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
36 participants
INTERVENTIONAL
2021-09-01
2022-12-31
Brief Summary
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* Simulation branch: each participant will take part in three research sessions: a familiarization session and two experimental sessions in simulation facility called terraXcube (test 1 and 2). On test 1 and test 2 each group will be exposed twice to the simulated altitude of 4000 m asl (under hypobaric hypoxia or hypobaric normoxia conditions) according to the randomization protocol. Participants will perform the neurocognitive tests three times on each of the two tests: before the ascent (TC0), after 5 min from the end of the ascent (TC1) and after around 30 min (TC2), to investigate European Union Aviation Safe Agency (EASA) proposed recommendations. After completing each neurocognitive test session, participants will be asked to rate their performance using a visual analogue scales (VAS). All participants will wear the vital parameters monitoring system during the entire duration of the tests inside the chamber, as well as the cerebral oxygen saturation (ScO2) sensor. Samples will be collected by saliva, urine and/or capillary blood. The same schedule is repeated in each test session.
* In-field branch: each participant will take part in three research sessions: a familiarization session and two experimental sessions during helicopter flights (test 1 and 2). On test 1 and test 2 each group will be exposed twice to the altitude of 4000 m (under hypobaric hypoxia or hypobaric normoxia conditions) according to the randomization protocol. Participants will perform the neurocognitive test two times on each test: before the ascent (TC0), after around 5 min from the end of the ascent (TC1). After completing each neurocognitive tests, participants will be asked to rate their performance using a visual analogue scales (VAS). All participants will wear the vital parameters monitoring system during the entire duration of the tests. Samples will be collected. The same schedule is planned in each test session.
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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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Hypobaric normoxia
Altitude exposure in hypobaric normoxic condition
Altitude exposure in hypobaric normoxic condition
Altitude exposure with oxygen supplementation to achieve normoxia at altitude
Hypobaric hypoxia
Altitude exposure in hypobaric hypoxic condition
Altitude exposure in hypobaric hypoxic condition
Altitude exposure with air supplementation to obtain a sham comparator arm
Interventions
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Altitude exposure in hypobaric normoxic condition
Altitude exposure with oxygen supplementation to achieve normoxia at altitude
Altitude exposure in hypobaric hypoxic condition
Altitude exposure with air supplementation to obtain a sham comparator arm
Eligibility Criteria
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Inclusion Criteria
* an age between 18 and 60 years;
* an American Society of Anaesthesiologists (ASA) physical status class I;
* provided informed and written consent;
* no current COVID 19 symptoms and temperature ≤ 37.5°on test days, not being tested positive for COVID-19, ideally COVID-19 vaccinated.
Exclusion Criteria
* an ASA physical status class II or more;
* a medical history of psychiatric disorders and neurological diseases;
* previous high altitude pulmonary oedema (HAPE) or high altitude cerebral oedema (HACE) or severe acute mountain sickness (AMS) (defined as a Lake Louise Score (LLS) \> 9) occurred at altitudes similar to the ones tested in the study;
* no informed consent;
* current COVID 19 symptoms, being tested positive for COVID-19 or symptoms and body temperature ≥ 37.5°on test days.
18 Years
60 Years
ALL
Yes
Sponsors
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University Grenoble Alps
OTHER
Università degli Studi di Trento
OTHER
Medical University Innsbruck
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
Marika Falla, MD PhD
Role: PRINCIPAL_INVESTIGATOR
University of Trento, Center for Mind/Brain Sciences - CIMeC
Michiel van Veelen, MD
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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Basner M, Moore TM, Nasrini J, Gur RC, Dinges DF. Standardization of psychomotor vigilance testing methods and reporting. Sleep. 2021 Jul 9;44(7):zsab114. doi: 10.1093/sleep/zsab114. No abstract available.
Brodmann Maeder M, Brugger H, Pun M, Strapazzon G, Dal Cappello T, Maggiorini M, Hackett P, Bartsch P, Swenson ER, Zafren K. The STAR Data Reporting Guidelines for Clinical High Altitude Research. High Alt Med Biol. 2018 Mar;19(1):7-14. doi: 10.1089/ham.2017.0160. Epub 2018 Feb 9.
Cable GG. In-flight hypoxia incidents in military aircraft: causes and implications for training. Aviat Space Environ Med. 2003 Feb;74(2):169-72.
EASA. https://www.easa.europa.eu/document-library/notices-of-proposed-amendment/npa-2018-04. (2018).
Falla M, Papagno C, Dal Cappello T, Vogele A, Hufner K, Kim J, Weiss EM, Weber B, Palma M, Mrakic-Sposta S, Brugger H, Strapazzon G. A Prospective Evaluation of the Acute Effects of High Altitude on Cognitive and Physiological Functions in Lowlanders. Front Physiol. 2021 Apr 28;12:670278. doi: 10.3389/fphys.2021.670278. eCollection 2021.
Falla M, Hufner K, Falk M, Weiss EM, Vogele A, Jan van Veelen M, Weber B, Brandner J, Palma M, Dejaco A, Brugger H, Strapazzon G. Simulated Acute Hypobaric Hypoxia Effects on Cognition in Helicopter Emergency Medical Service Personnel - A Randomized, Controlled, Single-Blind, Crossover Trial. Hum Factors. 2024 Feb;66(2):404-423. doi: 10.1177/00187208221086407. Epub 2022 May 31.
Hart, S., and Staveland, L. (1988). "Development of NASA-TLX (task load index) - results ofempirical and theoretical research," in HumanMental Workload, eds P. Hancock and N. Meshkati (Amsterdam: Springer), 139-183. doi: 10.1016/ s0166- 4115(08)62386- 9.
Hinkelbein J, Glaser E. Evaluation of two oxygen face masks with special regard to inspiratory oxygen fraction (FiO2) for emergency use in rescue helicopters. Air Med J. 2008 Mar-Apr;27(2):86-90. doi: 10.1016/j.amj.2007.07.005.
Mrakic-Sposta S, Vezzoli A, Malacrida S, Falla M, Strapazzon G. "Direct" and "Indirect" Methods to Detect Oxidative Stress During Acute or Chronic High-Altitude Exposure. High Alt Med Biol. 2017 Sep;18(3):303-304. doi: 10.1089/ham.2017.0067. Epub 2017 Jul 28. No abstract available.
Nowacki J, Heekeren HR, Deuter CE, Joerissen JD, Schroder A, Otte C, Wingenfeld K. Decision making in response to physiological and combined physiological and psychosocial stress. Behav Neurosci. 2019 Feb;133(1):59-67. doi: 10.1037/bne0000288. Epub 2018 Dec 17.
Wilson MH, Newman S, Imray CH. The cerebral effects of ascent to high altitudes. Lancet Neurol. 2009 Feb;8(2):175-91. doi: 10.1016/S1474-4422(09)70014-6.
Falla M, van Veelen MJ, Falk M, Weiss EM, Roveri G, Mase M, Weber B, Randi A, Brugger H, Hufner K, Strapazzon G. Effect of oxygen supplementation on cognitive performance among HEMS providers after acute exposure to altitude: the HEMS II randomized clinical trial. Scand J Trauma Resusc Emerg Med. 2024 Jul 29;32(1):65. doi: 10.1186/s13049-024-01238-6.
Other Identifiers
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98-2021
Identifier Type: -
Identifier Source: org_study_id
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