Critical CareMEXICONCT05078632
Montreal Toulouse Test With Eye Tracking in Intensive Care Unit to Evaluate Comprehension
An observational study of Critical Care, run by University Hospital, Tours at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Critical Care
- What is being tested?
- Montreal-Toulouse Test adapted in eye tracking
- How many people
- 113 participants
- Where
- 1 siteFrance
- Study dates
- 7 Mar 2019to 25 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy volunteers and patient hospitalized in intensive care unit
Who may be able to join
- French speaker, RASS (Richmond Agitation-sedation scale) between -1 and +1, agree for participation
Who cannot join
- neurovisual disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Critical Care
- Being tested
- Montreal-Toulouse Test adapted in eye tracking
- Keywords
- eye tracking, critical care, comprehension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Montreal-Toulouse Test adapted in eye trackingOther
participant pass an eye tracking test to evaluate comprehension
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | healthy volunteers Receives: Other: Montreal-Toulouse Test adapted in eye tracking | |
| intensive care patient | patient hospitalized in intensive care unit Receives: Other: Montreal-Toulouse Test adapted in eye tracking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establish eye tracking standards for the test
fixation time measurement in the defined area of interest
Measured: during hospitalization in intensive care
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2021
- Study start7 Mar 2019
- Primary completion25 Sep 2020
- Study completion25 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical CareStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laetitia BODET-CONTENTIN, MD-PhD, Principal investigator, University Hospital of TOURS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05078632
- Sponsor's protocol ID
- DR190027-MEXICO
- Acronym
- MEXICO
- Status last verified
- Oct 2021
- First submitted
- 23 Jun 2021
- Last updated
- 14 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Montreal Toulouse 86 Test Modified to be Used With Eye Tracking: Test Automation and Eye Course in Healthy Volunteers and Intensive Care Patients
- ClinicalTrials.gov ID
- NCT05078632
- Acronym / sponsor ID
- MEXICO / DR190027-MEXICO
- Conditions
- Critical Care
- Keywords
- eye tracking, critical care, comprehension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 7 Mar 2019 (actual)
- Primary completion
- 25 Sep 2020 (actual)
- Study completion
- 25 Sep 2020 (actual)
- First posted
- 14 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | – | Other: Montreal-Toulouse Test adapted in eye trackinghealthy volunteers |
| intensive care patient | – | Other: Montreal-Toulouse Test adapted in eye trackingpatient hospitalized in intensive care unit |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers and patient hospitalized in intensive care unit
Key inclusion criteria (1 listed)
- French speaker, RASS (Richmond Agitation-sedation scale) between -1 and +1, agree for participation
Key exclusion criteria (1 listed)
- neurovisual disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Montreal-Toulouse Test adapted in eye trackingparticipant pass an eye tracking test to evaluate comprehension | Other | Healthy volunteers, intensive care patient |
Primary outcome
Establish eye tracking standards for the test
Time frame: during hospitalization in intensive care
fixation time measurement in the defined area of interest
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laetitia BODET-CONTENTIN, MD-PhD principal investigator
University Hospital of TOURS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Care, run by University Hospital, Tours at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establish eye tracking standards for the test (time frame: during hospitalization in intensive care). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2021.