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

Not yet recruiting

• Conditions: Respiratory Failure; Acid-Base Balance Disorder; Sepsis; Shock; Acute Respiratory Distress Syndrome (ARDS)

• Registration Number: NCT06726473
• Lead Sponsor: Zhujiang Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-04
• Study First Submitted QC: 2024-12-06
• Last Update Submitted: 2024-12-06
• Study First Posted: 2024-12-10
• Last Update Posted: 2024-12-10
• Study Start: 2024-12-20
• Primary Completion: 2025-01-31
• Study Completion: 2025-01-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Consistency between EG-i30 and ABL90 analyzers for blood gas and biochemical parameters.	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.	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.	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	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.

Trial Locations

Locations (1)

Zhujiang Hospital, Southern Medical University Organization; 🇨🇳 Guangzhou, Guangdong, China