An observational study in Post Operative Delerium and Post Operative Cognitive Dysfunction, sponsored by University of Chile. Enrolling by invitation at 1 site in Chile. Open to participants aged 70 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-08.
Sponsored by University of Chile · Observational
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.
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:
752 studies on the registry are indexed under Emergence Delirium; 262 are open to participants now.
This study's planned enrollment of 40 is below the median of 164 across 278 observational studies indexed under Emergence Delirium.
Browse Emergence Delirium studies →University of Chile is the lead sponsor of 194 studies on the registry; 38 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Incidence of postoperative delirium (POD).
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.
Time frame: From the day of surgery up to postoperative day 3, patients were assessed twice daily.
Preoperative Baseline Cognitive Status
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.
Time frame: At preoperative baseline (day of surgery or day before).
Preoperative Comorbidity Burden
Score on the Charlson Comorbidity Index (CCI) to quantify the participant's baseline medical comorbidity burden and pre-existing health conditions.
Time frame: At preoperative baseline (day of surgery or day before)
Preoperative Saccadic Latency
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).
Time frame: At preoperative baseline (day of surgery or day before)
Preoperative Saccadic Velocity
The peak speed of the participant's eye movement when moving towards the visual target during the prosaccadic task (degrees per second).
Time frame: At preoperative baseline (day of surgery or day before).
Preoperative Free Viewing Number of Fixations
The absolute count of discrete gaze fixations made by the participant during the free visual exploration task (number of fixations)
Time frame: At preoperative baseline (day of surgery or day before).
Preoperative Free Viewing Saccade Length
The average spatial distance between fixations in the participant's eye movements during the free visual exploration task (degrees of visual angle).
Time frame: At preoperative baseline (day of surgery or day before).
Hospital Length of Stay
Total hospital stay from the day of surgery until official hospital discharge.
Time frame: Up to 30 days post-surgery.
All-Cause Mortality
Total number of participant deaths from any cause, verified via hospital electronic medical records or direct follow-up contact.
Time frame: At 30 days post-surgery.
Plan to share: Undecided
Started Aug 2026 (actual). Primary completion is estimated for Dec 2026, 4 months after the start.
Of 180 non-industry observational studies under Emergence Delirium, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's planned 4 months is below that.
Counting every sponsor, half of 180 studies reached it within 21 months; a quarter within 10 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
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