Electroencephalographic Biomarker to Predict Postoperative Delirium

NCT05992506 | Active Not Recruiting

• 1 other identifier: IT21I0041
• Study Type: observational
• Target: 264
• Locations: 1 country
• Sites: 2

Brief Summary

Acute post-operatory cognitive dysfunction states are one of the most important complications in older patients that underwent surgery. Among them postoperative delirium (POD) is the the most studied. Patients who develop delirium have poorer long-term outcomes, such as longer length of hospital stay, institutionalization at discharge, and even higher mortality, and consequently, the human and economic costs significantly increase for the health system. Here the research team will use an observational cohort, investigator blinded in five-center with a primary endpoint to validate intraoperative EEG analysis as a reliable biomarker of postoperative delirium.

Conditions

Postoperative Delirium

Keywords

EEG; Postoperative Delirium; Risk Assessment; Anesthesia

Outcome Measures

Primary Outcomes (1)

• Postoperative Delirium

  Incidence of POD in the cohort diagnosed using the Confusion Assessment Method (CAM) twice/day

  First 3 days after surgery

Secondary Outcomes (6)

• Death

  30 days after surgery

• Delirium Severity

  First 3 days after surgery

• Delirium Duration

  First 3 days after surgery

• Need for Mechanical Ventilation

  First 3 days after surgery

• Reintervention

  First 3 days after surgery

Study Arms (1)

Patients at risk of developing POD

* Patients older than 60 years * Scheduled for elective surgery of moderate or high risk (defined as that which requires a subsequent hospitalization of at least 3 days) under general anesthesia. * Signed informed consent.

Diagnostic Test: POD risk estimation using PEUMA

Interventions

POD risk estimation using PEUMA DIAGNOSTIC_TEST

A software will analyze intraoperative EEG recording for the estimation of a POD Risk Index

Patients at risk of developing POD

Eligibility Criteria

• Age: 60 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients at risk of developing POD will be evaluated in the pre and postoperative period for cognitive dysfunction and the appearance of POD. In the intraoperative period, an EEG-based monitorization will be performed using a SedLine (Masimo, CA) Monitor.

You may qualify if:

• Age ≥ 60 years old
• Scheduled for high-risk elective surgery
• Need for at least 3 days of hospital stay after surgery
• Surgery performed under general anesthesia
• Written informed consent for participation in the trial

You may not qualify if:

• Patients with preoperative delirium or dementia
• Patients using neuroleptics drug during the past 6 months
• Patients with a history of encephalopathy, psychosis, stroke or brain trauma with neurologic sequels
• The use of ketamine or dexmedetomidine during surgery
• Emergency surgery
• Mechanical ventilation during the 72 after surgery
• Analphabetism
• Patients who do not talk Spanish
• Patients included in another clinical trial

Sponsors & Collaborators

• University of Chile: lead
• Instituto Nacional del Cancer, Chile: collaborator
• Pontificia Universidad Catolica de Chile: collaborator
• Hospital Base San Jose Osorno: collaborator
• Clinica Santa Maria: collaborator

Study Sites (2)

Hospital Clinico Universidad de Chile

Santiago, Santiago Metropolitan, 8380456, Chile

Location

Instituto Nacional del Cancer

Santiago, Santiago Metropolitan, Chile

Location

Related Publications (3)

• Riley RD, Ensor J, Snell KIE, Harrell FE Jr, Martin GP, Reitsma JB, Moons KGM, Collins G, van Smeden M. Calculating the sample size required for developing a clinical prediction model. BMJ. 2020 Mar 18;368:m441. doi: 10.1136/bmj.m441. No abstract available.

  PMID: 32188600 RESULT

• Gutierrez R, Egana JI, Saez I, Reyes F, Briceno C, Venegas M, Lavado I, Penna A. Intraoperative Low Alpha Power in the Electroencephalogram Is Associated With Postoperative Subsyndromal Delirium. Front Syst Neurosci. 2019 Oct 18;13:56. doi: 10.3389/fnsys.2019.00056. eCollection 2019.

  PMID: 31680886 RESULT

• Wong CK, van Munster BC, Hatseras A, Huis In 't Veld E, van Leeuwen BL, de Rooij SE, Pleijhuis RG. Head-to-head comparison of 14 prediction models for postoperative delirium in elderly non-ICU patients: an external validation study. BMJ Open. 2022 Apr 8;12(4):e054023. doi: 10.1136/bmjopen-2021-054023.

  PMID: 35396283 RESULT

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2023
• First Posted: August 15, 2023
• Study Start: September 1, 2023
• Primary Completion: October 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: November 20, 2025

Record last verified: 2025-10

Locations

CL (2)