Verifying the Accuracy of the Masimo Pronto Non-Invasive Hemoglobin (Hb) Monitor and Associated Rainbow Probes Compared to Measured Laboratory Values in Critically Ill Pediatric Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Comparison of standard hemoglobin monitoring vs. the MASIO non-invasive hemoglobin monitor
研究概览
简要总结
This is a prospective study to determine the accuracy of the Masimo Pronto Non-Invasive Hemoglobin Monitor and associated Rainbow® probes in the detection of hemoglobin concentration in critically ill children.
详细描述
This is a prospective study to determine the accuracy of the Masimo Pronto Non-Invasive Hemoglobin Monitor and associated Rainbow® probes in the detection of hemoglobin concentration in critically ill children. Data from at least 30 patients admitted to the Pediatric Intensive Care Unit (PICU) over a period of 2 months will be collected and analyzed for this study.
Note, that this device would not lead to deviations in routine patient care; specifically, the non-invasive monitor placed on the patient's finger is FDA approved. The proposed monitors are identical macroscopically to monitors, which are currently used to measure oxygen saturation at this institution. Clinical decisions, additional blood draws or alterations to the plan of care will not be made based on study data. The objective is to compare the validity of the hemoglobin values determined from non-invasive technology with measured laboratory values for hemoglobin utilized as standard of care.
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
- 30 Days 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has been admitted to Pediatric Intensive Care Unit
- •Patient age is ≥ 30 days old and ≤ 18 years old
- •Patient weight ≥ 3 Kg.
- •Patient requires hemoglobin monitoring
排除标准
- •Patient does not have exposed fingers/toes,due to congenital anomalies wound dressing or injury.
- •Patient weight is less than 3 Kg
- •Patient is less than 30 days old
结局指标
主要结局
Comparison of standard hemoglobin monitoring vs. the MASIO non-invasive hemoglobin monitor
时间窗: up to 48 hours, post PICU admission
We will obtain measurements using the Masimo Pronto device prior to the standard lab draw at the following time points: post admission to PICU, 12-48 hours. We will then perform analysis using Bland Altman methods to determine the degree of agreement. Data analysis will occur 1 year after enrollment completion.
次要结局
未报告次要终点
研究者
Sean McLean, MD
MD
University of North Carolina, Chapel Hill