ABL90 FLEX PLUS Method Comparison Study for pH, pCO2, pO2, cCa2+, cCl-, cK+, cNa+, cGlu, cLac, ctHb, sO2, FO2Hb, FMetHb, FCOHb and FHHb in Whole Blood in Adult Population.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 754
- 试验地点
- 2
- 主要终点
- Slope, R^2 and bias at medical decision points
研究概览
简要总结
The goal of this clinical trial is to validate performance claims for method comparison for the ABL90 FLEX PLUS for pH, pCO2, pO2, cCa2+, cCl-, cK+, cNa+, cGlu, cLac, ctHb, sO2, FO2Hb, FMetHb, FCOHb and FHHb in heparinized whole blood in a Point of Care (POC) setting.
详细描述
The main question it aims to answer is:
To quantify the relationship using comparison measurement from the same sample between ABL90 FLEX PLUS and the predicate device within the reportable range for all 15 parameters in heparinized arterial and venous patient whole blood in syringe measuring mode (S65, SP65) and heparinized capillary whole blood samples in capillary measuring mode (C65).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
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
- •The subject must be 18 years or older.
- •Informed consent collected from subject or from relative(s) able to understand information given and willing and able to voluntary give their consent to participate in this study.
- •The subject will provide blood samples from the existing Aand/ or V-lines, and/or from a finger stick.
- •Subject evaluated as suitable according to the protocol to enroll in the study by principal investigator or designee.
排除标准
- •Subject where sample collection is evaluated by principal investigator or designee to impose an unnecessary risk.
- •Subject, who is pregnant or breastfeeding.
- •Subject, who has an invalid written informed consent or has withdrawn consent.
- •Subject who has already provided successful measurements of arterial, venous and capillary samples, to cover both syringe modes and the capillary mode
- •Subjects taking medications listed in Appendix 1 with last dose within 72 hours, should be excluded due to interference.
- •Subjects with known infectious disease such as Hepatitis C and HIV (in order to ensure the operator safety).
结局指标
主要结局
Slope, R^2 and bias at medical decision points
时间窗: 6-9 months
Primary Endpoints: Slope, R\^2 and bias at medical decision points for each combination of modes and sample type, across sites
次要结局
未报告次要终点