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Eye Movements to Predict Post-Operative Delirium (EYE-POD)

2026年9月1日 更新者:Iván Plaza-Rosales、University of Chile

Predicting Post-operative Delirium Using Eye Movements: a Pilot Study

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.

研究概览

地位

邀请报名

详细说明

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.

All eye-tracking data will be recorded using automated software to ensure objectivity and reproducibility.

Postoperative Monitoring Following the surgical procedure, patients will be systematically monitored for the development of POD. The Confusion Assessment Method (CAM) will be administered by trained examiners twice daily (morning and evening) for the first three postoperative days (72 hours) to detect and document the incidence and severity of delirium.

Statistical and Predictive Objectives

The collected data will be analyzed to fulfill three primary scientific objectives:

  1. Parameter Association: To identify which specific preoperative eye-tracking metrics (latency, velocity, accuracy, or free-gaze variables) demonstrate a statistically significant association with the incidence of POD.
  2. Diagnostic Performance: To calculate the sensitivity and specificity of these distinct preoperative eye movement parameters for predicting POD development.
  3. Incremental Predictive Value: To evaluate whether adding preoperative eye-tracking measurements to a standard clinical prediction model (comprising age, sex, CCI, and MoCA scores) significantly improves the model's overall predictive performance and risk stratification capabilities.

研究类型

观察性的

注册 (估计的)

40

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Santiago Metropolitan
      • Santiago、Santiago Metropolitan、智利、8320000
        • Hospital Clínico de la Universidad de Chile

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 年长者

接受健康志愿者

是的

取样方法

非概率样本

研究人群

Older adult patients scheduled for moderate- to high-risk surgeries at the Hospital Clínico de la Universidad de Chile. The cohort is drawn from the elective surgical scheduling pool of the institution, aiming for a balanced distribution across biological sex and age ranges within the target demographic.

描述

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Incidence of postoperative delirium (POD).
大体时间: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.
From the day of surgery up to postoperative day 3, patients were assessed twice daily.

次要结果测量

结果测量
措施说明
大体时间
Preoperative Baseline Cognitive Status
大体时间:At preoperative baseline (day of surgery or day before).
Total score on the Montreal Cognitive Assessment (MoCA) to determine baseline global cognitive function. The score ranges from 0 to 30, with lower scores indicating greater cognitive impairment.
At preoperative baseline (day of surgery or day before).
Preoperative Comorbidity Burden
大体时间:At preoperative baseline (day of surgery or day before)
Score on the Charlson Comorbidity Index (CCI) to quantify the participant's baseline medical comorbidity burden and pre-existing health conditions.
At preoperative baseline (day of surgery or day before)
Preoperative Saccadic Latency
大体时间:At preoperative baseline (day of surgery or day before)
The time taken from the appearance of a visual target to the initiation of the participant's saccadic eye movement during the prosaccadic task (milliseconds).
At preoperative baseline (day of surgery or day before)
Preoperative Saccadic Velocity
大体时间:At preoperative baseline (day of surgery or day before).
The peak speed of the participant's eye movement when moving towards the visual target during the prosaccadic task (degrees per second).
At preoperative baseline (day of surgery or day before).
Preoperative Free Viewing Number of Fixations
大体时间:At preoperative baseline (day of surgery or day before).
The absolute count of discrete gaze fixations made by the participant during the free visual exploration task (number of fixations)
At preoperative baseline (day of surgery or day before).
Preoperative Free Viewing Saccade Length
大体时间:At preoperative baseline (day of surgery or day before).
The average spatial distance between fixations in the participant's eye movements during the free visual exploration task (degrees of visual angle).
At preoperative baseline (day of surgery or day before).
Hospital Length of Stay
大体时间:Up to 30 days post-surgery.
Total hospital stay from the day of surgery until official hospital discharge.
Up to 30 days post-surgery.
All-Cause Mortality
大体时间:At 30 days post-surgery.
Total number of participant deaths from any cause, verified via hospital electronic medical records or direct follow-up contact.
At 30 days post-surgery.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Ivan Plaza-Rosales, PhD、University of Chile

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年8月6日

初级完成 (估计的)

2026年12月1日

研究完成 (估计的)

2027年3月1日

研究注册日期

首次提交

2026年8月3日

首先提交符合 QC 标准的

2026年9月1日

首次发布 (实际的)

2026年9月8日

研究记录更新

最后更新发布 (实际的)

2026年9月8日

上次提交的符合 QC 标准的更新

2026年9月1日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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