Neurocognitive Performance of Pre-hospital Emergency Service Providers
• Actual Study Start Date: Oct 25, 2019
• Actual Primary Completion Date: Nov 11, 2019
• Actual Study Completion Date: Nov 11, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 200-3000 Day 1: 200m (above sea level) asl Day 2: 3000m asl	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.
Experimental: 3000-200 Day 1: 3000m asl Day 2: 200m asl	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.
Experimental: 200-5000 Day 1: 200m asl Day 2: 5000m asl	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.
Experimental: 5000-200 Day 1: 5000m asl Day 2: 200m asl	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.
Experimental: 3000-5000 Day 1: 3000m asl Day 2: 5000m asl	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.
Active Comparator: 5000-3000 Day 1: 5000m asl Day 2: 3000m asl	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.

Outcome Measures

Primary Outcome Measures

1. Digit-Symbol Substitution Task - DSST [Change from basal measurement (before altitude exposure) to altitude measurement (after altitude exposure - 5 minutes)]

   Changes in working memory at altitude using a computer-based test (DSST)

2. Balloon Analog Risk Test - BART [Change from basal measurement (before altitude exposure) to altitude measurement (after altitude exposure - 5 minutes)]

   Changes in risk-taking behavior at altitude using a computer-based test (BART)

3. Psychomotor Vigilance Test - PVT [Change from basal measurement (before altitude exposure) to altitude measurement (after altitude exposure - 5 minutes)]

   Changes in reaction time using a computer-based test (PVT)

Secondary Outcome Measures

1. Digit-Symbol Substitution Task - DSST [Change from rest measurement (altitude exposure before chest compressions) to post-exercise measurement (after 5 minutes of chest compressions at altitude)]

   Changes in working memory after exercise at altitude using a computer-based test (DSST)

2. Balloon Analog Risk Test - BART [Change from rest measurement (altitude exposure before chest compressions) to post-exercise measurement (after 5 minutes of chest compressions at altitude)]

   Changes in risk-taking behavior after exercise at altitude using a computer-based test (BART)

3. Psychomotor Vigilance Test - PVT [Change from rest measurement (altitude exposure before chest compressions) to post-exercise measurement (after 5 minutes of chest compressions at altitude)]

   Changes in reaction time after exercise at altitude using a computer-based test battery (PVT)

4. Proportion of correct chest compressions regarding depth, pressure point and pressure release [Changes in 5 minute chest compressions]

   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)

5. Reactive oxygen species - ROS [Change from basal measurement (before altitude exposure) to post-altitude measurement (after altitude exposure - 1 hour)]

   Changes in ROS in saliva samples (μmol/min)

6. Total antioxidant capacity - TAC [Change from basal measurement (before altitude exposure) to post-altitude measurement (after altitude exposure - 1 hour)]

   Changes in TAC in saliva samples (mM)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Eurac Research, Institute of Mountain Emergency Medicine	Bolzano	BZ	Italy	39100

Sponsors and Collaborators

• Institute of Mountain Emergency Medicine
• Medical University Innsbruck
• University of Graz
• Università degli Studi di Trento
• Azienda Sanitaria dell'Alto Adige
• Istituto di Fisiologia Clinica CNR

Investigators

• Principal Investigator: Giacomo Strapazzon, MD PhD, Eurac Research, Institute of Mountain Emergency Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

• Responsible Party: Giacomo Strapazzon, MD PhD, Principal Investigator, Institute of Mountain Emergency Medicine
• ClinicalTrials.gov Identifier: NCT04138446
• Other Study ID Numbers: 3489044136
• First Posted: Oct 24, 2019
• Last Update Posted: Mar 24, 2020
• Last Verified: Mar 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Emergencies; Hypoxia

Study Results

No Results Posted as of Mar 24, 2020