Effects of Acute Hypobaric Hypoxia Exposure on Neurocognitive Performance of Pre-hospital Emergency Service Providers
NCT ID: NCT04138446
Last Updated: 2020-03-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
48 participants
INTERVENTIONAL
2019-10-25
2019-11-11
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
DOUBLE
Study Groups
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200-3000
Day 1: 200m (above sea level) asl Day 2: 3000m asl
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.
3000-200
Day 1: 3000m asl Day 2: 200m asl
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.
200-5000
Day 1: 200m asl Day 2: 5000m asl
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.
5000-200
Day 1: 5000m asl Day 2: 200m asl
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.
3000-5000
Day 1: 3000m asl Day 2: 5000m asl
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.
5000-3000
Day 1: 5000m asl Day 2: 3000m asl
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Age 18-60 yr-old
* ASA class I
* Signed informed consent
Exclusion Criteria
* ASA class \> I
* Informed consent not signed
18 Years
60 Years
ALL
Yes
Sponsors
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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
Institute of Mountain Emergency Medicine
OTHER
Responsible Party
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Giacomo Strapazzon, MD PhD
Principal Investigator
Principal Investigators
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Giacomo Strapazzon, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Eurac Research, Institute of Mountain Emergency Medicine
Locations
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Eurac Research, Institute of Mountain Emergency Medicine
Bolzano, BZ, Italy
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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3489044136
Identifier Type: -
Identifier Source: org_study_id
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