Hospital Clínico de la Universidad de Chile
Santiago, Santiago Metropolitan, 8320000, Chile
NCT Number: NCT07806487
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.
Interested in participating?
Request Info70 year and older
All sexes
Observational
Santiago, Santiago Metropolitan, 8320000, Chile
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:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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)
Time frame: 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).
Time frame: Up to 30 days post-surgery.
Total hospital stay from the day of surgery until official hospital discharge.
Time frame: At 30 days post-surgery.
Total number of participant deaths from any cause, verified via hospital electronic medical records or direct follow-up contact.
University of Chile
Other
Predicting Post-operative Delirium Using Eye Movements: a Pilot Study
Acronym: EYE-POD
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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