Early Identification of Post-ICU Cognitive Impairment Using Eye-Tracking Technology: A Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Auxiliary Identification Performance of Eye-Tracking-Derived Parameters for Post-ICU Cognitive Impairment
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Auxiliary Identification Performance of Eye-Tracking-Derived Parameters for Post-ICU Cognitive Impairment
时间窗: Within 7 days after ICU discharge
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.
次要结局
- Occurrence of Post-ICU Cognitive Impairment(Within 7 days after ICU discharge)
- Differences in Eye-Tracking-Derived Parameters Between Cognitive Status Groups(Within 7 days after ICU discharge)