NCT06726473

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 216 (actual)
• Sponsor: Zhujiang Hospital · Academic / Other
• Sex: All
• Age: 28 Days
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Wet Blood Gas Analyzer (ABL90)	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
DIAGNOSTIC_TEST	Dry Blood Gas Analyzer (EG-i30)	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.

Timeline

• Start date: 2024-12-17
• Primary completion: 2025-01-02
• Completion: 2025-06-30
• First posted: 2024-12-10
• Last updated: 2025-07-18

Locations

1 site across 1 country: China