Cognition at Altitude in HEMS - Part II (HEMS II)

February 28, 2023 updated by: Giacomo Strapazzon, MD PhD, Institute of Mountain Emergency Medicine

Cognitive Performance After Acute Exposure to Altitude - Part II

The aim of the current study is to evaluate under blinded conditions, both in a simulated environment and during helicopter flight, the effect of a rapid (within 20 minutes) exposure to altitude (4000 m asl) on physiological parameters and selected cognitive domains, in providers operating in helicopter emergency medical service (HEMS) exposed to hypobaric hypoxia or to hypobaric normoxia (H0: cognitive effects under hypobaric hypoxia = cognitive effects under hypobaric normoxia). Simulated environment will allow to control different factors. The parallelism between a study branch conducted in a simulated environment and another one conducted under a real-life condition will allow to evaluate the additive effects on additional stressor factors (processive and systemic ones).

  • Simulation branch: each participant will take part in three research sessions: a familiarization session and two experimental sessions in simulation facility called terraXcube (test 1 and 2). On test 1 and test 2 each group will be exposed twice to the simulated altitude of 4000 m asl (under hypobaric hypoxia or hypobaric normoxia conditions) according to the randomization protocol. Participants will perform the neurocognitive tests three times on each of the two tests: before the ascent (TC0), after 5 min from the end of the ascent (TC1) and after around 30 min (TC2), to investigate European Union Aviation Safe Agency (EASA) proposed recommendations. After completing each neurocognitive test session, participants will be asked to rate their performance using a visual analogue scales (VAS). All participants will wear the vital parameters monitoring system during the entire duration of the tests inside the chamber, as well as the cerebral oxygen saturation (ScO2) sensor. Samples will be collected by saliva, urine and/or capillary blood. The same schedule is repeated in each test session.
  • In-field branch: each participant will take part in three research sessions: a familiarization session and two experimental sessions during helicopter flights (test 1 and 2). On test 1 and test 2 each group will be exposed twice to the altitude of 4000 m (under hypobaric hypoxia or hypobaric normoxia conditions) according to the randomization protocol. Participants will perform the neurocognitive test two times on each test: before the ascent (TC0), after around 5 min from the end of the ascent (TC1). After completing each neurocognitive tests, participants will be asked to rate their performance using a visual analogue scales (VAS). All participants will wear the vital parameters monitoring system during the entire duration of the tests. Samples will be collected. The same schedule is planned in each test session.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • BZ
      • Bolzano, BZ, Italy, 39100
        • Eurac research, Institute of mountain emergency medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • members of emergency medical services (EMS) and search and rescue (SAR) services with an occupational licence;
  • an age between 18 and 60 years;
  • an American Society of Anaesthesiologists (ASA) physical status class I;
  • provided informed and written consent;
  • no current COVID 19 symptoms and temperature ≤ 37.5°on test days, not being tested positive for COVID-19, ideally COVID-19 vaccinated.

Exclusion Criteria:

  • members under the age of 18 years;
  • an ASA physical status class II or more;
  • a medical history of psychiatric disorders and neurological diseases;
  • previous high altitude pulmonary oedema (HAPE) or high altitude cerebral oedema (HACE) or severe acute mountain sickness (AMS) (defined as a Lake Louise Score (LLS) > 9) occurred at altitudes similar to the ones tested in the study;
  • no informed consent;
  • current COVID 19 symptoms, being tested positive for COVID-19 or symptoms and body temperature ≥ 37.5°on test days.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hypobaric normoxia
Altitude exposure in hypobaric normoxic condition
Other: Altitude exposure in hypobaric normoxic condition
Altitude exposure with oxygen supplementation to achieve normoxia at altitude
Sham Comparator: Hypobaric hypoxia
Altitude exposure in hypobaric hypoxic condition
Other: Altitude exposure in hypobaric hypoxic condition
Altitude exposure with air supplementation to obtain a sham comparator arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Psychomotor Vigilance Test - PVT
Time Frame: Changes from baseline (T0) to altitude measurement (respectively after 5 min - T1 and after 30 min - T2)
Changes in reaction time using a computer-based test (PVT)
Changes from baseline (T0) to altitude measurement (respectively after 5 min - T1 and after 30 min - T2)
Digit-Symbol Substitution Task - DSST
Time Frame: Changes from baseline (TC0) to altitude measurement (respectively after 5 min - TC1 and after 30 min - TC2)
Changing in processing speed using a computer based test (DSST)
Changes from baseline (TC0) to altitude measurement (respectively after 5 min - TC1 and after 30 min - TC2)
2-back Test
Time Frame: Changes from baseline (TC0) to altitude measurement (respectively after 5 min - TC1 and after 30 min - TC2)
Changing in working memory using a computer based test (2-back test)
Changes from baseline (TC0) to altitude measurement (respectively after 5 min - TC1 and after 30 min - TC2)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Mountain Emergency Medicine

Collaborators

Medical University Innsbruck
University Grenoble Alps
Università degli Studi di Trento

Investigators

  • Principal Investigator: Giacomo Strapazzon, MD PhD, Eurac research, Institute of mountain emergency medicine
  • Principal Investigator: Marika Falla, MD PhD, University of Trento, Center for Mind/Brain Sciences - CIMeC
  • Principal Investigator: Michiel van Veelen, MD, Eurac research, Institute of mountain emergency medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2021

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

September 29, 2021

First Submitted That Met QC Criteria

September 29, 2021

First Posted (Actual)

October 11, 2021

Study Record Updates

Last Update Posted (Actual)

March 1, 2023

Last Update Submitted That Met QC Criteria

February 28, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 98-2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Emergency Medicine

Clinical Trials on Altitude exposure in hypobaric normoxic condition

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Spain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe