25010 - ABL90 FLEX PLUS - Precision Capillary Adult - Clinical Study Protocol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Within sample precision for each parameter measured in capillary mode pooled across sites.
研究概览
简要总结
Conducting the ABL90 FLEX PLUS Clinical Precision Study for 15 Parameters in Adult Whole Blood is to validate performance claims for precision in heparinized whole blood for 15 parameters: pH, pCO2, pO2, cCa2+, cCl-, cK+, cNa+, cGlu, cLac, ctHb, sO2, FO2Hb, FMetHb, FCOHb, and FHHb, while being influenced by testing environment that is representative of intended use environment, site variability, and operator variability in a point-of-care (POC) setting.
The investigational device is the ABL90 FLEX PLUS incl. consumables, running SW3.5 MR2, manufactured by Radiometer Medical ApS The study is being conducted in Denmark and in total, a minimum of 30 subjects are to be enrolled to provide successful measurement values from 2 sites.
详细描述
Adult Whole Blood is to validate performance claims for precision in heparinized whole blood for 15 parameters: pH, pCO2, pO2, cCa2+, cCl-, cK+, cNa+, cGlu, cLac, ctHb, sO2, FO2Hb, FMetHb, FCOHb, and FHHb, while being influenced by testing environment that is representative of intended use environment, site variability, and operator variability in a point-of-care (POC) setting.
Capillary blood collected into 2 capillary tubes from 2 distinct finger sticks will be measured on ABL90 FLEX PLUS in the Capillary mode (C65).
The study is designed to collect approximately 30 pairs of samples combined across sites.
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
- 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.
- •Subjects must be able to understand given information and demonstrate willingness and ability to voluntarily give a signed, valid written informed consent to participate in the study.
- •Subject evaluated as suitable according to the protocol to enroll in the study by the 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, with known pregnancy or breastfeeding.
- •Subject, who has an invalid written informed consent or has withdrawn consent.
- •Subjects who have been previously enrolled in the study.
- •Subjects exposed to following substances within the last 72 hours:
- •Acetylsalicylic Acid Sodium Salt at dose equal or above 1 gram/day
- •N-acetylcysteine o Fluorescein dye o Patent Blue dye -
结局指标
主要结局
Within sample precision for each parameter measured in capillary mode pooled across sites.
时间窗: 1 hour
Within sample precision of each parameter (pH, pCO2, pO2, cCa2+, cCl-, cK+, cNa+, cGlu, cLac, ctHb, sO2, FO2Hb, FMetHb, FCOHb and FHHb) using replicate measurements from heparinized whole blood samples measured by intended users in a POC setting.
次要结局
- Within sample precision for each parameter measured in capillary mode per site, if applicable (at least 15 degrees of freedom shall be obtained for the estimate to be statistically meaningful).(1 hour)