Communication Enhancement Among Ventilated Patients in Intensive Care

NCT07251530 | Recruiting

• 1 other identifier: DR250036-CESAR
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 3

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.

Conditions

Critical Care, Intensive Care

Keywords

communication; critical care; Augmentative and Alternative Communications Systems

Outcome Measures

Primary Outcomes (1)

• 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

  Day 1

Secondary Outcomes (5)

• Duration of device setup in front of the patient

  Day 1

• Recording of failures according to their occurrence time

  Day 1

• Communication success rate

  Day 1

• Collection of device improvement suggestions through a feedback questionnaire from users (caregivers, patients, and relatives)

  Day 28

• User satisfaction (patients, relatives, and caregivers) with the use of the "JIB-Tours care" device

  Day 28

Interventions

Communication tool for ventilated patients in intensive care OTHER

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants admitted to the Intensive Care Unit of the University Hospital of Tours or Orleans or Le Mans (France)

You may qualify if:

• 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

You may not qualify if:

• Patient with uncorrected visual impairment or hearing deficiency
• opposed to the processing of personal data

Sponsors & Collaborators

• University Hospital, Tours: lead

Study Sites (3)

Intensive care, Hospital, Le MANS

Le Mans, France

NOT YET RECRUITING

Intensive care, University Hospital, Orléans

Orléans, France

NOT YET RECRUITING

Intensive care, University Hospital

Tours, 37000, France

RECRUITING

MeSH Terms

Conditions

Communication

Interventions

Critical Care

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Laetitia BODET-CONTENTIN, MD PhD

  Intensive care, University Hospital, Tours

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laetitia BODET-CONTENTIN, Doctor

CONTACT

0247479861; laetitia.bodet@chu-tours.fr

Adrien LOCICIRO, nurse

CONTACT

adrien_lociciro@hotmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2025
• First Posted: November 26, 2025
• Study Start: March 19, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-04

Locations

FR (3)