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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:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: ABL90 Group | Blood gas and biochemical measurements are performed using the ABL90 blood gas analyzer. The results will be compared with those from the EG-i30 analyzer. |
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| Group 2: EG-i30 Group | Blood gas and biochemical measurements are performed using the EG-i30 blood gas analyzer. The results will be compared with those from the ABL90 analyzer. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wet Blood Gas Analyzer (ABL90) | Diagnostic Test | This group involves the use of the ABL90 wet blood gas analyzer for measuring arterial whole blood samples. The results obtained from the ABL90 analyzer will be compared with those obtained from the EG-i30 dry blood gas analyzer |
| Measure | Description | Time Frame |
|---|---|---|
| Consistency between EG-i30 and ABL90 analyzers for blood gas and biochemical parameters. | 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. | Within 2 minutes after arterial blood sample collection |
| Correlation between EG-i30 and ABL90 analyzers for blood gas and biochemical parameters. | 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. | Within 2 minutes after arterial blood sample collection |
| Bias at clinical decision levels between EG-i30 and ABL90 analyzers. | 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. | Within 2 minutes after arterial blood sample collection |
| Outlier Detection in Blood Gas and Biochemical Parameters | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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The study population consists of patients presenting to the emergency department (ED) or admitted to the emergency intensive care unit (ICU) who are scheduled to undergo arterial blood gas analysis.
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| Name | Affiliation | Role |
|---|---|---|
| Lixia Yang | Zhujiang Hospital, Southern Medical University Organization | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhujiang Hospital, Southern Medical University Organization | Guangzhou | Guangdong | 510000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 4558439 | Background | Breathnach CS. The development of blood gas analysis. Med Hist. 1972 Jan;16(1):51-62. doi: 10.1017/s0025727300017257. No abstract available. | |
| 9390846 | Background | Shapiro BA. The history of pH and blood gas analysis. Respir Care Clin N Am. 1995 Sep;1(1):1-5. |
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All collected IPD
Starting 6 months after publication
Data will be made available to qualified researchers upon submission of a research proposal and execution of a data use agreement. Data access will be granted after the final study results are published and after an ethical review by the institution's ethics board. Data sharing will be coordinated via email. Qualified researchers can contact zjyyllxs@126.com to request access to the data.
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| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| D018805 | Sepsis |
| D012769 | Shock |
| D012128 | Respiratory Distress Syndrome |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
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Arterial whole blood samples from patients who require blood gas analysis as part of their clinical care will be used. After initial analysis using the ABL90 blood gas analyzer, the remaining samples will be measured with the EG-i30 analyzer for comparison. No DNA will be extracted from these samples, and they will be retained only for the purpose of this study.
| Dry Blood Gas Analyzer (EG-i30) | Diagnostic Test | This group involves the use of the EG-i30 dry blood gas analyzer for measuring arterial whole blood samples. The results obtained from the EG-i30 analyzer will be compared with those obtained from the ABL90 wet blood gas analyzer. |
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| Within 2 minutes after arterial blood sample collection |
| 23901131 | Background | Davis MD, Walsh BK, Sittig SE, Restrepo RD. AARC clinical practice guideline: blood gas analysis and hemoximetry: 2013. Respir Care. 2013 Oct;58(10):1694-703. doi: 10.4187/respcare.02786. Epub 2013 Jul 30. |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008171 | Lung Diseases |