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

Cognitive Dysfunction Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03977350
• Other study ID #: CLD5
• Status: Recruiting
• Start date: September 23, 2019
• Est. completion date: December 1, 2022

Study information

• Verified date: September 2020
• Source: Neuroindex Ltd.
• Contact: Ester Pri-Or, Nurse CRA
• Phone: 972-506629699
• Email: Ester[@]neuroindex.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 1, 2022
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Delirium

Intervention

Device:
• EEG monitoring
EEG monitoring under general anesthesia

Locations

Country	Name	City	State
Israel	Carmel Medical Center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Neuroindex Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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