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
About this trial
This is an interventional basic science trial for Hypobaric Hypoxia
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
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
NCT ID
NCT04138446
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
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
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Results Reference
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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
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PubMed Identifier
29789086
Citation
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Results Reference
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PubMed Identifier
26564759
Citation
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Results Reference
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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
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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
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Effects of Acute Hypobaric Hypoxia Exposure on Neurocognitive Performance of Pre-hospital Emergency Service Providers
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