Post Operative DeleriumEYE-PODNCT07806487
Eye Movements to Predict Post-Operative Delirium
An observational study of Post Operative Delerium and Post Operative Cognitive Dysfunction, run by University of Chile at 1 site in Chile.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Post Operative Delerium, Post Operative Cognitive Dysfunction
- How many people
- 40 participants
- Where
- 1 siteChile
- Study dates
- 6 Aug 2026to Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 10Show fewer
- Visual acuity is insufficient to complete the automated eye-tracking tasks.
- Illiteracy.
- Non-Spanish speakers.
- Concurrent participation in any other clinical trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chile1 site
Hospital Clínico de la Universidad de Chile
Santiago, Santiago Metropolitan, 8320000
About this study
Official title: 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.
Read the detailed description
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.
- Keywords
- Post operative delirium, Eye movements, Eye-tracking
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From the day of surgery up to postoperative day 3, patients were assessed twice daily.
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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)
Measured: 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).
Measured: 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.
Measured: 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.
Measured: At 30 days post-surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start6 Aug 2026
- Primary completionDec 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Post Operative DeleriumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Iván Plaza-Rosales, University of Chile
- Investigators
- Ivan Plaza-Rosales, PhD, Principal investigator, University of Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07806487
- Sponsor's protocol ID
- 159526
- Acronym
- EYE-POD
- Status last verified
- Jul 2026
- First submitted
- 3 Aug 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 24495403Chapin 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.
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.
PubMed 39050621
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Post-operative Delirium Using Eye Movements: a Pilot Study
- ClinicalTrials.gov ID
- NCT07806487
- Acronym / sponsor ID
- EYE-POD / 159526
- Keywords
- Post operative delirium, Eye movements, Eye-tracking
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Study start
- 6 Aug 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 8 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of postoperative delirium (POD).
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.
8 secondary outcomes
Preoperative Baseline Cognitive Status
Time frame: At preoperative baseline (day of surgery or day before).
Preoperative Comorbidity Burden
Time frame: At preoperative baseline (day of surgery or day before)
Preoperative Saccadic Latency
Time frame: At preoperative baseline (day of surgery or day before)
Preoperative Saccadic Velocity
Time frame: At preoperative baseline (day of surgery or day before).
Preoperative Free Viewing Number of Fixations
Time frame: At preoperative baseline (day of surgery or day before).
Preoperative Free Viewing Saccade Length
Time frame: At preoperative baseline (day of surgery or day before).
Hospital Length of Stay
Time frame: Up to 30 days post-surgery.
All-Cause Mortality
Time frame: At 30 days post-surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Background: PubMed 24495403van 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.
- BackgroundChapin 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.
- Background: PubMed 39050621Al-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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ivan Plaza-Rosales, PhD principal investigator
University of Chile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post Operative Delerium and Post Operative Cognitive Dysfunction, run by University of Chile at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative delirium (POD). (time frame: From the day of surgery up to postoperative day 3, patients were assessed twice daily.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07806487, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.