NCT01256749已完成不适用
A Comparative Study of Global 12 Lead Electroencephalogram to Frontal SedlineTM Electroencephalogram Monitoring for the Evaluation of Intraoperative Burst Suppression During Elective Craniotomy or Transphenoidal Pituitary Resection
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Correlation between 4 channel PSA EEG and a global 12 lead EEG
研究概览
简要总结
The fundamental reason for comparing the ability of the Frontal Sedline TM Electroencephalogram (PSA EEG) to standard Global 12 Lead Electroencephalogram (EEG) for burst suppression detection is to determine if a less expensive, less invasive and possibly more convenient bifrontal EEG monitor can be effective for evaluation of anesthesia-induced intraoperative burst suppression therapy (IBST) for cerebral protection.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult ASA class 1-3 male or female 18-90 years of age;
- •scheduled for elective craniotomy in the LLUMC University Hospital, for which the surgeon has requested intraoperative burst suppression therapy;
- •capable of understanding and signing informed consent;
- •willing to have dual EEG monitoring.
排除标准
- •Age under 18 years;
- •emergency or trauma situation requiring craniotomy;
- •surgical approach that prohibits placing the SEDLineTM array on the forehead;
- •known sensitivity to the adhesives on the SEDLineTM array;
- •lack of availability of standard EEG monitoring;
- •patients with seizure disorders and refusal of consent.
结局指标
主要结局
Correlation between 4 channel PSA EEG and a global 12 lead EEG
时间窗: 24 hours
The primary outcome measure is correlation between 4 channel frontal PSA EEG pattern and standard global 12 lead EEG during IBST.
次要结局
未报告次要终点
研究者
Deborah McIvor, MD
MD
Loma Linda University
研究点 (1)
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