Association Between qEEG Measure and Post-Operative Cognitive Dysfunction (POCD) and Postoperative Delirium (POD)

A Blind, Observational, Prospective, Multi -Center, One Arm, Study on the Association Between qEEG Measure and Post-Operative Cognitive Dysfunction (POCD) and Postoperative Delirium (POD)

Cognitive complications after major surgery are a common phenomenon. The incidence of Postoperative Cognitive Dysfunction (POCD), may vary from 5% to 25% in adult patients, depending on different risk factors. Age has been strongly associated with cognitive complications. POCD is a prolonged decline in cognitive function that appears after surgery as compared with preoperative functions. In order to classify evaluate POCD, it requires at least 2 measurements. A baseline, completed before surgery and a second measurement, post surgery.

In light of the high prevalence of POCD and the difficulties in its prediction, NeuroIndex has developed a quantitative EEG system and software that aim to produces risk predictor index (IS) for POCD. This study aims to evaluate the relationship between the software produced predictor index and the actual POCD events. The qEEG will be monitored during the surgery in addition to the routine clinical practice in operating rooms.

POCD will be evaluated using Montreal Cognitive Assessment test (MoCA) prior and post surgery.

Study Overview

• Status: Unknown
• Conditions: Cognitive Dysfunction
• Intervention / Treatment: Device: EEG monitoring

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Ester Pri-Or, Nurse CRA; Phone Number: 972-506629699; Email: Ester@neuroindex.com
• Study Contact Backup: Name: Tamar A Arens, Dr.; Phone Number: 972543532120; Email: Tamar@neuroindex.com

Study Locations

• Israel
  • Haifa, Israel, 3436212
    • Recruiting
    • Carmel Medical Center
    • Contact: Erez Sharoni, Dr; Phone Number: 972-4-8250621; Email: Esharoni@clalit.org.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The study population will consist of male and female adults undergoing cardiac surgery under general anesthesia

Description

Inclusion Criteria:

• Males and females between the ages of 65 or above.
• Subjects with American Society of Anesthesiologists physical status I-III.
• Subjects who are intended to undergo cardiac surgery (CABG or valve replacement) under general anesthesia.
• Surgical procedures scheduled for over 30 minutes.
• Lack of significant hearing disturbances.
• Subjects with ability to read and understand the consent form.

Exclusion Criteria:

• Significant visual impairment so that the pictures of the confusion assessment method could not be interpreted to accurately test to assess delirium.
• Profound dementia or aphasia that interfered with the assessment of cognitive dysfunction (positive delirium in CAM-ICU).
• Patients with a history of stroke.
• Any documented major neurologic or psychiatric dysfunction.
• Pregnant women.
• Long term use of sedative-hypnotic drugs and antidepressant drug.
• Subjects with scalp or skull abnormalities (s/p brain surgery, cranial implants).

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients over 65 years undergoing heart surgery; Patients over 65 years undergoing heart surgery under anesthesia, EEG monitored	Device: EEG monitoring; EEG monitoring under general anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The qEEG parameter IS correlation with POCD	The qEEG parameter IS, which range between 0 and 1, where higher scores are more favorable than lower scores will be evaluated for its correlation with POCD that will be measured by Montreal Cognitive Assessment (MoCA)	1 week following surgery

Collaborators and Investigators

• Sponsor: Neuroindex Ltd.
• Investigators: Principal Investigator: Dror Leviner, Dr., Carmel Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 23, 2019
• Primary Completion (ANTICIPATED): September 1, 2021
• Study Completion (ANTICIPATED): December 1, 2022

Study Registration Dates

• First Submitted: June 4, 2019
• First Submitted That Met QC Criteria: June 4, 2019
• First Posted (ACTUAL): June 6, 2019

Study Record Updates

• Last Update Posted (ACTUAL): September 11, 2020
• Last Update Submitted That Met QC Criteria: September 9, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Postoperative Complications; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Cognition Disorders; Delirium; Cognitive Dysfunction; Postoperative Cognitive Complications
• Other Study ID Numbers: CLD5

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No