ClinicalTrials.Veeva

Menu

Communication Enhancement Among Ventilated Patients in Intensive Care (CESAR)

R

Regional University Hospital Center (CHRU)

Status

Not yet enrolling

Conditions

Critical Care, Intensive Care

Treatments

Other: Communication tool for ventilated patients in intensive care

Study type

Observational

Funder types

Other

Identifiers

NCT07251530
DR250036-CESAR

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

2

Loading...

Central trial contact

Laetitia BODET-CONTENTIN, Doctor; Adrien LOCICIRO, nurse

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems