- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05078632
Montreal Toulouse Test With Eye Tracking in Intensive Care Unit to Evaluate Comprehension (MEXICO)
October 4, 2021 updated by: University Hospital, Tours
Montreal Toulouse 86 Test Modified to be Used With Eye Tracking: Test Automation and Eye Course in Healthy Volunteers and Intensive Care Patients
Assessment of the level of oral comprehension of the intensive care patient is essential to improve their care because they have often troubles like delirium.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Assessment of the level of oral comprehension of the intensive care patient is essential to improve their care because they have often troubles like delirium.
Study Type
Observational
Enrollment (Actual)
113
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
-
-
-
Tours, France, 37000
- CHU Tours
-
-
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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Healthy volunteers and patient hospitalized in intensive care unit
Description
Inclusion Criteria:
- French speaker, RASS (Richmond Agitation-sedation scale) between -1 and +1, agree for participation
Exclusion Criteria:
- neurovisual disorders
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Healthy volunteers
healthy volunteers
|
participant pass an eye tracking test to evaluate comprehension
|
|
intensive care patient
patient hospitalized in intensive care unit
|
participant pass an eye tracking test to evaluate comprehension
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Establish eye tracking standards for the test
Time Frame: during hospitalization in intensive care
|
fixation time measurement in the defined area of interest
|
during hospitalization in intensive care
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Laetitia BODET-CONTENTIN, MD-PhD, University hospital of Tours
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)
March 7, 2019
Primary Completion (Actual)
September 25, 2020
Study Completion (Actual)
September 25, 2020
Study Registration Dates
First Submitted
June 23, 2021
First Submitted That Met QC Criteria
October 4, 2021
First Posted (Actual)
October 14, 2021
Study Record Updates
Last Update Posted (Actual)
October 14, 2021
Last Update Submitted That Met QC Criteria
October 4, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- DR190027-MEXICO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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.
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