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NCT Number: NCT07429695

Eye-Tracking Interactive Agent in Non-verbal ICU Patients

The goal of this clinical trial is to determine whether an eye-tracking interactive agent can ameliorate communication impairments and reduce the incidence of complications among non-verbal patients in the intensive care unit (ICU). The main questions it aims to answer are:

Does the eye tracking interactive agent alleviate communication impairments among non-verbal patients in the ICU? Does the eye tracking interactive agent improve communication efficiency among non-verbal patients in the ICU? Does the eye tracking interactive agent m reduce the incidence of negative emotions among non-verbal patients in the ICU? Does the eye tracking interactive agent shorten the ICU length of stay for non-verbal patients in the ICU? Does the eye tracking interactive agent reduce the dosage of analgesic and sedative medications for non-verbal patients in the ICU? Does the eye tracking interactive agent improve family satisfaction for non-verbal patients in the ICU? Does the eye tracking interactive agent alleviate nurses' communication burden among non-verbal patients in the ICU? Researchers will compare eye tracking interactive agent to conventional techniques to see if e eye tracking interactive agent works to alleviate communication impairments.

Participants will:

Use an eye tracking interactive agent for augmentative communication for 2 consecutive days Document each communication's details, ICU LOS, and analgesic-sedative dosages; assess communication difficulty severity, delirium, anxiety, family satisfaction and nurses' communication burden with validated scales.

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Key information

Conditions

Eye Tracking Behavior Communication Communication Barriers ICU Non-Verbal Communication Nonverbal Communication

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
  • 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
  • Primary 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.

Treatment and study plan

eye-tracking interactive agent

Device

The eye-tracking interactive agent consists of an eye-tracker, an iPad, and a floor-standing stand. Positioned at the patient's bedside, the system is activated upon the patient's eye opening, allowing the patient to vocalize via this eye-tracking interactive system.

conventional techniques

Other

Nurses communicate with patients through verbal inquiry, hand gestures, head nods or shakes, and simple paper-and-pencil tools; patients unable to write communicate solely via body language. Needs are guessed only when patients exhibit obvious discomfort.

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. Communication efficiency

    Time frame: up to 2 days after enrollment

    the number of successful communications within 24 hours

  2. Anxiety

    Time frame: at 4:00 PM daily

    Anxiety level will be measured using the Faces Anxiety Scale. This is a single-item scale with five response options, ranging from neutral expression (1 point) to extreme anxiety (5 points).

  3. Delirium-free days

    Time frame: through discharge from the ICU，an average of 1 week

    Delirium-free days refer to the total number of complete calendar days without delirium during the ICU stay.

  4. Physiological outcomes (heart rate)

    Time frame: up to 2 days after enrollment

    The patient's heart rate will be recorded at the start of each communication, and the variability of heart rate during communication will be calculated.

  5. Physiological outcomes (blood pressure)

    Time frame: up to 2 days after enrollment

    The patient's blood pressure will be recorded at the start of each communication, and the variability of blood pressure during communication will be calculated.

  6. Length of ICU stay

    Time frame: through discharge from the ICU，an average of 1 week

    The total length of the patient's ICU stay will be recorded.

  7. Dosage of analgesic and sedative medications

    Time frame: up to 2 days after enrollment

    The daily dosage of analgesic and sedative medications administered to the patient will be recorded.

  8. Satisfaction of primary caregivers

    Time frame: through discharge from the ICU，an average of 1 week

    Family satisfaction will be assessed using the Family Satisfaction in the ICU-24 (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.

  9. Communication burden of medical staffs

    Time frame: through study completion，an average of 1 year

    The communication burden of ICU nurses was assessed using the NASA Task Load Index (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.

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Registry information

Official study title

Eye-Tracking Interactive Agent in Non-verbal ICU Patients: A Study Protocol of a Randomized Controlled Trial With an Embedded Qualitative Study

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 24, 2026
Registry last updated
Feb 24, 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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