Validation of the Accuracy of a Novel POCT Dry Blood Gas Analyzer in Acute Care Settings:A Cross-Sectional Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 216
- 试验地点
- 1
- 主要终点
- Consistency between EG-i30 and ABL90 analyzers for blood gas and biochemical parameters.
研究概览
简要总结
The goal of this observational study is to validate the performance of the novel POCT dry blood gas analyzer EG-i30, against the currently widely used traditional wet blood gas analyzer, Radiometer ABL90, in acute care settings. The main questions it aims to answer are:
- How consistent are the results between EG-i30 and ABL90 in acute care settings, including outliers, correlation, linearity, and bias?
- Whether EG-i30 can be considered a suitable alternative to ABL90 in acute care settings.
Participants will be patients in the emergency department who will undergo simultaneous testing with EG-i30 and ABL90 during their emergency care to assess the performance of EG-i30.
详细描述
This observational study aims to compare the performance of two blood gas analyzers, the EG-i30 dry blood gas analyzer and the ABL90 wet blood gas analyzer, in an emergency department (ED) or emergency intensive care unit (ICU) setting. The study will evaluate the consistency, correlation, and bias between the two analyzers for various blood gas and biochemical parameters, such as Potential of hydrogen (pH), Partial pressure of oxygen (PaO2), Partial pressure of carbon dioxide (PaCO2), Sodium (Na+), Potassium (K+), Chloride (Cl-), Ionized calcium (iCa2+), Lactate (Lac), Glucose (Glu), and Hematocrit (Hct). The study design is observational, with no intervention or treatment assigned to the participants. The comparison will be made using residual blood samples collected as part of routine care, following standard clinical procedures.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 28 Days 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are scheduled to undergo arterial blood gas analysis in the emergency department (ED) or emergency intensive care unit (EICU).
排除标准
- •Patients with a confirmed history of infectious diseases such as hepatitis B, syphilis, HIV/AIDS, etc.
- •Patients whose residual blood samples are not tested within the specified time frame after collection.
- •Other patients deemed ineligible by the investigator (e.g., samples with contamination or other factors affecting sample quality).
结局指标
主要结局
Consistency between EG-i30 and ABL90 analyzers for blood gas and biochemical parameters.
时间窗: Within 2 minutes after arterial blood sample collection
This outcome measures is to evaluate the consistency between the EG-i30 dry blood gas analyzer and the ABL90 wet blood gas analyzer. Consistency will be assessed by comparing the results of blood gas and biochemical parameters (e.g., pH, PaO2, PaCO2, Na+, K+, Cl-, iCa2+, Lac, Glu, and Hct) and will be evaluated using Bland-Altman analysis.
Correlation between EG-i30 and ABL90 analyzers for blood gas and biochemical parameters.
时间窗: Within 2 minutes after arterial blood sample collection
This outcome measures the correlation between the EG-i30 and ABL90 analyzers for blood gas and biochemical parameters (e.g., pH, PaO2, PaCO2, Na+, K+, Cl-, iCa2+, Lac, Glu, and Hct). The correlation will be quantified using Pearson's correlation coefficient.
Bias at clinical decision levels between EG-i30 and ABL90 analyzers.
时间窗: Within 2 minutes after arterial blood sample collection
This outcome measure is to evaluate the bias at clinical decision levels between the EG-i30 and ABL90 analyzers. Bias will be assessed by calculating the difference in the results of key blood gas and biochemical parameters (e.g., pH, PaO2, PaCO2, Na+, K+, Cl-, iCa2+, Lac, Glu, and Hct) between the two analyzers at clinically relevant thresholds. These thresholds will be based on established clinical decision points where treatment decisions are made.
Outlier Detection in Blood Gas and Biochemical Parameters
时间窗: Within 2 minutes after arterial blood sample collection
This outcome measure aims to identify and evaluate outliers in the blood gas and biochemical parameters (e.g., pH, PaO2, PaCO2, Na+, K+, Cl-, iCa2+, Lac, Glu, and Hct) measured by the EG-i30 and ABL90 analyzers. Outliers will be detected using statistical methods such as the Grubbs test or the Interquartile Range (IQR) method. The impact of these outliers on the consistency and accuracy of the measurements will also be assessed.
次要结局
未报告次要终点