An observational study in Critical Care, Intensive Care, sponsored by University Hospital, Tours. Recruiting at 3 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-04.
Sponsored by University Hospital, Tours · Observational
Intensive care is a unit that admits ventilated patients. Hospitalization is extremely challenging for these patients. Their vital prognosis is at stake, and they often have difficulty moving due to pain, edema, neuromyopathy, or the presence of monitoring cables. They are also hindered in their communication: they cannot speak because of the presence of the intubation tube between their vocal cords or the tracheostomy cannula with the inflated cuff. Every day, in each intensive care unit, about 50% of ventilated patients are conscious and face communication difficulties. They describe this difficulty as a "nightmare." This leads to challenges in care management and increases the anxiety caused by hospitalization in the intensive care unit. A large proportion of patients will develop post-intensive care syndrome. The tools currently used are not efficient. Moreover, many patients have comprehension difficulties due to the medications administered to them (sedatives) or due to the initial or secondary pathologies related to their hospitalization (confusional syndrome, ICU delirium).
Our objective is to implement an adapted and personalized communication tool for ventilated patients in intensive care.
The innovative device "JIB-Tours care" is equipped with a tablet featuring eye-tracking control and software specifically dedicated to communication in an intensive care unit. The eye-tracking control allows the tablet to be used with the gaze, similar to how a computer mouse is usually used. The "JIB-Tours care" system first performs a test to assess the patient's level of understanding by analyzing eye movements. The result, provided at the end of the test, then allows the proposal of a communication interface adapted to the patient's level of understanding. Three interfaces will be available. JIB-Tours care was co-designed by intensive care healthcare professionals in collaboration with former intensive care patients and their relatives. Our objective is to evaluate the feasibility and functionality of JIB-Tours care, meaning its implementation with the patient, the completion of the understanding level test, the automated transition to the adapted communication interface, and the successful use with a message delivered by the patient in accordance with their wish.
719 studies on the registry are indexed under Communication; 159 are open to participants now.
This study's planned enrollment of 60 is below the median of 104 across 132 observational studies indexed under Communication.
Browse Communication studies →University Hospital, Tours is the lead sponsor of 307 studies on the registry; 79 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Participants admitted to the Intensive Care Unit of the University Hospital of Tours or Orleans or Le Mans (France)
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
The innovative device "JIB-Tours care" is equipped with a tablet featuring eye-tracking control and software specifically dedicated to communication in an intensive care unit. The eye-tracking control allows the tablet to be used with the gaze, similar to how a computer mouse is usually used.
The rate of successful uses of the "JIB-Tours care" device
A "successful" use is defined as (cumulative criteria, in chronological order): * Activation of the device by the caregiver * Completion of the mobility questionnaire * Setup of the device in front of the eligible patient * Successful calibration of the eye-tracking control * Completion of the comprehension assessment test * Transition to the adapted communication interface * Use of the communication interface by the patient by clicking on the icon requested by the caregiver
Time frame: Day 1
Duration of device setup in front of the patient
This time measurement will start when the device enters the patient's room and end when the patient clicks on the requested icon. It will be timed by an independent observer.
Time frame: Day 1
Recording of failures according to their occurrence time
* Failure to start the tool * Failure of the mobility test * Failure to set up the patient * Failure of calibration * Failure to complete the comprehension test * Failure to transition to the adapted interface * Failure of communication interface operation * Failure during the procedure: * Failure due to interruption caused by patient's health status at any point in the procedure, other than a comprehension test result preventing interface proposal
Time frame: Day 1
Communication success rate
"Communication success" rate, meaning the patient successfully conveyed the intended message. The independent observer will evaluate the first message transmitted by the patient (immediately after responding to the caregiver's request to click on an icon), right after interaction with the care team. This criterion will be collected by asking the patient: "Did you succeed in conveying the information you wished to transmit?" The answer is binary: yes or no, and can be communicated by blinking, nodding, or hand squeeze. This evaluation will focus on the first message sent using the "JIB-Tours care" device.
Time frame: Day 1
Collection of device improvement suggestions through a feedback questionnaire from users (caregivers, patients, and relatives)
The independent observer will conduct individual, recorded, semi-structured interviews with patients after they have regained speech following extubation or the ability to use a phonation valve, and before discharge from intensive care. For caregivers and relatives, the semi-structured interview will be conducted immediately after device use by the independent observer. A qualitative analysis of the interviews, especially the verbatim responses, will be performed.
Time frame: Day 28
User satisfaction (patients, relatives, and caregivers) with the use of the "JIB-Tours care" device
After device use, the independent observer will present users with a scale of 4 emoticons ranging from a least smiling face to a very smiling face. The observer will ask each user to choose the emoticon that best represents their level of satisfaction with the device. The result will be recorded by the independent observer in the Case Report Form (CRF), scored from 1 (least smiling emoticon) to 4 (most smiling emoticon).
Time frame: Day 28
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.