Postoperative Clinical and Neurophysiological Assessment of Patients After Open Heart Surgery

NCT06707454 | Recruiting

• 1 other identifier: FMASU MD115/2023
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Postoperative; Clinical; Neurophysiological Assessment; Open Heart Surgery

Outcome Measures

Primary Outcomes (1)

• Neurological complications

  Neurological complications, including nonconvulsive seizures after open heart surgery, will be recorded.

  4 months postoperatively

Secondary Outcomes (1)

• Electroencephalography (DEEG) monitoring

  24 hours postoperatively

Study Arms (1)

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)

Interventions

Digital Electroencephalography (DEEG) DEVICE

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)

Study group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, 11591, Egypt

RECRUITING

Central Study Contacts

Osama A Ebrahim, Master

CONTACT

00201016386372; osamaallam@med.asu.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Neuropsychiatry, Faculty of Medicine, Ain Shams University, Cairo, Egypt

Study Record Dates

• First Submitted: November 24, 2024
• First Posted: November 27, 2024
• Study Start: June 1, 2023
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: November 27, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)