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Not yet recruiting NCT07429695

Eye-Tracking Interactive Agent in Non-verbal ICU Patients

No phase Interventional Eye Tracking ICU Communication Barriers Non-Verbal Communication

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 interactive agent, conventional techniques.
Who it may be relevant to
Registry conditions: Eye Tracking, ICU, Communication Barriers, Non-Verbal Communication. 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

Eye-Tracking Interactive Agent in Non-verbal ICU Patients: A Study Protocol of a Randomized Controlled Trial With an Embedded Qualitative Study

Overview

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.

Interventions

  • Device eye-tracking interactive agent
    The 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.
  • Other conventional techniques
    Nurses 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.

Primary outcome measures

  • Communication difficulty [Time frame: up to 2days after enrollment]
Secondary outcome measures (9)
  • Communication efficiency [Time frame: up to 2 days after enrollment]
  • Anxiety [Time frame: at 4:00 PM daily]
  • Delirium-free days [Time frame: through discharge from the ICU，an average of 1 week]
  • Physiological outcomes (heart rate) [Time frame: up to 2 days after enrollment]
  • Physiological outcomes (blood pressure) [Time frame: up to 2 days after enrollment]
  • Length of ICU stay [Time frame: through discharge from the ICU，an average of 1 week]
  • Dosage of analgesic and sedative medications [Time frame: up to 2 days after enrollment]
  • Satisfaction of primary caregivers [Time frame: through discharge from the ICU，an average of 1 week]
  • Communication burden of medical staffs [Time frame: through study completion，an average of 1 year]

Eligibility criteria

Inclusion criteria

  • 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
  • Able to read Chinese characters and follow simple commands
  • Willing to participate in this study.

Exclusion criteria

  • 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.

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: NCT07429695 · B2026-073

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗