Skip to main content
OpenTrials
Completed

NCT Number: NCT04138446

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hypobaric Hypoxia Cognitive Deterioration Emergency Medicine Resuscitation Stress Physiology

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eurac Research, Institute of Mountain Emergency Medicine

Bolzano, BZ, 39100, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Digit-Symbol Substitution Task - DSST

    Time frame: 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

    Time frame: 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

    Time frame: 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 outcomes

  1. Digit-Symbol Substitution Task - DSST

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: Change from basal measurement (before altitude exposure) to post-altitude measurement (after altitude exposure - 1 hour)

    Changes in TAC in saliva samples (mM)

Sponsors and collaborators

Lead sponsor

Institute of Mountain Emergency Medicine

Other

Collaborators

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

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Oct 24, 2019
Registry last updated
Mar 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.