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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04138446
Enrollment
48
Registered
2019-10-24
Start date
2019-10-25
Completion date
2019-11-11
Last updated
2020-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Deterioration, Emergency Medicine, Hypobaric Hypoxia, Resuscitation, Stress Physiology

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.

Interventions

OTHERAltitude 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.

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)

Intervention model description

Interventional, non-pharmacological, randomized, controlled, single-blinded, cross-over

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Digit-Symbol Substitution Task - DSSTChange 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)
Balloon Analog Risk Test - BARTChange 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)
Psychomotor Vigilance Test - PVTChange 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

MeasureTime frameDescription
Proportion of correct chest compressions regarding depth, pressure point and pressure releaseChanges in 5 minute chest compressionsEvaluation 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)
Digit-Symbol Substitution Task - DSSTChange 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)
Total antioxidant capacity - TACChange from basal measurement (before altitude exposure) to post-altitude measurement (after altitude exposure - 1 hour)Changes in TAC in saliva samples (mM)
Reactive oxygen species - ROSChange from basal measurement (before altitude exposure) to post-altitude measurement (after altitude exposure - 1 hour)Changes in ROS in saliva samples (μmol/min)
Balloon Analog Risk Test - BARTChange 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)
Psychomotor Vigilance Test - PVTChange 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)

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026