跳至主要内容
临床试验/NCT07251530
NCT07251530招募中不适用

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

University Hospital, Tours5 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年3月19日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
5
主要终点
The rate of successful uses of the "JIB-Tours care" device

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

The rate of successful uses of the "JIB-Tours care" device

时间窗: Day 1

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

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (5)

Loading locations...

相似试验