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临床试验/NCT02478736
NCT02478736已完成不适用

Preoperative Transcranial Doppler as a Predictor for Delirium Following On-pump Cardiac Surgery

Yonsei University1 个研究点 分布在 1 个国家目标入组 175 人开始时间: 2015年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
175
试验地点
1
主要终点
the predictive power of periopertiver rSO2 values regarding postoperative delirium

研究概览

简要总结

Postoperative delirium is an important problem in patients undergoing major cardiac surgery and associated with more complicated hospital course, increased hospital length of stay and total postoperative cost. A study shows that a low preoperative cerebral oximetry (rSO2) is associated with postoperative delirium after on-pump cardiac surgery. Another study showed that patients who underwent cardiac surgery with reduced cerebral blood flow (CBF) velocity in the left middle cerebral artery (MCA) preoperatively are at greater risk for postoperative cognitive dysfunction (POCD). Therefore, the investigators hypothesize that lower perioperative rSO2 and reduced preoperative mean flow velocity (MFV) of MCA are good predictors of the postoperative delirium in the patients undergoing the on-pump cardiac surgery.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
60 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients in the study will be 60 or older undergoing elective major on-pump cardiac surgery

排除标准

  • No communication possible due to a language barrier or deafness
  • Patients diagnosed with neurocognitive disorders or psychiatric diseases (MMSE or Geriatric Depression Scale cannot be checked before surgery)
  • Patients with unstable hemodynamics or intubated before surgery
  • Patients diagnosed with significant (≥ 50%) intracranial stenosis confirmed by CT angiography or MR angiography
  • Patients diagnosed with stroke, TIA or neurologic diseases (e.g. Parkinson's disease, epilepsy, dementia, or taking psychiatric medications d/t psychiatric disorders)

结局指标

主要结局

the predictive power of periopertiver rSO2 values regarding postoperative delirium

时间窗: 7 days from postoperation

To evaluate whether periopertiver MFV of MCA and/or rSO2 can predict postoperative delirium in patients undergoing the on-pump cardiac surgery

the predictive power of perioperative MFV of MCA regarding postoperative delirium

时间窗: 7 days from postoperation

The presence and severity of delirium were assessed with Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) once a day. The investigators plan to evaluate whether perioperative rSO2 and/or MFV of MCA can predict postoperative delirium in patients undergoing the on-pump cardiac surgery and to assess the predictive power of perioperative rSO2/MFV of MCA regarding postoperative delirium. Perioperative rSO2 was observed during surgery (an expected average of 4 hours) and MVF of MCA was measured just before the induction of general anesthesia.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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