Eye Tracking for Early Identification of Post-ICU Cognitive Impairment
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorShanghai Zhongshan Hospital
About this trial
Some patients may have problems with memory, attention, thinking speed, or other cognitive functions after leaving the intensive care unit (ICU). This is called post-ICU cognitive impairment. Early recognition of this problem may help clinicians provide follow-up care and support more promptly.
This study will explore whether eye-tracking technology can help identify cognitive impairment in patients soon after ICU discharge. Eye tracking is a non-invasive test that records eye movements while a person looks at images or completes simple visual tasks on a screen. The test does not involve any treatment or change in usual medical care.
Participants will be adult patients who have been transferred from the ICU to a general ward. Within 7 days after ICU discharge, participants will complete a cognitive assessment and an eye-tracking test. The study team will also collect relevant clinical information from medical records. Patients will be grouped according to whether they have post-ICU cognitive impairment based on cognitive assessment and clinical judgment.
The main purpose of this study is to assess whether information obtained from eye-tracking tests can help clinicians identify possible post-ICU cognitive impairment at an early stage, when used together with standard cognitive assessment. The study will also compare eye movement patterns between the two groups and explore whether eye-tracking measures add useful information beyond standard cognitive assessment.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Successfully transferred from the ICU to a general ward after ICU treatment.
ICU length of stay of at least 24 hours.
Conscious and able to cooperate with cognitive assessment and eye-tracking tests.
Willing to participate in the study and able to provide written informed consent.
Disqualifiers
Diagnosed with cognitive impairment before ICU admission, such as Alzheimer's disease, based on medical history or previous medical records.
Previous diagnosis of mental illness or intellectual developmental disorder.
Severe visual, hearing, or eye disease that prevents completion of cognitive assessment or eye-tracking tasks.
Severe neurological disease that may affect cognitive function, such as stroke, traumatic brain injury, or intracranial infection.
Trial population
The study population will consist of patients who have been successfully transferred from the intensive care unit (ICU) to a general ward after ICU treatment at Zhongshan Hospital, Fudan University. Eligible participants will have stayed in the ICU for at least 24 hours, be conscious, and be able to complete cognitive assessment and eye-tracking tests. Participants will undergo study assessments within 7 days after ICU discharge. No intervention will be assigned by the study.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
73 Participants
are grouped into 2 trial groupsGroup A: Post-ICU Cognitive Impairment Group
Group B: Non-Post-ICU Cognitive Impairment Group
Trial outcomes
Primary outcomes
1
Auxiliary Identification Performance of Eye-Tracking-Derived Parameters for Post-ICU Cognitive Impairment
The area under the receiver operating characteristic curve (AUC) will be used to evaluate how well selected eye-tracking-derived parameters, alone or in combination, support the identification of post-ICU cognitive impairment. Post-ICU cognitive impairment will be determined using DSM-5 neurocognitive disorder criteria together with clinical assessment and education-corrected Montreal Cognitive Assessment (MoCA) score.
Time frame
Within 7 days after ICU dischargeSecondary outcomes
1
Occurrence of Post-ICU Cognitive Impairment
The proportion of enrolled participants classified as having post-ICU cognitive impairment will be summarized. Post-ICU cognitive impairment will be determined using DSM-5 neurocognitive disorder criteria together with clinical assessment and education-corrected MoCA score.
Time frame
Within 7 days after ICU discharge2
Differences in Eye-Tracking-Derived Parameters Between Cognitive Status Groups
Eye-tracking-derived parameters will be compared between participants with and without post-ICU cognitive impairment. Parameters may include saccade latency, saccade accuracy, saccade error rate, mean saccade amplitude, mean saccade velocity, mean saccade duration, fixation time, and uncorrected error rate.
Time frame
Within 7 days after ICU dischargeSponsors and contacts
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Source ClinicalTrials.gov
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