[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100625981":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":11,"locations":11,"responsibleParty":29,"collaborators":11,"id":33,"slug":11,"hasResults":34,"nctId":35,"briefTitle":36,"officialTitle":37,"acronym":11,"eligibilityCriteria":38,"healthyVolunteers":34,"sex":39,"minAge":40,"maxAge":11,"enrollmentInfo":41,"targetDuration":11,"studyType":44,"phases":45,"briefSummary":47,"conditions":48,"keywords":11,"overallStatus":53,"whyStopped":11,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":11},{"fullName":5,"class":6},"Shanghai Zhongshan Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"eye-tracking group","EXPERIMENTAL",null,[13],"Device: eye-tracking interactive agent",{"label":15,"type":16,"description":11,"interventionNames":17},"conventional techniques group","PLACEBO_COMPARATOR",[18],"Other: conventional techniques",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"DEVICE","eye-tracking interactive agent","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.",[9],{"type":6,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"conventional techniques","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.",[15],{"type":30,"investigatorFullName":31,"investigatorTitle":32,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Shining Cai","charge nurse","100625981",false,"NCT07429695","Eye-Tracking Interactive Agent in Non-verbal ICU Patients","Eye-Tracking Interactive Agent in Non-verbal ICU Patients: A Study Protocol of a Randomized Controlled Trial With an Embedded Qualitative Study","Inclusion Criteria:\n\n* Aged ≥ 18 years\n* Patients in the ICU who are unable to communicate through normal verbal means due to endotracheal intubation\u002Ftracheotomy, muscle or nerve injury, acute\u002Fchronic spinal cord injury, etc.\n* Richmond Agitation-Sedation Scale (RASS) score of -1 to 1\n* Primary caregivers are adults\n* Able to read Chinese characters and follow simple commands\n* Willing to participate in this study.\n\nExclusion Criteria:\n\n* Diseases associated with cognitive impairment, such as pulmonary encephalopathy, hepatic encephalopathy, diabetic hyperosmolar coma, and coma of unknown cause\n* A history of mental disorders, dementia or pre-dementia, or intellectual disability\n* Conditions precluding cooperation with eye-tracking interaction, such as blindness or inability to elevate the eyelids.","ALL","18 Years",{"count":42,"type":43},54,"ESTIMATED","INTERVENTIONAL",[46],"NA","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:\n\nDoes 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.\n\nParticipants will:\n\nUse 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.",[49,50,51,52],"Eye Tracking","ICU","Communication Barriers","Non-Verbal Communication","NOT_YET_RECRUITING","2026-02-22",{"date":56,"type":57},"2026-02-24","ACTUAL",{"date":59,"type":43},"2026-04-01",{"date":61,"type":43},"2027-12-31",{"name":5,"class":6}]