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

Zhujiang Hospital

Status: Completed

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

Treatments: Diagnostic Test: Wet Blood Gas Analyzer (ABL90); Diagnostic Test: Dry Blood Gas Analyzer (EG-i30)

Study type: Observational

Funder types: Other

Identifiers

NCT06726473

2024-KY-408-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 216 patients

Sex: All

Ages: 28+ days old

Volunteers: No Healthy Volunteers

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).

Trial design

216 participants in 2 patient groups

Group 1: ABL90 Group

Description:

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.

Treatment:

Diagnostic Test: Wet Blood Gas Analyzer (ABL90)

Group 2: EG-i30 Group

Description:

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.

Treatment:

Diagnostic Test: Dry Blood Gas Analyzer (EG-i30)