Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

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

1 de septiembre de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Inscripción por invitación

Condiciones

Descripción detallada

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.

Tipo de estudio

De observación

Inscripción (Estimado)

40

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Santiago Metropolitan
      • Santiago, Santiago Metropolitan, Chile, 8320000
        • Hospital Clínico de la Universidad de Chile

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto Mayor

Acepta Voluntarios Saludables

Sí

Método de muestreo

Muestra no probabilística

Población de estudio

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.

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Incidence of postoperative delirium (POD).
Periodo de tiempo: 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.

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Preoperative Baseline Cognitive Status
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Investigador principal: Ivan Plaza-Rosales, PhD, University of Chile

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

6 de agosto de 2026

Finalización primaria (Estimado)

1 de diciembre de 2026

Finalización del estudio (Estimado)

1 de marzo de 2027

Fechas de registro del estudio

Enviado por primera vez

3 de agosto de 2026

Primero enviado que cumplió con los criterios de control de calidad

1 de septiembre de 2026

Publicado por primera vez (Actual)

8 de septiembre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

8 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

1 de septiembre de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 159526

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .