Skip to content

Electroencephalographic Biomarker to Predict Acute Post-operatory Cognitive Dysfunction

Electroencephalographic Biomarker to Predict the Development of Acute Post-operatory Cognitive Dysfunction States: a Protocol of an Observational Study in a Cohort of Patients From Two Centers

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04214496
Enrollment
106
Registered
2020-01-02
Start date
2021-01-04
Completion date
2022-08-04
Last updated
2023-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Dysfunction, Postoperative Delirium

Keywords

Delirium, Postoperative Delirium, Postoperative Subsyndromal Delirium, Biomarker

Brief summary

Acute post-operatory cognitive dysfunction states are one of the most important complications in older patients after surgery. Two acute cognitive dysfunctions have been described: postoperative delirium (PD) and postoperative subsyndromal delirium (PSSD). Patients who develop delirium, both as a complete or incomplete syndrome, have poor 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 two-center with a primary endpoint to validate the relative alpha power ratio as a predictive biomarker of postoperative cognitive dysfunctions.

Detailed description

Acute post-operatory cognitive dysfunction states are one of the most important complications in older patients after surgery. Two acute cognitive dysfunctions have been described: postoperative delirium (PD) and postoperative subsyndromal delirium (PSSD). In previous reports, the incidence of PD in older patients is between 10% to 30%, while PSSD is more frequent 30% to 50%. Patients who develop delirium, both as a complete or incomplete syndrome, 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. An early diagnostic and prevention of delirium are the key points to decrease the poor long-term outcomes and health costs. The diagnosis requires cognitive testing to elucidate functional patients' status before and after surgery. The need for a biomarker that may predict the occurrence of PD and PSSD and allow the selection of patients who need prevention strategies is a primary research field. Here the research team will use an observational cohort, investigator blinded in two-center with a primary endpoint to validate the relative alpha power ratio as a predictive biomarker of postoperative cognitive dysfunctions. To calculate the sample size, the investigators used values obtained from a previous work in a cohort of 30 patients and decided to compare the prediction ability of MoCA and alpha power ratio. ROC curves and their AUC were used to calculate the prediction ability of MoCA and alpha power ratio. Thus, a sample size of 425 patients was calculated considering an AUC of MoCA = 0.786 and AUC of alpha power = 0.895, a two-tailed test, an alpha error of 0.05 and a power of 0.8 and considering a 25% loss. Investigators consider this study as a pilot validation trial to establish the utility and the capacity of the EEG biomarker for predicting PD and PSSD, the research team aims to include the 25% of the total sample. This yields the need for 106 patients for this preliminary trial.

Interventions

DEVICESedline

Intraoperative EEG monitorization

Sponsors

Masimo Corporation
CollaboratorINDUSTRY
University of Chile
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Delirium and Subsyndromal Delirium5 Postoperative daysIncidence of Delirium and Subsyndromal Delirium in the cohort

Secondary

MeasureTime frameDescription
Delirium Severity5 Postoperative daysDelirium severity assessed by Cognitive Assessment Method - Severity
Delirium DurationPerioperative periodDuration of delirium during the perioperative period
DeathPerioperative periodNumber of deceased patients
ReinterventionPerioperative periodNumber of patients that needed another surgery after primary intervention
Unanticipated ICU hospitalizationPerioperative periodNumber of patients that needed unanticipated intensive care unit (ICU) care
Need for Mechanical Ventilation assistancePerioperative periodNumber of patients that needed mechanical ventilation

Countries

Chile

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026