Eye-Tracking Interaction System for Non-verbal ICU Patients

NCT07205419 | Not Yet Recruiting

• 1 other identifier: ZS202500100
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objectives of this clinical trial are to explore the feasibility of the eye-tracking interactive system in improving communication disorders among non-verbal ICU patients. It will also preliminarily investigate the effectiveness of this system in facilitating communication for these patients. Researchers will compare the eye-tracking interactive system with traditional augmentative and alternative communication (AAC) technologies (such as body language, writing boards, etc.) to observe the feasibility and preliminary effectiveness of the eye-tracking interactive system in improving communication disorders. Participants will:

• Use augmentative and alternative communication technologies daily
• Have detailed records of every communication interaction

Conditions

Communication Barriers; Eye-tracking Technology; ICU Patients

Outcome Measures

Primary Outcomes (3)

• Communication efficiency

  Communication efficiency is defined as the number of correctly expressed needs per minute, calculated as the total number of correctly expressed needs divided by the duration in minutes. The aforementioned duration of assistive communication and total number of correctly expressed needs will be documented in the Communication Information Registration Form.

  up to 5 days after enrollment

• Communication accuracy

  Communication accuracy is calculated as the number of correctly expressed needs divided by the total number of expressed needs. The aforementioned total number of expressed needs and total number of correctly expressed needs will be documented in the Communication Information Registration Form.

  up to 5 days after enrollment

• Patients' communication ability

  The LCS (Loewenstein Communication Scale) will be used to assess patients' communication ability. This tool is primarily used in clinical practice to assess the communication abilities of minimally responsive patients. It comprises five hierarchical functions: mobility, respiration, visual responsiveness, auditory comprehension, and communication. Each function is divided into five parameters, with scores ranging from 0 to 4 (each function has a maximum score of 20, and the total score is 100).

  up to 5 days after enrollment

Secondary Outcomes (6)

• Nurses' compliance

  through study completion, an average of 1 year

• Time spent training patients during initial use

  Day 1

• Incidence of delirium

  at 9:00 AM and 9:00 PM daily

• Patient satisfaction

  up to 5 days after enrollment

• Patient enrollment rate

  through study completion, an average of 1 year

Study Arms (2)

Control Group:

NO INTERVENTION

Charge nurses will lead communication through 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 interaction system. An eye-tracking interaction system refers to an eye-tracking interaction interface installed on any electronic device equipped with a camera that meets the configuration requirements.

Device: Eye-Tracking Interaction System

Interventions

Eye-Tracking Interaction System DEVICE

The eye-tracking interactive interface designed based on evidence-based and co-design principles is installed on tablets or computers equipped with cameras, forming the eye-tracking interactive system.

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
• 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;④Primary caregivers are adults
• Able to read Chinese characters and follow simple commands
• Willing to participate in this study

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• 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: April 1, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: October 3, 2025

Record last verified: 2025-09