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| Name | Class |
|---|---|
| Medical University Innsbruck | OTHER |
| University of Graz | OTHER |
| Università degli Studi di Trento | OTHER |
| Azienda Sanitaria dell'Alto Adige |
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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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 200-3000 | Experimental | Day 1: 200m (above sea level) asl Day 2: 3000m asl |
|
| 3000-200 | Experimental | Day 1: 3000m asl Day 2: 200m asl |
|
| 200-5000 | Experimental | Day 1: 200m asl Day 2: 5000m asl |
|
| 5000-200 | Experimental | Day 1: 5000m asl Day 2: 200m asl |
|
| 3000-5000 | Experimental | Day 1: 3000m asl Day 2: 5000m asl |
|
| 5000-3000 | Active Comparator | Day 1: 5000m asl Day 2: 3000m asl |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Altitude exposure in climate chamber | Other | Altitude exposure in a climate chamber will consist of hypobaric hypoxia similar to the conditions found at 3000m asl and 5000m asl. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| 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) |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Balloon Analog Risk Test - BART |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Giacomo Strapazzon, MD PhD | Eurac Research, Institute of Mountain Emergency Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eurac Research, Institute of Mountain Emergency Medicine | Bolzano | BZ | 39100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26779029 | Background | 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. | |
| 30760298 | Background | 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. |
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All of the individual participant data collected during the trial, after deidentification
Data will be available within 6 months from study completion
Access will be granted to primary collaborators who will be required to sign a Data Access agreement
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| OTHER |
| Istituto di Fisiologia Clinica CNR | OTHER |
Interventional, non-pharmacological, randomized, controlled, single-blinded, cross-over
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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) |
| 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) |
| 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 |
| 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) |
| 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) |
| 11892743 | Background | 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. |
| 29789086 | Background | 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. |
| 26564759 | Background | 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. |
| 25154345 | Background | 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. |
| 34854317 | Derived | 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. |