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Postoperative Clinical and Neurophysiological Assessment of Patients After Open Heart Surgery

NCT ID: NCT06707454

Last Updated: 2024-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-01

Study Completion Date

2025-05-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Postoperative Clinical Neurophysiological Assessment Open Heart Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Study group

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

Digital Electroencephalography (DEEG)

Intervention Type 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)

Interventions

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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)

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Osama Allam Ebrahim

Assistant Lecturer of Neuropsychiatry, Faculty of Medicine, Ain Shams University, Cairo, Egypt

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ain Shams University

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Osama A Ebrahim, Master

Role: CONTACT

[email protected]
00201016386372

Facility Contacts

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Osama A Ebrahim, Master

Role: primary

[email protected]
00201016386372

Other Identifiers

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FMASU MD115/2023

Identifier Type: -

Identifier Source: org_study_id