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临床试验/NCT02532530
NCT02532530已完成不适用

Peri-operative Monitoring of Regional Cerebral Oxygen Saturation and Onset of Delirium in Cardiac Surgery Patients

Hasselt University1 个研究点 分布在 1 个国家目标入组 103 人开始时间: 2015年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
103
试验地点
1
主要终点
Association between changes in cerebral oxygen saturation and postoperative delirium (preoperative)

研究概览

简要总结

Delirium is an acute brain syndrome characterized by a disturbance in consciousness accompanied by periods of inattention and changes in cognition. Memory impairment, irrelevant speech and disorientation are commonly observed signs and symptoms. Episodes of delirium have been associated with a prolonged hospital stay, functional and cognitive dysfunction and even an increased mortality. Delirium is a common complication in the postoperative setting where the incidence increases with the risk of surgery. The estimated incidence of postoperative delirium after cardiovascular surgery is remarkable, ranging from 31% up to 51%. Diverse preoperative risk factors have been documented for patients undergoing cardiac surgery: age, pre-existing cognitive dysfunction, a history of alcohol abuse and the severity of illness at admission.

An early diagnosis of postoperative delirium is of great importance to prevent long-term cognitive impairment. For this purpose, a highly specific diagnostic monitoring tool should be implemented during perioperative cardiac surgery care. Near infrared spectroscopy (NIRS) provides information on brain oxygenation by quantifying the regional cerebral oxygen saturation (SctO2) at the microvascular level. Recently, two studies showed that preoperative cerebral tissue oxygenation was lower in the cohort of patients that developed delirium postoperatively. Nevertheless, these studies did not investigate whether the onset of postoperative delirium coincided with a change of postoperative SctO2. A relationship between delirium and reduced cerebral blood flow has already been suggested. As such, the occurrence of a postoperative decrease of SctO2 might have been overlooked thus far. Hence, Investigators want to conduct a prospective, interventional study to determine the relationship between postoperative SctO2 and the onset of delirium after cardiac surgery.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
盲法
None

入排标准

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

入选标准

  • •Adult patients (age ≥ 70 years) undergoing elective on-pump cardiac surgery (i.e. valve replacement with or without Coronary artery bypass graft surgery (CABG))
  • •Surgery has to be performed under normothermic conditions
  • •Ability to perform the confusion assessment method for the intensive care unit (CAM-ICU)
  • •Patients willing to provide written informed consent

排除标准

  • •Age < 70 years
  • •Off-pump cardiac surgery
  • •Surgery performed under hypothermic conditions
  • •Duration before extubation > 36 hours
  • •Patients with insufficient knowledge of the Dutch language
  • •Patients using antipsychotics
  • •Patients with a known history of alcohol abuse (consuming two or more units a day)

研究组 & 干预措施

Study group

Other

Adult patients (age ≥ 70 years) undergoing elective on-pump cardiac surgery (i.e. valve replacement with or without 'Coronary Artery Bypass Graft' (CABG) surgery)

干预措施: Near-Infrared Spectroscopy (NIRS) (Device)

结局指标

主要结局

Association between changes in cerebral oxygen saturation and postoperative delirium (preoperative)

时间窗: pre, intra and postoperative measurement of cerebral oxygen saturation (three days)

The primary objective is to investigate if the development of delirium after cardiac surgery coincides with changes of the cerebral oxygen saturation.

次要结局

  • Cerebral autoregulation performance using a COX index(Intraoperative measurement)

研究者

发起方
Hasselt University
申办方类型
Other
责任方
Principal Investigator
主要研究者

prof. dr. Frank Jans

prof. dr.

Hasselt University

研究点 (1)

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