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Recruiting NCT06707454

Postoperative Clinical and Neurophysiological Assessment of Patients After Open Heart Surgery

Observational Postoperative Clinical Neurophysiological Assessment Open Heart Surgery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Digital Electroencephalography (DEEG).
Who it may be relevant to
Registry conditions: Postoperative, Clinical, Neurophysiological Assessment, Open Heart Surgery. Basic parameters: from 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

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.

Interventions

  • 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)

Primary outcome measures

  • Neurological complications [Time frame: 4 months postoperatively]
Secondary outcome measures (1)
  • Electroencephalography (DEEG) monitoring [Time frame: 24 hours postoperatively]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Egypt · 1 center
  • Ain Shams University — Cairo

Identifiers

NCT: NCT06707454 · FMASU MD115/2023

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗