NCT01720381已完成不适用
Manual vs. Automated moNitoring Accuracy of GlucosE II (MANAGE II)
OptiScan Biomedical Corporation1 个研究点 分布在 1 个国家目标入组 98 人开始时间: 2012年7月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Glucose Prediction error
研究概览
简要总结
The study is to demonstrate the accuracy of the OptiScanner in measuring blood glucose levels in critically ill patients when compared to a reference YSI 2300 STAT Plus and the Gem 3000, the reference standard for Erasme University Hospital.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed Informed consent.
- •Age ≥ 18 years.
- •Admitted to the ICU of Erasme University Hospital.
- •Expected ICU stay of ≥ 3 days at the time of enrollment (as judged by the Principle Investigator).
- •APACHE II score of ≥ 10, within the first 24 hours of ICU admission.
- •Existing central venous catheter + arterial catheter.
- •No participation in any other investigational interventional study while enrolled in this study.
- •Hyperglycemia (BG > 150 mg/dl) at the time of admission.
排除标准
- •Pregnancy.
结局指标
主要结局
Glucose Prediction error
时间窗: 1 year
Percent (%) predicted error is the percent (%) error result of the OptiScanner on central venous blood from the superior cava versus the YSI and the GEM using arterial blood.
次要结局
- Clarke Error Grid analysis(1 year)
研究者
研究点 (1)
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