Eye-Tracking Interaction System for Non-verbal ICU Patients
- Conditions
- Communication BarriersEye-tracking TechnologyICU Patients
- Registration Number
- NCT07205419
- Lead Sponsor
- Shanghai Zhongshan Hospital
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 60
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Communication efficiency up to 5 days after enrollment 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.
Communication accuracy up to 5 days after enrollment 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.
Patients' communication ability up to 5 days after enrollment 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).
- Secondary Outcome Measures
Name Time Method Nurses' compliance through study completion, an average of 1 year The compliance of nurses is defined as the number of times nurses in the intervention group use the eye-tracking interactive system for assistive communication divided by the total number of communication interactions.
Time spent training patients during initial use Day 1 The research team is going to independently develop a Communication Information Registration Form, which is to include the duration of training provided by nurses to patients when they use the eye-tracking interactive system for the first time. After the completion of the intervention, the average training duration is to be calculated.
Incidence of delirium at 9:00 AM and 9:00 PM daily The CAM-ICU (Confusion Assessment Method for the Intensive Care Unit) will be used to assess the occurrence of delirium.The CAM-ICU uses the CAM algorithm and has four features: (1) altered mental status/fluctuating course, (2) inattention, (3) altered level of consciousness, and (4) disorganized thinking. Like the CAM, a patient must be inattentive (cardinal feature of delirium) in order to be CAM-ICU positive.
Patient satisfaction up to 5 days after enrollment The PIADS (Psychosocial Impact of Assistive Devices Scale) will be used to measure the impact of assistive devices on patients and their satisfaction levels.This tool is a 26-item, self-report questionnaire designed to assess the effects of an assistive device on functional independence, well-being, and quality of life. Each item is rated on a 7-point Likert scale, ranging from -3 to +3. Higher scores generally indicate that the assistive device has a more positive impact on these aspects; conversely, lower scores suggest a less positive impact, or even potential negative effects.
Patient enrollment rate through study completion, an average of 1 year The patient enrollment rate is calculated as the number of patients who successfully meet the eligibility criteria and are enrolled in the study divided by the total number of patients screened for eligibility during the study period.
Patient withdrawal rate through study completion, an average of 1 year The patient withdrawal rate is defined as the number of enrolled patients who discontinue study participation (for any reason) prior to the completion of the predefined study protocol (e.g., intervention course) divided by the total number of enrolled patients.