Communication Enhancement Among Ventilated Patients in Intensive Care

Официальное название

Communication Enhancement Among Ventilated Patients in Intensive Care : Feasibility of Implementing "JIB-TourS cARe" High Technology Device With Eye Tracker

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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.

Первичные конечные точки

• The rate of successful uses of the "JIB-Tours care" device [Срок оценки: Day 1]

Вторичные конечные точки (5)

• Duration of device setup in front of the patient [Срок оценки: Day 1]
• Recording of failures according to their occurrence time [Срок оценки: Day 1]
• Communication success rate [Срок оценки: Day 1]
• Collection of device improvement suggestions through a feedback questionnaire from users (caregivers, patients, and relatives) [Срок оценки: Day 28]
• User satisfaction (patients, relatives, and caregivers) with the use of the "JIB-Tours care" device [Срок оценки: Day 28]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Только случаи

Центры проведения

Франция · 3 центра

• Intensive care, Hospital, Le MANS — Le Mans
• Intensive care, University Hospital, Orléans — Orléans
• Intensive care, University Hospital — Tours

Идентификаторы

NCT: NCT07251530 · DR250036-CESAR

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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