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)
1 other identifier
observational
50
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Sep 2019
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 4, 2019
CompletedFirst Posted
Study publicly available on registry
June 6, 2019
CompletedStudy Start
First participant enrolled
September 23, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedSeptember 11, 2020
September 1, 2020
1.9 years
June 4, 2019
September 9, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Patients over 65 years undergoing heart surgery
Patients over 65 years undergoing heart surgery under anesthesia, EEG monitored
Interventions
EEG monitoring under general anesthesia
Eligibility Criteria
The study population will consist of male and female adults undergoing cardiac surgery under general anesthesia
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Neuroindex Ltd.lead
Study Sites (1)
Carmel Medical Center
Haifa, 3436212, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dror Leviner, Dr.
Carmel Medical Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 4, 2019
First Posted
June 6, 2019
Study Start
September 23, 2019
Primary Completion
September 1, 2021
Study Completion
December 1, 2022
Last Updated
September 11, 2020
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will not share