Communication Enhancement Among Ventilated Patients in Intensive Care

NCT ID: NCT07251530

Last Updated: 2025-11-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-12-02
• Study Completion Date: 2026-06-01

Brief 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. 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.

Conditions

Critical Care, Intensive Care

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Tours

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laetitia BODET-CONTENTIN, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Intensive care, University Hospital, Tours

Locations

Intensive care, Hospital, Le MANS

Le Mans, , France

Intensive care, University Hospital, Orléans

Orléans, , France

Countries

France

Central Contacts

Laetitia BODET-CONTENTIN, Doctor

Role: CONTACT

laetitia.bodet@chu-tours.fr

0247479861 ext. 33

Adrien LOCICIRO, nurse

Role: CONTACT

adrien_lociciro@hotmail.com

Facility Contacts

Nicolas CHUDEAU, MD

Role: primary

François BARBIER, MD

Role: primary

Other Identifiers

DR250036-CESAR

Identifier Type: -

Identifier Source: org_study_id