NCT07429695

Eye-Tracking Interactive Agent in Non-verbal ICU Patients

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Eye Tracking
• ICU
• Communication Barriers
• Non-Verbal Communication

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2026-02-24
• Last updated: 2026-02-24