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临床试验/NCT00151307
NCT00151307终止2 期

The Effects of Monitoring and Maintaining Cerebral Oxygen Saturation on Neuropsychological Outcomes in Patients Undergoing Cardiac Surgery

Weill Medical College of Cornell University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2001年2月最近更新:
适应症

试验速览

阶段
2 期
状态
终止
入组人数
200
试验地点
1
主要终点
Neuropsychological Outcome

研究概览

简要总结

The purpose of this study is to evaluate the effects of maintaining adequate cerebral oxygen saturation (over 40%) on patients undergoing cardiac surgery. Effects on neuropsychological outcome, length of ICU stay, and length of hospital stay will be measured.

详细描述

Central nervous system dysfunction is a major cause of morbidity after cardiac surgery. This study seeks to evaluate the effects of cerebral oxygen saturation on the neuropsychological outcome of cardiac surgery patients. Currently, monitoring of cerebral oxygen saturation levels is not part of routine and standard practice.

Subjects will be assigned to a control and intervention group. Anesthesia and surgery will be performed as per usual standards of care. Patients in both groups will be monitored with an oxygen sensor placed over the forehead. The data will be recorded continuously on a floppy disk. The control group will be treated according to current standard of care; the readings of brain oxygen saturation will not be visible to the clinician. In the intervention group, the reading of brain oxygen saturation will be monitored by the anesthesiologist throughout surgery. Interventions will be performed to maintain cerebral oxygen saturations above 40%. Neuropsychological tests will be completed pre-operatively and at two time points post-operatively. The tests used are the ASEM (antisaccadic eye movement) and the MMSE (mini-mental state examination).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patient
  • Elective cardiac surgery with cardiopulmonary bypass
  • Coronary artery disease or valvular heart disease or combination of both
  • Ability and willingness to give informed consent

排除标准

  • Pediatric patients
  • Emergency surgery
  • Unable to understand English
  • Allergic to tape used to attach oxygen sensor

结局指标

主要结局

Neuropsychological Outcome

Tests:

Anti-saccadic eye movement

Mini-mental state examination

Neurological testing

Completed pre-operatively, 3-4 days post-op, 2-3 months post-op

次要结局

  • ICU & Hospital length of stay
  • Morbidity (complications post-op)
  • Mortality

研究者

申办方类型
Other

研究点 (1)

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