Eye-Tracking Interactive Agent in Non-verbal ICU Patients
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai Zhongshan Hospital
About this trial
The goal of this clinical trial is to determine whether an eye-tracking interactive agent can ameliorate communication impairments and reduce the incidence of complications among non-verbal patients in the intensive care unit (ICU). The main questions it aims to answer are:
Does the eye tracking interactive agent alleviate communication impairments among non-verbal patients in the ICU? Does the eye tracking interactive agent improve communication efficiency among non-verbal patients in the ICU? Does the eye tracking interactive agent m reduce the incidence of negative emotions among non-verbal patients in the ICU? Does the eye tracking interactive agent shorten the ICU length of stay for non-verbal patients in the ICU? Does the eye tracking interactive agent reduce the dosage of analgesic and sedative medications for non-verbal patients in the ICU? Does the eye tracking interactive agent improve family satisfaction for non-verbal patients in the ICU? Does the eye tracking interactive agent alleviate nurses' communication burden among non-verbal patients in the ICU? Researchers will compare eye tracking interactive agent to conventional techniques to see if e eye tracking interactive agent works to alleviate communication impairments.
Participants will:
Use an eye tracking interactive agent for augmentative communication for 2 consecutive days Document each communication's details, ICU LOS, and analgesic-sedative dosages; assess communication difficulty severity, delirium, anxiety, family satisfaction and nurses' communication burden with validated scales.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged ≥ 18 years
Patients in the ICU who are unable to communicate through normal verbal means due to endotracheal intubation/tracheotomy, muscle or nerve injury, acute/chronic spinal cord injury, etc.
Richmond Agitation-Sedation Scale (RASS) score of -1 to 1
Primary caregivers are adults
Disqualifiers
Diseases associated with cognitive impairment, such as pulmonary encephalopathy, hepatic encephalopathy, diabetic hyperosmolar coma, and coma of unknown cause
A history of mental disorders, dementia or pre-dementia, or intellectual disability
Conditions precluding cooperation with eye-tracking interaction, such as blindness or inability to elevate the eyelids.
Trial design
Design model
Parallel
Treatments tested in this trial
eye-tracking interactive agent
DeviceThe eye-tracking interactive agent consists of an eye-tracker, an iPad, and a floor-standing stand. Positioned at the patient's bedside, the system is activated upon the patient's eye opening, allowing the patient to vocalize via this eye-tracking interactive system.
conventional techniques
Other interventionNurses communicate with patients through verbal inquiry, hand gestures, head nods or shakes, and simple paper-and-pencil tools; patients unable to write communicate solely via body language. Needs are guessed only when patients exhibit obvious discomfort.
Treatment groups
54 Participants
are divided into 2 treatment groupsGroup A: eye-tracking groupExperimental treatment 1 intervention
Group B: conventional techniques groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Communication difficulty
The degree of communication difficulty in non-verbal ICU patients will be assessed using the Ease of Communication Scale. This tool was revised by Menzel et al. in 1998 and has previously been used to assess communication difficulties among non-verbal patients in the ICU. The scale comprises 6 items, with response options ranging from 0 (no difficulty at all) to 4 (extreme difficulty). The total score ranges from 0 to 24, with higher scores indicating greater communication difficulties.
Time frame
up to 2days after enrollmentSecondary outcomes
1
Communication efficiency
the number of successful communications within 24 hours
Time frame
up to 2 days after enrollment2
Anxiety
Anxiety level will be measured using the Faces Anxiety Scale. This is a single-item scale with five response options, ranging from neutral expression (1 point) to extreme anxiety (5 points).
Time frame
at 4:00 PM daily3
Delirium-free days
Delirium-free days refer to the total number of complete calendar days without delirium during the ICU stay.
Time frame
through discharge from the ICU，an average of 1 week4
Physiological outcomes (heart rate)
The patient's heart rate will be recorded at the start of each communication, and the variability of heart rate during communication will be calculated.
Time frame
up to 2 days after enrollmentLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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