Critical Care, Intensive CareCESARNCT07251530
Communication Enhancement Among Ventilated Patients in Intensive Care
An observational study of Critical Care, Intensive Care, run by University Hospital, Tours at 3 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Care, Intensive Care
- What is being tested?
- Communication tool for ventilated patients in intensive care
- Type of treatment
- Pill or oral medicine
- How many people
- 60 participants
- Where
- 3 sitesFrance
- Study dates
- 19 Mar 2026to 1 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: Participants admitted to the Intensive Care Unit of the University Hospital of Tours or Orleans or Le Mans (France)
Who may be able to join
- Intubated ventilated ICU patient
- Hospitalized patient with an inflated cuff tracheostomy
- conscious patient, able to open and close eyes on demand
- of-age patient
- French speaking
Who cannot join
- Patient with uncorrected visual impairment or hearing deficiency
- Known guardianship or trusteeship at the time of inclusion
- Known pregnant women at the time of inclusion and lactating patients
- opposed to the processing of personal data
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Adrien LOCICIRO, nurse contact
France3 sites, 3 recruiting
- Not yet recruiting
Intensive care, Hospital, Le MANS
Le Mans
Nicolas CHUDEAU, MD
Nicolas CHUDEAU, MD
- Not yet recruiting
Intensive care, University Hospital, Orléans
Orléans
François BARBIER, MD
François BARBIER, MD
- Recruiting
Intensive care, University Hospital
Tours, 37000
Laetitia BODET CONTENTIN, Doctor, 0247479861, laetitia.bodet@chu-tours.fr
About this study
Official title: Communication Enhancement Among Ventilated Patients in Intensive Care : Feasibility of Implementing "JIB-TourS cARe" High Technology Device With Eye Tracker
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.
Read the detailed description
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.
- Conditions
- Critical Care, Intensive Care
- Being tested
- Communication tool for ventilated patients in intensive care
- Keywords
- communication, critical care, Augmentative and Alternative Communications Systems
- Medical subject headings
- Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Communication tool for ventilated patients in intensive careOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 1
Secondary outcomes (5)
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start19 Mar 2026
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical Care, Intensive 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
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, Intensive care, University Hospital, Tours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07251530
- Sponsor's protocol ID
- DR250036-CESAR
- Acronym
- CESAR
- Status last verified
- Apr 2026
- First submitted
- 24 Jul 2025
- Last updated
- 4 May 2026
- 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 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Communication Enhancement Among Ventilated Patients in Intensive Care : Feasibility of Implementing "JIB-TourS cARe" High Technology Device With Eye Tracker
- ClinicalTrials.gov ID
- NCT07251530
- Acronym / sponsor ID
- CESAR / DR250036-CESAR
- Conditions
- Critical Care, Intensive Care
- Keywords
- communication, critical care, Augmentative and Alternative Communications Systems
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 19 Mar 2026 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 26 Nov 2025 (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.
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.
Detailed description
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants admitted to the Intensive Care Unit of the University Hospital of Tours or Orleans or Le Mans (France)
Key inclusion criteria (5 listed)
- Intubated ventilated ICU patient
- Hospitalized patient with an inflated cuff tracheostomy
- conscious patient, able to open and close eyes on demand
- of-age patient
- French speaking
Key exclusion criteria (4 listed)
- Patient with uncorrected visual impairment or hearing deficiency
- Known guardianship or trusteeship at the time of inclusion
- Known pregnant women at the time of inclusion and lactating patients
- opposed to the processing of personal data
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 |
|---|---|---|
| Communication tool for ventilated patients in intensive careThe 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. | Other | – |
Primary outcome
The rate of successful uses of the "JIB-Tours care" device
Time frame: Day 1
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
5 secondary outcomes
Duration of device setup in front of the patient
Time frame: Day 1
Recording of failures according to their occurrence time
Time frame: Day 1
Communication success rate
Time frame: Day 1
Collection of device improvement suggestions through a feedback questionnaire from users (caregivers, patients, and relatives)
Time frame: Day 28
User satisfaction (patients, relatives, and caregivers) with the use of the "JIB-Tours care" device
Time frame: Day 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
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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.
Adrien LOCICIRO, nurse contact
Laetitia BODET-CONTENTIN, MD PhD principal investigator
Intensive care, University Hospital, Tours
3 sites 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, Intensive Care, run by University Hospital, Tours at 3 sites 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 5 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laetitia BODET-CONTENTIN, Doctor (0247479861 ext. 33, laetitia.bodet@chu-tours.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of successful uses of the "JIB-Tours care" device (time frame: Day 1). 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 4 May 2026.