Eye-Tracking Communication Tool for Non-verbal ICU Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Eye-Tracking communication tool.
- Who it may be relevant to
- Registry conditions: Communication Barriers, Eye-tracking Technology, ICU Patients. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Co-design and Pilot Feasibility Evaluation of an Eye-tracking Communication Tool for Conscious Non-verbal ICU Patients: Study Protocol for a Feasibility Randomized Controlled Trial
Overview
The objectives of this clinical trial are to explore the feasibility of the eye-tracking communication tool in alleviating communication barriers among non-verbal ICU patients. It will also preliminarily investigate the effectiveness of this tool in facilitating communication for these patients. Researchers will compare the eye-tracking communication tool with conventional techniques (such as body language, writing boards, etc.) to observe the feasibility and preliminary effectiveness of the eye-tracking communication tool in alleviating communication barriers. Participants will use an eye-tracking communication tool for augmentative communication for 2 consecutive days.
Interventions
- Device Eye-Tracking communication tool
The eye-tracking interactive interface designed based on evidence-based and co-design.The eye-tracking communication tool consists of an eye-tracker, a tablet, and a floor-standing stand. The tool will be placed at the patient's bedside 24 hours a day to facilitate real-time communication.
Primary outcome measures
- Communication difficulty [Time frame: up to 2days after enrollment]
Secondary outcome measures (7)
- Well-being and safety [Time frame: at 4:00 PM daily]
- Satisfaction of family members [Time frame: up to 2 days after enrollment]
- Communication burden of ICU healthcare professionals [Time frame: up to 2 days after enrollment]
- Nurses' compliance [Time frame: through study completion，an average of 2 year]
- Time spent training patients during initial use [Time frame: Day 1]
- Patient enrollment rate [Time frame: through study completion, an average of 2 year]
- Patient withdrawal rate [Time frame: through study completion, an average of 2 year]
Eligibility criteria
Inclusion criteria
- aged ≥ 18 years
- ICU stay ≥ 24 hours
- 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 ranging from -1 to 1
- able to comply with simple instructions for study participation
Exclusion criteria
- blindness or inability to elevate the eyelids that preclude successful participation in eye-tracking interaction tasks
- cognitive impairment limiting meaningful participation
- severe psychological distress
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07205419 · ZS202500100