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

Not Applicable

Completed

• Conditions: Cognitive Deterioration; Emergency Medicine; Hypobaric Hypoxia; Resuscitation; Stress Physiology
• Interventions: Other: Altitude exposure in climate chamber

• Registration Number: NCT04138446
• Lead Sponsor: Institute of Mountain Emergency Medicine

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-18
• Study First Submitted QC: 2019-10-22
• Study First Posted: 2019-10-24
• Study Start: 2019-10-25
• Primary Completion: 2019-11-11
• Study Completion: 2019-11-11
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-23
• Last Update Posted: 2020-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
200-5000	Altitude exposure in climate chamber	Day 1: 200m asl Day 2: 5000m asl
200-3000	Altitude exposure in climate chamber	Day 1: 200m (above sea level) asl Day 2: 3000m asl
3000-200	Altitude exposure in climate chamber	Day 1: 3000m asl Day 2: 200m asl
3000-5000	Altitude exposure in climate chamber	Day 1: 3000m asl Day 2: 5000m asl
5000-3000	Altitude exposure in climate chamber	Day 1: 5000m asl Day 2: 3000m asl
5000-200	Altitude exposure in climate chamber	Day 1: 5000m asl Day 2: 200m asl

Primary Outcome Measures

Name	Time	Method
Digit-Symbol Substitution Task - DSST	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)
Psychomotor Vigilance Test - PVT	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)
Balloon Analog Risk Test - BART	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)

Secondary Outcome Measures

Name	Time	Method
Balloon Analog Risk Test - BART	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)
Digit-Symbol Substitution Task - DSST	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)
Proportion of correct chest compressions regarding depth, pressure point and pressure release	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)
Psychomotor Vigilance Test - PVT	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)
Reactive oxygen species - ROS	Change from basal measurement (before altitude exposure) to post-altitude measurement (after altitude exposure - 1 hour)	Changes in ROS in saliva samples (μmol/min)
Total antioxidant capacity - TAC	Change from basal measurement (before altitude exposure) to post-altitude measurement (after altitude exposure - 1 hour)	Changes in TAC in saliva samples (mM)

Trial Locations

Locations (1)

Eurac Research, Institute of Mountain Emergency Medicine; 🇮🇹 Bolzano, BZ, Italy