Postoperative Clinical and Neurophysiological Assessment of Patients After Open Heart Surgery

This study aims to investigate postoperative clinical, cognitive and neurophysiological assessment of patients after open heart surgery among sample of Egyptian patients.

Study Overview

• Status: Recruiting
• Conditions: Clinical; Postoperative; Open Heart Surgery; Neurophysiological Assessment
• Intervention / Treatment: Device: Digital Electroencephalography (DEEG)

Detailed Description

Coronary artery bypass grafting (CABAG) is one of the most common major surgical procedures, as more than 800,000 patients worldwide undergo myocardial revascularization procedures every year. Cardiopulmonary bypass (CPB) is an extracorporeal circulation procedure that assists the operation of cardiac and great vessels and is associated with perioperative morbidity and mortality.

Preoperative neurophysiological status as measured by electroencephalogram (EEG) had a specificity of 94.7% and a sensitivity of 76.9% for predicting 1-week postoperative cognitive status and with specificity of 78.3% and a sensitivity of 77.8% for predicting 3-months postoperative cognitive status.

• Study Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

• Study Contact: Name: Osama A Ebrahim, Master; Phone Number: 00201016386372; Email: osamaallam@med.asu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt, 11591
    • Recruiting
    • Ain Shams University
    • Contact: Osama A Ebrahim, Master; Phone Number: 00201016386372; Email: osamaallam@med.asu.edu.eg
    • Sub-Investigator: Mahmoud H EL Rakawy, MD
    • Sub-Investigator: Naglaa M EL Khayat, MD
    • Sub-Investigator: Ahmed A Gaber, MD
    • Sub-Investigator: Yousry A Abdelhamid, MD
    • Sub-Investigator: Adel M ELansary, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This prospective observational study will be conducted on 80 patients undergoing pump open heart surgery, either isolated coronary artery bypass grafting (CABG) or combined CABG and valve surgery, at the Cardiothorathic Academy of Ain Shams University hospitals.

Description

Inclusion Criteria:

• Patient ≥ 60 years.
• Both sexes.
• Patients who are scheduled for on-pump open heart surgery either isolated coronary artery bypass grafting (CABG) or combined CABG and valve surgery.

Exclusion Criteria:

• Patients with a past history of CNS disease (e.g. Epilepsy, brain tumors, or Dementia).
• Patients with metabolic disturbance.
• Illiterate patient.
• Patient with sever cognitive impairment on Mini-mental state Examination (MMSE) and/or Montreal Cognitive Assessment (MoCA)
• Patients who cannot undergo DEEG recordings (eg, uncooperative).
• Patients with abnormal brain images except for small vessel disease.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Study group; Patients who will undergo open heart surgery, such as isolated coronary artery bypass grafting (CABG) or combined CABG and valve surgery.

Device: Digital Electroencephalography (DEEG); The enrolled patients will undergo Digital Electroencephalography (DEEG) monitoring for at least two hours. A senior epileptologist will make a DEEG interpretation to detect DEEG abnormality. DEEG patterns will be categorized according to the American Clinical Neurophysiology Society's standardized critical care DEEG terminology(normal, slowing and asymmetry, sharp and wave, periodic discharges, ictal patterns burst suppression, and electrocerebral silence)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neurological complications	Neurological complications, including nonconvulsive seizures after open heart surgery, will be recorded.	4 months postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Electroencephalography (DEEG) monitoring	The enrolled patients will undergo Digital Electroencephalography (DEEG) monitoring for at least two hours. A senior epileptologist will interpret the DEEG to detect abnormalities. The DEEG patterns will be categorized according to the American Clinical Neurophysiology Society's standardized critical care DEEG terminology(normal, slowing and asymmetry, sharp and wave, periodic discharges, ictal patterns burst suppression, and electrocerebral silence).	24 hours postoperatively

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: November 24, 2024
• First Submitted That Met QC Criteria: November 24, 2024
• First Posted (Estimated): November 27, 2024

Study Record Updates

• Last Update Posted (Estimated): November 27, 2024
• Last Update Submitted That Met QC Criteria: November 24, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: FMASU MD115/2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No