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NCT Number: NCT07205419

Eye-Tracking Communication Tool for Non-verbal ICU Patients

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  1. Communication difficulty

    Time frame: up to 2days after enrollment

    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.

Secondary outcomes

  1. Well-being and safety

    Time frame: at 4:00 PM daily

    The degree of well-being and safety in non-verbal ICU patients will be assessed using the practical co-constructed intensive care patients' well-being and safety scale (TOURS Scale). This scale consists of 4 items, with response options ranging from 0 (not at all) to 3 (very). The total score ranges from 0 to 12, with higher scores indicating better well-being and safety.

  2. Satisfaction of family members

    Time frame: up to 2 days after enrollment

    Family satisfaction will be assessed using the FS-ICU-24 scale. This scale consists of 24 items and has been well validated for measuring satisfaction among family members of patients admitted to the ICU. The scale comprises two domains: satisfaction with care and satisfaction with decision-making. Each item is scored on a continuous scale ranging from 0 to 100. The domain score is calculated as the sum of all valid item scores within that domain divided by the number of valid items in the respective domain. The total FS-ICU-24 score is computed as the sum of the two domain mean scores divided by 2, with higher scores representing a higher level of satisfaction.

  3. Communication burden of ICU healthcare professionals

    Time frame: up to 2 days after enrollment

    The communication burden of ICU healthcare professionals will be assessed using the NASA-TLX. This scale has been widely used to evaluate the subjective workload of healthcare providers and covers six domains: mental demand, physical demand, temporal demand, performance level, effort, and frustration. Each of the six domains is scored on a continuous scale ranging from 0 to 100, where a score of 0 indicates the lowest level of the domain and a score of 100 indicates the highest level.

  4. Nurses' compliance

    Time frame: through study completion,an average of 2 year

    Nurses' intervention behaviors will be documented during unscheduled supervision.The compliance of nurses will be defined as the number of communication sessions conducted by nurses with intervention group patients via the communication tool divided by the total number of communication sessions.

  5. Time spent training patients during initial use

    Time frame: 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.

  6. Patient enrollment rate

    Time frame: through study completion, an average of 2 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.

  7. Patient withdrawal rate

    Time frame: through study completion, an average of 2 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.

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Registry information

Official study title

Co-design and Pilot Feasibility Evaluation of an Eye-tracking Communication Tool for Conscious Non-verbal ICU Patients: Study Protocol for a Feasibility Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Oct 3, 2025
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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