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

NCT04138446 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2020-03-24

No results posted yet for this study

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.

Conditions

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

Interventions

OTHER

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.

Sponsors & Collaborators

  • Medical University Innsbruck

    collaborator OTHER
  • University of Graz

    collaborator OTHER
  • Università degli Studi di Trento

    collaborator OTHER
  • Azienda Sanitaria dell'Alto Adige

    collaborator OTHER
  • Istituto di Fisiologia Clinica CNR

    collaborator OTHER
  • Institute of Mountain Emergency Medicine

    lead OTHER

Principal Investigators

  • Giacomo Strapazzon, MD PhD · Eurac Research, Institute of Mountain Emergency Medicine

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-10-25
Primary Completion
2019-11-11
Completion
2019-11-11

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04138446 on ClinicalTrials.gov