NCT03977350

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)

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Neuroindex Ltd. · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cognitive Dysfunction

Interventions

Type	Name	Description
DEVICE	EEG monitoring	EEG monitoring under general anesthesia

Timeline

• Start date: 2019-09-23
• Primary completion: 2021-09-01
• Completion: 2022-12-01
• First posted: 2019-06-06
• Last updated: 2020-09-11

Locations

1 site across 1 country: Israel