Communication Enhancement Among Ventilated Patients in Intensive Care
ConditionCritical Care, Intensive Care
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Tours
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Intubated ventilated ICU patient
Hospitalized patient with an inflated cuff tracheostomy
conscious patient, able to open and close eyes on demand
of-age patient
Disqualifiers
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 population
Participants admitted to the Intensive Care Unit of the University Hospital of Tours or Orleans or Le Mans (France)
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Communication tool for ventilated patients in intensive care
Other interventionThe 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.
Treatment groups
No treatment groups listed
Trial outcomes
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
Time frame
Day 1Secondary outcomes
1
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.
Time frame
Day 12
Recording of failures according to their occurrence time
* Failure to start the tool * Failure of the mobility test * Failure to set up the patient * Failure of calibration * Failure to complete the comprehension test * Failure to transition to the adapted interface * Failure of communication interface operation * Failure during the procedure: * Failure due to interruption caused by patient's health status at any point in the procedure, other than a comprehension test result preventing interface proposal
Time frame
Day 13
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.
Time frame
Day 14
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.
Time frame
Day 28Sponsors and contacts
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Source ClinicalTrials.gov