Eye-Tracking Interaction System for Non-verbal ICU Patients

Fudan University

Status: Begins enrollment in 1 month

Conditions: ICU Patients; Eye-tracking Technology; Communication Barriers

Treatments: Device: Eye-Tracking Interaction System

Study type: Interventional

Funder types: Other

Identifiers

NCT07205419

ZS202500100

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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;④Primary 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Control Group:

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Device: Eye-Tracking Interaction System