23001, Clinical Precision and In-use Analyte Stability Study for Four (4) Parameters in Neonate Arterial Blood for PICO70 and SafePICO
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- In-use analyte stability in neonatal arterial blood in PICO70 and safePICO for each parameter, measuring at four testing timepoints.
研究概览
简要总结
The objective is to determine the total (within-lot and between lots) precision for four (4) parameters (pO2, tBil, ctHb and FHbF) in neonatal arterial blood. Furthermore, the objective is to determine the analyte in-use stability for each blood gas syringe in arterial blood for neonatal blood parameters.
In-use analyte stability in neonatal arterial blood in PICO70 and safePICO for each parameter, measuring at four testing timepoints.
It is expected that he precision performance of each parameter is equal to or within the acceptance criteria/performance claim.
The in-use analyte stability measured at four testing timepoint is within the acceptance criteria.
详细描述
The study is a Post-Market Clinical Follow-up (PMCF) randomized unblinded study, to be conducted across two sites in Denmark, using subject whole blood samples from Umbilical cord/placenta to determine the precision and stability for the PICO70/safePICO syringes when measuring four parameters using the RMED ABL90 FLEX PLUS analyzer.
For PICO70 + safePICO: 40 + 40 completed arterial series of samples consisting of 5 syringes are needed: The syringes will be from three different lots (A,B,C) and analyzed at four different time points, T0 min., T15 min., T30 min., T45 min. to cover measurements completed within 0 - 45 minutes.
Both PICO70 and safePICO arterial blood series of samples can be drawn from one subject/placenta, which brings a range of 40 - 80 completed subjects enrolled in total for the study. If subjects are enrolled but not completed according to the protocol such subject will need replacement. Whole blood will be collected from subject cord/placenta in a mother syringe and distributed when relevant into the five (5) PICO70 and five (5) safePICO syringes for measurments.
It can be relevant to collect venous blood if sufficient volume of arterial blood is not available for the cord/placenta blood collection.
The mother syringe will be heparinized. The amount of heparin in the mother syringe will be determined based on the total volume of the samples.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subject must be 18 years of age or older Subject must be pregnant and at least 37 weeks of gestation Subject must be admitted to the hospital maternity ward to give birth vaginally or to undergo cesarian section. Subject must be evaluated by the principal investigator or designee as suitable for the study according to the protocol
排除标准
- •Subjects already enrolled in the study Subjects exposed to either Fluorescein dye or Patent Blue dye with last dose within 72 hours, should be excluded due to potential interference.
结局指标
主要结局
In-use analyte stability in neonatal arterial blood in PICO70 and safePICO for each parameter, measuring at four testing timepoints.
时间窗: One subject delivers blood samples to be measured over time (45 min.)
Furthermore, the objective is to determine the analyte in-use stability for each blood gas syringe in arterial blood for neonatal blood parameters.
Precision in neonatal arterial blood in PICO70 and safePICO for each parameter.
时间窗: One subject delivers blood samples to be measured over time (45 min.)
The objective is to determine the total (within-lot and between lots) precision for four (4) parameters (pO2, tBil, ctHb and FHbF) in neonatal arterial blood.
次要结局
未报告次要终点