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NCT Number: NCT06726473

Validation of the Accuracy of a Novel POCT Dry Blood Gas Analyzer in Acute Care Settings

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:

1. How consistent are the results between EG-i30 and ABL90 in acute care settings, including outliers, correlation, linearity, and bias? 2. 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.

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Key information

Conditions

Respiratory Failure Acid-Base Balance Disorder Acute Respiratory Distress Syndrome (ARDS) Infections Inflammation Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Distress Syndrome Respiratory Insufficiency Respiratory Tract Diseases Sepsis Shock Systemic Inflammatory Response Syndrome

Age range

28 day and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhujiang Hospital, Southern Medical University Organization

Guangzhou, Guangdong, 510000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who are scheduled to undergo arterial blood gas analysis in the emergency department (ED) or emergency intensive care unit (EICU).

Exclusion criteria

  • 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).

Treatment and study plan

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

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.

Primary outcomes

  1. Consistency between EG-i30 and ABL90 analyzers for blood gas and biochemical parameters.

    Time frame: 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.

  2. Correlation between EG-i30 and ABL90 analyzers for blood gas and biochemical parameters.

    Time frame: 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.

  3. Bias at clinical decision levels between EG-i30 and ABL90 analyzers.

    Time frame: 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.

  4. Outlier Detection in Blood Gas and Biochemical Parameters

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Zhujiang Hospital

Other

Registry information

Official study title

Validation of the Accuracy of a Novel POCT Dry Blood Gas Analyzer in Acute Care Settings:A Cross-Sectional Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 10, 2024
Registry last updated
Jul 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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