Non-invasive Continuous Hemoglobin in Pediatric Medicine: a Comparison Between Standard of Care CBC Hemoglobin (ADVIA 2120®) and the New Masimo® SpHb® Neonatal Sensor
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Non-invasive, photoplethysmographic, hemoglobin reading (SpHb®)
研究概览
简要总结
The purpose of this study is to evaluate hemoglobin (Hgb) measurement by Masimo-developed pulse co-oximetry in pediatric patients weighing less than 3 kilograms (Kg).
详细描述
This collaborative study with Masimo Corporation will involve 2 phases. In the first phase of this study, 25 subjects weighing 0.5 to 3.0 kg will be recruited and hemoglobin values will be obtained from the non-invasive probe at the same time as blood samples are routinely drawn for Hgb analysis using the cyanomethemoglobin method (ADVIA 2121). Masimo Corporation will use this data to calibrate or modify the hemoglobin reading (SpHb®) sensors and monitors. All results and conclusions from this phase will be discussed with the investigation team in order to determine if additional subjects are needed (at increments of 25 subjects at a time). Once the sensor designs have been optimized, another group of patients will be studied to document the accuracy and precision of the hemoglobin reading (SpHb®) measurements.
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
- — 至 1 Year（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females weighing 0.5 kg to 3 kg.
- •Neonates and infants and children admitted to the Children's Hospital of Philadelphia (CHOP)operating room (OR), PICU and NICU where hemoglobin measurements are anticipated.
- •Parental/guardian permission (informed consent)
排除标准
- •Subjects where blood samples are obtained through access types other than venous or arterial (e.g: intraosseous).
- •Subject weighing more than 3 kg.
- •Subjects who are too small or with any anatomical limitations that would preclude proper attachment of the adhesive sensor.
- •Any skin rash on the intended site of measurement. Severe allergy to adhesive tapes.
结局指标
主要结局
Non-invasive, photoplethysmographic, hemoglobin reading (SpHb®)
时间窗: up to 5 minutes
The primary endpoint is comparing at least one simultaneous non-invasive, photoplethysmographic, hemoglobin reading (SpHb®) and one invasive hemoglobin measurements (Hb) for each subject. (SpHb® vs. Hb)
次要结局
未报告次要终点