Association Between qEEG Measure and Post-Operative Cogni... | NCT03977350

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

NCT03977350

Sponsor

Neuroindex Ltd.

Status

Unknown status

Last Update Posted

Sep 11, 2020Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Cognitive Dysfunction

Interventions

EEG monitoring

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 23, 2019Actual

Primary Completion Date

Sep 1, 2021Estimated

Completion Date

Dec 1, 2022Estimated

First Submitted Date

Jun 4, 2019

First Submission Date that Met QC Criteria

Jun 4, 2019

First Posted Date

Jun 6, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 9, 2020

Last Update Posted Date

Sep 11, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients over 65 years undergoing heart surgery		Patients over 65 years undergoing heart surgery under anesthesia, EEG monitored	Device: EEG monitoring

Interventions

Name	Type	Description	Arm Group Labels	Other Names
EEG monitoring	Device	EEG monitoring under general anesthesia	Patients over 65 years undergoing heart surgery

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ester Pri-Or, Nurse CRA	Contact	972-506629699		Ester@neuroindex.com
Tamar A Arens, Dr.	Contact	972543532120		Tamar@neuroindex.com

Overall Officials

Name	Affiliation	Role
Dror Leviner, Dr.	Carmel Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Carmel Medical Center	Recruiting	Haifa		3436212	Israel

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D060825	Cognitive Dysfunction

Ancestor Terms

ID	Term
D003072	Cognition Disorders
D019965	Neurocognitive Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided