Eye Tracking for Early Identification of Post-ICU Cognitive Impairment

Early Identification of Post-ICU Cognitive Impairment Using Eye-Tracking Technology: A Prospective Observational Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cognitive Impairment; Post Intensive Care Syndrome (PICS)

Detailed Description

Post-intensive care syndrome-cognitive impairment (PICS-CI) is a common problem among patients after discharge from the intensive care unit (ICU). It may involve difficulties with memory, attention, executive function, information processing speed, visuospatial ability, or language. These problems may affect long-term recovery, quality of life, treatment adherence, and social participation. Early identification of possible cognitive impairment after ICU discharge is therefore important for follow-up care and rehabilitation planning.

Current assessment of post-ICU cognitive impairment mainly relies on cognitive screening scales and clinical judgment. Although these methods are widely used, they may be influenced by a patient's level of cooperation, education, emotional state, fatigue, and subjective responses. Eye-tracking technology provides objective and quantitative information about eye movement behavior during visual and cognitive tasks. Because eye movements are closely related to attention, inhibitory control, visual processing, and other cognitive processes, eye-tracking-derived parameters may provide additional information to support early cognitive screening after ICU discharge.

This is a prospective, single-center, observational study conducted at Zhongshan Hospital, Fudan University. The study will enroll patients who have been transferred from the ICU to a general ward after ICU treatment. No treatment, medication, device intervention, or change in usual clinical care will be assigned by the study. All study procedures will be performed on the basis of routine care and are intended for research assessment only.

Within 7 days after ICU discharge, participants will complete a standardized cognitive assessment and an eye-tracking test. Cognitive status will be assessed using the Montreal Cognitive Assessment (MoCA), with education-based score correction, together with clinical judgment under the DSM-5 framework for neurocognitive disorders. Based on this assessment, participants will be classified as having post-ICU cognitive impairment or not having post-ICU cognitive impairment.

During the eye-tracking test, participants will complete predefined visual cognitive tasks in a standardized testing environment. Eye movement data will be recorded using eye-tracking equipment and processed using Tobii Pro Lab software according to predefined areas of interest, time windows, and saccade identification rules. Eye-tracking-derived 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. These parameters will be used to describe eye movement behavior related to response initiation, attention orientation, inhibitory control, spatial localization, eye movement execution, and visual processing.

The study team will also collect demographic and clinical information from medical records, including age, sex, education level, ICU-related clinical characteristics, disease severity, ICU length of stay, mechanical ventilation, sedative and analgesic exposure, and other clinically relevant factors. These data will be used to describe the study population and to adjust for potential confounding factors in the analysis.

The main objective of this study is to evaluate whether eye-tracking-derived parameters, alone or in combination, can support the early identification of post-ICU cognitive impairment as an auxiliary tool to standard cognitive assessment. The study will compare eye movement characteristics between patients with and without post-ICU cognitive impairment and examine the association between eye-tracking-derived parameters and cognitive status. The diagnostic performance of selected eye-tracking parameters or parameter combinations will be evaluated using receiver operating characteristic curve analysis. Exploratory models may also assess whether adding eye-tracking-derived parameters to clinical and cognitive assessment information improves identification performance.

Eye tracking is non-invasive and does not involve radiation, medication, or invasive procedures. Some participants may experience temporary eye fatigue, visual discomfort, dizziness, nausea, or other mild discomfort while looking at the screen or completing the visual tasks. The research team will monitor participants during testing and may pause or stop the test if needed. All collected data will be de-identified and managed according to the study data management plan to protect participant privacy and data security.

• Study Type: Observational
• Enrollment (Estimated): 73

Contacts and Locations

• Study Contact: Name: Ai rong Zhu, Bachelor's Degree; Phone Number: +86 15160007359; Email: 2471015405@qq.com

Study Locations

• China
  • Shanghai, China
    • Zhongshan hospital, Fudan university
    • Contact: Yuxia Zhang, PhD; Phone Number: +86 13816881925; Email: zhang.yuxia@zs-hospital.sh.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study 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.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.
• Unable to understand or complete the cognitive assessment or eye-tracking tasks due to severe fatigue, marked inattention, communication disorder, or other reasons as assessed by the research staff.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Post-ICU Cognitive Impairment Group; Participants diagnosed with post-ICU cognitive impairment based on DSM-5 criteria, clinical assessment, and corrected MoCA score.
Non-Post-ICU Cognitive Impairment Group; Participants without post-ICU cognitive impairment based on DSM-5 criteria, clinical assessment, and corrected MoCA score.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Within 7 days after ICU discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Within 7 days after ICU discharge
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.	Within 7 days after ICU discharge

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: June 24, 2026
• First Submitted That Met QC Criteria: June 24, 2026
• First Posted (Actual): June 30, 2026

Study Record Updates

• Last Update Posted (Actual): June 30, 2026
• Last Update Submitted That Met QC Criteria: June 24, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Cognitive Impairment; Intensive Care Unit; Eye Tracking; Cognitive Assessment; Post intensive Care Syndrome
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction; postintensive care syndrome
• Other Study ID Numbers: B2026-360

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No