Validation of a Continuous Noninvasive Haemoglobin Determination Monitor (Radical 7 Pulse CO-Oximeter, SpHb) Compared to the Central Laboratory Coulter (LabHb) and a Point of Care (POC) Invasive Cooximeter (COoxHb) After in Vivo Adjustment.
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Central coulter bias and limits of agreement after in vivo calibration
研究概览
简要总结
Continuous haemoglobin determination could improve the outcomes of several patients in risk of bleeding during surgery. An in vivo calibration has been introduced to the device after our team found its need. The uncalilbrated validation of the Masimo Radical 7 continuous haemoglobin monitor has been made in various papers, although it has been compared to point of care devices, thus introducing an error as such point of care devices although validated for haemoglobin determination, are not as accurate as the gold standard. The validation of the gold standard calibrated device has not been described yet.
When compared to the accepted gold standard (cyanmethemoglobin method, Coulter), accuracy and precision of the continuous haemoglobin monitor could be good enough to be used interchangeably with the gold standard.
详细描述
Continuous haemoglobin determination could improve the outcomes of several patients in risk of bleeding during surgery.
The in vivo calibration has not been adjusted to the gold standard haemoglobin determination in the literature yet.
Two blood samples will be withdrawn at the same time from an arterial line, one for the central laboratory and the other one for the POC device. At the same exact time the SpHb measurement will be recorded. At least eight samples are expected per patient. A maximum of 20 samples will be withdrawn per patient.
To compare bias, precision and limits of agreement among SpHb, LabHb and COoxHb the Bland Altman method will be used with multiple observations per subject when the true value varies. An error grid analysis will be made to know how it could affect to clinical decision making.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients.
- •Surgery duration of at least two hours.
- •Patients scheduled to surgery under general anaesthesia and muscle relaxation.
- •Radial arterial line needed for blood pressure control or other reason not related to the study.
排除标准
- •Radial arterial line not indicated / not possible to place.
- •Sampling difficult or impossible.
- •Need to reposition arterial line arm during surgery.
- •Any illness that could influence the haemoglobin measurement.
结局指标
主要结局
Central coulter bias and limits of agreement after in vivo calibration
时间窗: 3 months
Bias and limits of agreement of SpHb compared to the central laboratory coulter after in vivo Radical 7 calibration
Central coulter bias and limits of agreement
时间窗: 3 months
Bias and limits of agreement of SpHb compared to the central laboratory coulter
次要结局
- POC Cooximeter bias and limits of agreement(3 months)
- POC Cooximeter Coulter interchangeability(3 months)
研究者
Juan Soliveres
MD, PhD
Hospital Universitario Doctor Peset