Clinical trial NCT03977350: Association Between qEEG Measure and Post-Operative Cognitive Dysfunction (POCD) and Postoperative Delirium (POD)
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)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cognitive Dysfunction
Lead sponsor: Neuroindex Ltd.
Sponsor class: INDUSTRY
First posted: 2019-06-06
Enrollment: 50
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will consist of male and female adults undergoing cardiac surgery under general anesthesia

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.


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).

Primary outcomes:
measure: The qEEG parameter IS correlation with POCD
timeFrame: 1 week following surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Carmel Medical Center
Study officials:
affiliation: Carmel Medical Center
name: Dror Leviner, Dr.
role: PRINCIPAL_INVESTIGATOR
References: