ABL90 FLEX PLUS Clinical Precision Study for 15 Parameters in Adult Whole Blood
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Repeatability (SD) in whole blood for each parameter, measuring mode and parameter level, 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 (Figure 1) incl. consumables, running SW3.5 MR2, manufactured by Radiometer Medical ApS The study is being conducted in Denmark and in total, a minimum of 105 subjects are to be enrolled to provide successful measurement values from 3 different sites.
详细描述
The conduct of the clinical study is to determine repeatability of each parameter using replicate measurements from heparinized whole blood samples measured by intended users in syringe, short probe, and capillary modes available for ABL90 FLEX PLUS, in a POC setting.
The study endpoint is repeatability (SD) in whole blood for each parameter, measuring mode and parameter level, pooled across sites. Participating sites are intensive care wards, and the adult patients (≥18 years old ) are admitted to the hospital with low (moderate hypo), normal, or elevated (moderate hyper) concentrations of the 15 parameters covering the reportable range as much as possible. For collecting whole blood samples, the subject is required to have either arterial or Central Venus Catheter (CVK) lines established as part of standard of care to minimize the risk to the patient.
Each sample of 1.5 mL whole blood is used to complete 2 replicates per run (Each sample will be measured twice on the selected mode during 1 run). Samples to be measured in syringe mode are measured from a syringe, or samples to be measured in capillary mode are transferred to capillary tubes from a syringe and measured from a capillary tube.
Part 1:
- Samples collected from 20 subjects (patients).
- 6 samples of whole blood are collected from each subject (3 samples for Run 1 and 3 samples for Run 2).
- Minimum 40 whole blood samples to be measured in S65 syringe mode (20 subjects x 2 samples per subject).
- Minimum 40 whole blood samples to be measured in SP65 short-probe mode (20 subjects x 2 samples per subject).
- Minimum 40 whole blood samples to be measured in C65 capillary mode (20 subjects x 2 samples per subject).
- Minimum 120 whole blood samples to be measured in all 3 modes free of errors. If errors occur, a new sample needs to be collected.
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
- 是
入选标准
- •Subject must be 18 years of age or older.
- •Obtained informed consent 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.
- •Subject shall have an arterial or a CVK line established as a part of the standard care.
- •Subject evaluated as suitable according to the protocol and for the study by the principal investigator or designee.
排除标准
- •Subjects where sample collection is evaluated by principal investigator or designee to impose an unnecessary risk.
- •Subjects, who are pregnant or breastfeeding.
- •Subjects who have been previously enrolled into this study.
- •Subjects taking medications listed in Appendix 1 within 72 hours of the sample collection
- •Subjects with known infectious disease such as Hepatitis C or HIV (to ensure the operator safety)
结局指标
主要结局
Repeatability (SD) in whole blood for each parameter, measuring mode and parameter level, pooled across sites.
时间窗: 4 - 6 hours
Repeatability 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 syringe, short probe, and capillary modes available for ABL90 FLEX PLUS, in a POC setting.
次要结局
未报告次要终点