Electroencephalographic Biomarker to Predict Postoperative Delirium

Postoperative Delirium Clinical Trial

Official title:

Electroencephalographic Biomarker to Predict the Development of Postoperative Delirium: a Protocol of an Observational Study in a Cohort of Patients From Five Centers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05992506
• Other study ID #: IT21I0041
• Status: Recruiting
• Start date: September 1, 2023
• Est. completion date: June 30, 2026

Study information

• Verified date: August 2023
• Source: University of Chile
• Contact: Jose I Egana, MD, PhD
• Phone: +56 2 2978 8209
• Email: jiegana[@]uchile.cl
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

Acute post-operatory cognitive dysfunction states are one of the most frequent complications in older patients after surgery, being POD the most important. Previous studies have shown than the incidence of POD in older patients range between 10-50%. Patients who develop POD have poorer long-term outcomes, such as longer length of hospital stay, institutionalization at discharge, and even higher mortality. Consequently, the human and economic costs associated to POD represents an important issue for health systems worldwide.

A key element to diminish POD and its burden on healthcare is early diagnostic. Current risk assessment tools are centered on clinical approaches based on cognitive tests (i.e., MoCA) and/or prediction models that uses patients' clinical variables (i.e., DELPHI score). We have developed a strategy that uses intraoperative EEG features as building blocks for a new POD risk assessment predictive model. This system, called PEUMA, uses data obtained from 95 patients from a previous study (NCT04214496).

This will be a multicenter (five-centers), observational study and its primary outcome will be PEUMA's ability to predict POD.

To calculate the sample size, the methodology described by Riley et al was used. This method is specially designed for clinical prediction models. Such a tool is available online (https://mvansmeden.shinyapps.io/BeyondEPV/). The parameters used were the following:

• Number of predictor candidates: 4

• Fraction of events: 0.22. 22% was used because it is the incidence of POD in the analysis of the preliminary data of the first stage and these are in the reporting range common worldwide.

• Estimation error of the classifier: 0.06. The authors suggest prediction errors small when evaluating binary outcomes (Yes POD/No POD) The calculation indicates a sample size of 240 patients. Considering a loss of 10% (in the preliminary results of the first stage the loss was 8%), the sample size is 264 patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 264
• Est. completion date: June 30, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 100 Years

Eligibility

Inclusion Criteria:

• 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

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

Related Conditions & MeSH terms

• Delirium
• Emergence Delirium
• Postoperative Delirium

Intervention

Diagnostic Test:
• POD risk estimation using PEUMA
A software will analyze intraoperative EEG recording for the estimation of a POD Risk Index

Locations

Country	Name	City	State
Chile	Hospital Clinico Universidad de Chile	Santiago
Chile	Instituto Nacional del Cancer	Santiago

Sponsors (5)

Lead Sponsor	Collaborator
University of Chile	Clinica Santa Maria, Hospital Base San Jose Osorno, Instituto Nacional del Cancer, Chile, Pontificia Universidad Catolica de Chile

Country where clinical trial is conducted

Chile, 

References & Publications (3)

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. — View Citation

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 availabl — View Citation

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;1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative Delirium	Incidence of POD in the cohort diagnosed using the Confusion Assessment Method (CAM) twice/day	First 3 days after surgery
Secondary	Death	Number of deceased patients	30 days after surgery
Secondary	Delirium Severity	Delirium severity assessed by Cognitive Assessment Method - Severity (CAM-S)	First 3 days after surgery
Secondary	Delirium Duration	Duration of delirium during the postoperative period	First 3 days after surgery
Secondary	Need for Mechanical Ventilation	Number of patients that needed mechanical ventilation	First 3 days after surgery
Secondary	Reintervention	Number of patients who required other unanticipated surgery after the primary intervention	First 3 days after surgery
Secondary	Unanticipated ICU hospitalization	Number of patients that needed unanticipated intensive care unit (ICU) care	First 3 days after surgery