Eye-Tracking Communication Tool for Non-verbal ICU Patients

NCT07205419 | Not Yet Recruiting

• 1 other identifier: ZS202500100
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Communication Barriers; Eye-tracking Technology; ICU Patients

Outcome Measures

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.

  up to 2days after enrollment

Secondary Outcomes (7)

• Well-being and safety

  at 4:00 PM daily

• Satisfaction of family members

  up to 2 days after enrollment

• Communication burden of ICU healthcare professionals

  up to 2 days after enrollment

• Nurses' compliance

  through study completion，an average of 2 year

• Time spent training patients during initial use

  Day 1

Study Arms (2)

Control Group:conventional techniques group

NO INTERVENTION

Charge nurses will lead communication through conventional methods, including body language (e.g., pointing, nodding, shaking the head) or by providing writing boards for patients to write. Patients unable to write will communicate solely through body language.

Intervention Group

EXPERIMENTAL

Charge nurses will lead communication using the eye-tracking communication tool.

Device: Eye-Tracking communication tool

Interventions

Eye-Tracking communication tool DEVICE

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.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• blindness or inability to elevate the eyelids that preclude successful participation in eye-tracking interaction tasks
• cognitive impairment limiting meaningful participation
• severe psychological distress

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2025
• First Posted: October 3, 2025
• Study Start: July 1, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: May 27, 2026

Record last verified: 2026-05