NCT05078632

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
113

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 7, 2019

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2020

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 23, 2021

Completed
4 months until next milestone

First Posted

Study publicly available on registry

October 14, 2021

Completed
Last Updated

October 14, 2021

Status Verified

October 1, 2021

Enrollment Period

1.6 years

First QC Date

June 23, 2021

Last Update Submit

October 4, 2021

Conditions

Critical Care

Keywords

eye trackingcritical carecomprehension

Outcome Measures

Primary Outcomes (1)

  • Establish eye tracking standards for the test

    fixation time measurement in the defined area of interest

    during hospitalization in intensive care

Study Arms (2)

Healthy volunteers

healthy volunteers

Other: Montreal-Toulouse Test adapted in eye tracking

intensive care patient

patient hospitalized in intensive care unit

Other: Montreal-Toulouse Test adapted in eye tracking

Interventions

Montreal-Toulouse Test adapted in eye trackingOTHER

participant pass an eye tracking test to evaluate comprehension

Healthy volunteersintensive care patient

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy volunteers and patient hospitalized in intensive care unit

You may qualify if:

  • French speaker, RASS (Richmond Agitation-sedation scale) between -1 and +1, agree for participation

You may not qualify if:

  • neurovisual disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Tours

Tours, 37000, France

Location

Study Officials

  • Laetitia BODET-CONTENTIN, MD-PhD

    University Hospital of TOURS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2021

First Posted

October 14, 2021

Study Start

March 7, 2019

Primary Completion

September 25, 2020

Study Completion

September 25, 2020

Last Updated

October 14, 2021

Record last verified: 2021-10

Locations

FR(1)