Observational Clinical Study of the Intravenous Blood Glucose System in Hospitalized Adult Elective or Non-Emergent Surgery and Medical/Surgical Intensive Care Unit Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 5
- 主要终点
- A non-inferior design to demonstrate that the IVBG System is equivalent (non-inferior) to a POC meter with respect to the proportion of glucose measurements that are deemed acceptable using a metric defined in ISO 15197.
研究概览
简要总结
The primary objective of this study is to evaluate the performance and safety of the intravenous blood glucose (IVBG) System relative to point of care (POC) meter performance when each method is compared to the Yellow Springs Instrument (YSI) under various conditions in the operating room (OR), ICU and general ward (GW) in subjects undergoing elective or non-emergent surgery as well as subjects admitted to the medical/surgical ICU. POC meter systems are currently used in the hospital environment to measure blood glucose values. The YSI is an accepted reference standard for assessing POC meter accuracy.
The secondary objective of this study is to evaluate the performance of the IVBG System as compared with the YSI under various conditions in the operating room (OR), intensive care unit (ICU) and general ward (GW) in subjects undergoing elective or non-emergent surgery as well as subjects admitted to the medical/surgical ICU.
详细描述
Subjects will have their glucose values collected from the IVBG System and compared with paired plasma glucose measurements obtained using theYSI with comparative blood samples collected from a CVC, an arterial line or a peripheral vein.
- Blood samples collected per time point: approximately 2ml for waste and1mL for glucose measurement. In the event that a closed blood drawing system is utilized, the waste would be reduced or eliminated.
- The comparative blood samples will be drawn manually at a maximum frequency of once every four hours.
- Sample draws not to exceed 23 per subject for the duration of the study. This includes 18 comparative blood samples and 5 calibration samples to be draw as needed (e.g. recalibration). Including the partial thromboplastin time (PTT) draws described in section 3.1.2, there would be approximately 100 mL or 6.8 tablespoons drawn per subject. In the case where a closed blood drawing system is used consistently, this would be approximately 50 mL or 3.4 tablespoons per subject.
POC meter blood glucose measurements will be performed at the same time as the blood sample draws described above.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •ICU ≥ 24 hours
排除标准
- •transplant Pt
- •brain injury/surgery
- •end stage disease
- •restricted venous access
- •hx of HITT
- •contraindication for anti-coagulation Tx
- •positive pregnancy test
- •in other drug, device, or biologic study
结局指标
主要结局
A non-inferior design to demonstrate that the IVBG System is equivalent (non-inferior) to a POC meter with respect to the proportion of glucose measurements that are deemed acceptable using a metric defined in ISO 15197.
时间窗: During 72 hours of anticipated Sensor dwell time
次要结局
- Accuracy of Device against YSI (Blood Glucose Analyser)(During 72 hours of anticipated Sensor dwell time)