Клинические исследование Послеоперационный Делериум, Послеоперационная когнитивная дисфункция - Реестр клинических исследований

Обзор исследования

Статус

Запись по приглашению

Условия

Подробное описание

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:

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.
Diagnostic Performance: To calculate the sensitivity and specificity of these distinct preoperative eye movement parameters for predicting POD development.
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.

Тип исследования

Наблюдательный

Регистрация (Оцененный)

40

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

Чили
- Santiago Metropolitan
  - Santiago, Santiago Metropolitan, Чили, 8320000
    - Hospital Clínico de la Universidad de Chile

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

Пожилой взрослый

Принимает здоровых добровольцев

Да

Метод выборки

Невероятностная выборка

Исследуемая популяция

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.

Описание

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.

Учебный план

В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

Количество групп / когорт

1

Когорты и вмешательства

Группа / когорта
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.

Группа / когорта

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.

Что измеряет исследование?

Первичные показатели результатов

Мера результата	Мера Описание	Временное ограничение
Incidence of postoperative delirium (POD). Временное ограничение: 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.

Вторичные показатели результатов

Мера результата	Мера Описание	Временное ограничение
Preoperative Baseline Cognitive Status Временное ограничение: 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 Временное ограничение: 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 Временное ограничение: 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 Временное ограничение: 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 Временное ограничение: 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 Временное ограничение: 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 Временное ограничение: 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 Временное ограничение: 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.

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

University of Chile

Следователи

Главный следователь: Ivan Plaza-Rosales, PhD, University of Chile

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

Общие публикации

Al-Hindawi A, Vizcaychipi M, Demiris Y. A Dual-Camera Eye-Tracking Platform for Rapid Real-Time Diagnosis of Acute Delirium: A Pilot Study. IEEE J Transl Eng Health Med. 2024 May 7;12:488-498. doi: 10.1109/JTEHM.2024.3397737. eCollection 2024.
van der Kooi AW, Rots ML, Huiskamp G, Klijn FA, Koek HL, Kluin J, Leijten FS, Slooter AJ. Delirium detection based on monitoring of blinks and eye movements. Am J Geriatr Psychiatry. 2014 Dec;22(12):1575-82. doi: 10.1016/j.jagp.2014.01.001. Epub 2014 Jan 4.
Chapin BA, Kimmett F, Garvan C, Tighe P, Dekosky S, Williamson JB, Price CC. Preoperative Visual Attention Performance Predicts Postoperative Delirium. Alzheimers Dement. 2025 Jan 3;20(Suppl 3):e091620. doi: 10.1002/alz.091620. PMCID: PMC11710506.

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

6 августа 2026 г.

Первичное завершение (Оцененный)

1 декабря 2026 г.

Завершение исследования (Оцененный)

1 марта 2027 г.

Даты регистрации исследования

Первый отправленный

3 августа 2026 г.

Впервые представлено, что соответствует критериям контроля качества

1 сентября 2026 г.

Первый опубликованный (Действительный)

8 сентября 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)