Predicting Post-operative Delirium Using Eye Movements: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Incidence of postoperative delirium (POD).
研究概览
简要总结
Postoperative delirium (POD) is a common complication in older adults undergoing surgery, lacking objective and noninvasive diagnostic methods. This trial aims to evaluate the feasibility and prognostic performance of Eye movements (EM) as a risk biomarker for the development of POD in older patients undergoing moderate- to high-risk surgery. The investigators hypothesize that EM tracking will accurately predict POD, potentially optimizing early intervention and patient outcomes.
详细描述
This prospective trial evaluates the integration of automated eye movement assessments as a novel, noninvasive risk biomarker for postoperative delirium (POD) in older adults. Upon enrollment, trained clinical staff will collect baseline demographic data and clinical characteristics. Chronic medical burden will be quantified using the Charlson Comorbidity Index (CCI). To establish baseline cognitive function and control for preexisting cognitive impairment, all participants will undergo the Montreal Cognitive Assessment (MoCA).
Technical Protocol for Eye Movement Recording
Preoperatively, participants will complete an automated eye movement tracking protocol consisting of two distinct paradigms:
Prosaccadic Task: Utilized to measure specific ocular motor parameters, including saccadic latency, velocity, and accuracy.
Free Visual Exploration Task: Utilized to capture free-gaze metrics and spatial distribution patterns.
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
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged 70 years or older.
- •Scheduled for moderate- to high-risk elective surgery, defined as a procedure requiring a postoperative hospital stay of at least 3 days.
- •Able to provide signed, written informed consent.
排除标准
- •Presence of delirium at baseline admission, evaluated via the Confusion Assessment Method (CAM).
- •Use of neuroleptic/antipsychotic medications within the past 6 months.
- •Prior history of dementia (including Alzheimer's disease, vascular dementia, or mild cognitive impairment).
- •History of encephalopathy.
- •Psychiatric disorders presenting with psychosis.
- •Brain injury with neurological sequelae (e.g., prior stroke, traumatic brain injury).
- •Visual acuity is insufficient to complete the automated eye-tracking tasks.
- •Illiteracy.
- •Non-Spanish speakers.
- •Concurrent participation in any other clinical trial.
研究组 & 干预措施
No Intervention: Control (Usual care) + Eye movement recording
This is a prospective, observational cohort study designed to evaluate the prognostic accuracy of a preoperative eye-tracking biomarker protocol for predicting postoperative delirium (POD). All eligible participants are recruited from a cohort of patients already scheduled for moderate- to high-risk elective surgery at the University of Chile Clinical Hospital.
The study procedures (baseline clinical data collection, Charlson Comorbidity Index, MoCA, and automated eye-tracking tasks) are strictly observational and diagnostic. The eye-tracking results are recorded for research purposes only and do not alter standard perioperative care, surgical management, or anesthetic techniques. Patients are subsequently followed into the postoperative period to monitor the incidence of POD via twice-daily Confusion Assessment Method (CAM) evaluations during the first three postoperative days.
结局指标
主要结局
Incidence of postoperative delirium (POD).
时间窗: From the day of surgery up to postoperative day 3, patients were assessed twice daily.
The presence or absence of postoperative delirium will be assessed using the Confusion Assessment Method (CAM). Patients will be classified as "POD" or "No POD" based on the CAM diagnostic algorithm.
次要结局
- Preoperative Baseline Cognitive Status(At preoperative baseline (day of surgery or day before).)
- Preoperative Comorbidity Burden(At preoperative baseline (day of surgery or day before))
- Preoperative Saccadic Latency(At preoperative baseline (day of surgery or day before))
- Preoperative Saccadic Velocity(At preoperative baseline (day of surgery or day before).)
- Preoperative Free Viewing Number of Fixations(At preoperative baseline (day of surgery or day before).)
- Preoperative Free Viewing Saccade Length(At preoperative baseline (day of surgery or day before).)
- Hospital Length of Stay(Up to 30 days post-surgery.)
- All-Cause Mortality(At 30 days post-surgery.)
研究者
Iván Plaza-Rosales
Assistant professor
University of Chile