跳至主要内容
临床试验/NCT06707454
NCT06707454招募中不适用

Postoperative Clinical and Neurophysiological Assessment of Patients After Open Heart Surgery

Ain Shams University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2023年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
80
试验地点
1
主要终点
Neurological complications

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Neurological complications

时间窗: 4 months postoperatively

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

次要结局

  • Electroencephalography (DEEG) monitoring(24 hours postoperatively)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Osama Allam Ebrahim

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

Ain Shams University

研究点 (1)

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