Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The rate of successful uses of the "JIB-Tours care" device | A "successful" use is defined as (cumulative criteria, in chronological order):
| Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 1 |
| Recording of failures according to their occurrence time |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Participants admitted to the Intensive Care Unit of the University Hospital of Tours or Orleans or Le Mans (France)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laetitia BODET-CONTENTIN, Doctor | Contact | 0247479861 | 33 | laetitia.bodet@chu-tours.fr |
| Adrien LOCICIRO, nurse | Contact | adrien_lociciro@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Laetitia BODET-CONTENTIN, MD PhD | Intensive care, University Hospital, Tours | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Intensive care, Hospital, Le MANS | Not yet recruiting | Le Mans | France |
Not provided
| ID | Term |
|---|---|
| D003142 | Communication |
| ID | Term |
|---|---|
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D003422 | Critical Care |
| ID | Term |
|---|---|
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. | 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. | 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). | Day 28 |
| Intensive care, University Hospital, Orléans | Not yet recruiting | Orléans | France |
|
| Intensive care, University Hospital | Recruiting | Tours | 37000 | France |
|