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

Primary Purpose

Hypobaric Hypoxia, Cognitive Deterioration, Emergency Medicine

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Altitude exposure in climate chamber
Sponsored by
Institute of Mountain Emergency Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hypobaric Hypoxia

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Eurac Research, Institute of Mountain Emergency Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Active Comparator

Arm Label

200-3000

3000-200

200-5000

5000-200

3000-5000

5000-3000

Arm Description

Day 1: 200m (above sea level) asl Day 2: 3000m asl

Day 1: 3000m asl Day 2: 200m asl

Day 1: 200m asl Day 2: 5000m asl

Day 1: 5000m asl Day 2: 200m asl

Day 1: 3000m asl Day 2: 5000m asl

Day 1: 5000m asl Day 2: 3000m asl

Outcomes

Primary Outcome Measures

Digit-Symbol Substitution Task - DSST
Changes in working memory at altitude using a computer-based test (DSST)
Balloon Analog Risk Test - BART
Changes in risk-taking behavior at altitude using a computer-based test (BART)
Psychomotor Vigilance Test - PVT
Changes in reaction time using a computer-based test (PVT)

Secondary Outcome Measures

Digit-Symbol Substitution Task - DSST
Changes in working memory after exercise at altitude using a computer-based test (DSST)
Balloon Analog Risk Test - BART
Changes in risk-taking behavior after exercise at altitude using a computer-based test (BART)
Psychomotor Vigilance Test - PVT
Changes in reaction time after exercise at altitude using a computer-based test battery (PVT)
Proportion of correct chest compressions regarding depth, pressure point and pressure release
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)
Reactive oxygen species - ROS
Changes in ROS in saliva samples (μmol/min)
Total antioxidant capacity - TAC
Changes in TAC in saliva samples (mM)

Full Information

First Posted
October 18, 2019
Last Updated
March 23, 2020
Sponsor
Institute of Mountain Emergency Medicine
Collaborators
Medical University Innsbruck, University of Graz, Università degli Studi di Trento, Azienda Sanitaria dell'Alto Adige, Istituto di Fisiologia Clinica CNR
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1. Study Identification

Unique Protocol Identification Number
NCT04138446
Brief Title
Effects of Acute Hypobaric Hypoxia Exposure on Neurocognitive Performance of Pre-hospital Emergency Service Providers
Official Title
Effects of Acute Hypobaric Hypoxia Exposure on Neurocognitive Performance of Pre-hospital Emergency Service Providers
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
October 25, 2019 (Actual)
Primary Completion Date
November 11, 2019 (Actual)
Study Completion Date
November 11, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institute of Mountain Emergency Medicine
Collaborators
Medical University Innsbruck, University of Graz, Università degli Studi di Trento, Azienda Sanitaria dell'Alto Adige, Istituto di Fisiologia Clinica CNR

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypobaric Hypoxia, Cognitive Deterioration, Emergency Medicine, Resuscitation, Stress Physiology

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Interventional, non-pharmacological, randomized, controlled, single-blinded, cross-over
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
200-3000
Arm Type
Experimental
Arm Description
Day 1: 200m (above sea level) asl Day 2: 3000m asl
Arm Title
3000-200
Arm Type
Experimental
Arm Description
Day 1: 3000m asl Day 2: 200m asl
Arm Title
200-5000
Arm Type
Experimental
Arm Description
Day 1: 200m asl Day 2: 5000m asl
Arm Title
5000-200
Arm Type
Experimental
Arm Description
Day 1: 5000m asl Day 2: 200m asl
Arm Title
3000-5000
Arm Type
Experimental
Arm Description
Day 1: 3000m asl Day 2: 5000m asl
Arm Title
5000-3000
Arm Type
Active Comparator
Arm Description
Day 1: 5000m asl Day 2: 3000m asl
Intervention Type
Other
Intervention Name(s)
Altitude exposure in climate chamber
Intervention Description
Altitude exposure in a climate chamber will consist of hypobaric hypoxia similar to the conditions found at 3000m asl and 5000m asl.
Primary Outcome Measure Information:
Title
Digit-Symbol Substitution Task - DSST
Description
Changes in working memory at altitude using a computer-based test (DSST)
Time Frame
Change from basal measurement (before altitude exposure) to altitude measurement (after altitude exposure - 5 minutes)
Title
Balloon Analog Risk Test - BART
Description
Changes in risk-taking behavior at altitude using a computer-based test (BART)
Time Frame
Change from basal measurement (before altitude exposure) to altitude measurement (after altitude exposure - 5 minutes)
Title
Psychomotor Vigilance Test - PVT
Description
Changes in reaction time using a computer-based test (PVT)
Time Frame
Change from basal measurement (before altitude exposure) to altitude measurement (after altitude exposure - 5 minutes)
Secondary Outcome Measure Information:
Title
Digit-Symbol Substitution Task - DSST
Description
Changes in working memory after exercise at altitude using a computer-based test (DSST)
Time Frame
Change from rest measurement (altitude exposure before chest compressions) to post-exercise measurement (after 5 minutes of chest compressions at altitude)
Title
Balloon Analog Risk Test - BART
Description
Changes in risk-taking behavior after exercise at altitude using a computer-based 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)
Title
Psychomotor Vigilance Test - PVT
Description
Changes in reaction time after exercise at altitude using a computer-based test battery (PVT)
Time Frame
Change from rest measurement (altitude exposure before chest compressions) to post-exercise measurement (after 5 minutes of chest compressions at altitude)
Title
Proportion of correct chest compressions regarding depth, pressure point and pressure release
Description
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)
Time Frame
Changes in 5 minute chest compressions
Title
Reactive oxygen species - ROS
Description
Changes in ROS in saliva samples (μmol/min)
Time Frame
Change from basal measurement (before altitude exposure) to post-altitude measurement (after altitude exposure - 1 hour)
Title
Total antioxidant capacity - TAC
Description
Changes in TAC in saliva samples (mM)
Time Frame
Change from basal measurement (before altitude exposure) to post-altitude measurement (after altitude exposure - 1 hour)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giacomo Strapazzon, MD PhD
Organizational Affiliation
Eurac Research, Institute of Mountain Emergency Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eurac Research, Institute of Mountain Emergency Medicine
City
Bolzano
State/Province
BZ
ZIP/Postal Code
39100
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All of the individual participant data collected during the trial, after deidentification
IPD Sharing Time Frame
Data will be available within 6 months from study completion
IPD Sharing Access Criteria
Access will be granted to primary collaborators who will be required to sign a Data Access agreement
Citations:
PubMed Identifier
26779029
Citation
Taylor L, Watkins SL, Marshall H, Dascombe BJ, Foster J. The Impact of Different Environmental Conditions on Cognitive Function: A Focused Review. Front Physiol. 2016 Jan 6;6:372. doi: 10.3389/fphys.2015.00372. eCollection 2015.
Results Reference
background
PubMed Identifier
30760298
Citation
Pietsch U, Strapazzon G, Ambuhl D, Lischke V, Rauch S, Knapp J. Challenges of helicopter mountain rescue missions by human external cargo: need for physicians onsite and comprehensive training. Scand J Trauma Resusc Emerg Med. 2019 Feb 13;27(1):17. doi: 10.1186/s13049-019-0598-2.
Results Reference
background
PubMed Identifier
11892743
Citation
Li XY, Wu XY, Fu C, Shen XF, Yang CB, Wu YH. Effects of acute exposure to mild or moderate hypoxia on human psychomotor performance and visual-reaction time. Space Med Med Eng (Beijing). 2000 Aug;13(4):235-9.
Results Reference
background
PubMed Identifier
29789086
Citation
Bouak F, Vartanian O, Hofer K, Cheung B. Acute Mild Hypoxic Hypoxia Effects on Cognitive and Simulated Aircraft Pilot Performance. Aerosp Med Hum Perform. 2018 Jun 1;89(6):526-535. doi: 10.3357/AMHP.5022.2018.
Results Reference
background
PubMed Identifier
26564759
Citation
Basner M, Savitt A, Moore TM, Port AM, McGuire S, Ecker AJ, Nasrini J, Mollicone DJ, Mott CM, McCann T, Dinges DF, Gur RC. Development and Validation of the Cognition Test Battery for Spaceflight. Aerosp Med Hum Perform. 2015 Nov;86(11):942-52. doi: 10.3357/AMHP.4343.2015.
Results Reference
background
PubMed Identifier
25154345
Citation
Wang JC, Tsai SH, Chen YL, Hsu CW, Lai KC, Liao WI, Li LY, Kao WF, Fan JS, Chen YH. The physiological effects and quality of chest compressions during CPR at sea level and high altitude. Am J Emerg Med. 2014 Oct;32(10):1183-8. doi: 10.1016/j.ajem.2014.07.007. Epub 2014 Jul 30.
Results Reference
background
PubMed Identifier
34854317
Citation
Vogele A, van Veelen MJ, Dal Cappello T, Falla M, Nicoletto G, Dejaco A, Palma M, Hufner K, Brugger H, Strapazzon G. Effect of Acute Exposure to Altitude on the Quality of Chest Compression-Only Cardiopulmonary Resuscitation in Helicopter Emergency Medical Services Personnel: A Randomized, Controlled, Single-Blind Crossover Trial. J Am Heart Assoc. 2021 Dec 7;10(23):e021090. doi: 10.1161/JAHA.121.021090. Epub 2021 Dec 2.
Results Reference
derived

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

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