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

NCT06726473 | Completed

• 1 other identifier: 2024-KY-408-01
• Study Type: observational
• Target: 216
• Locations: 1 country
• Sites: 1

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. 1.How consistent are the results between EG-i30 and ABL90 in acute care settings, including outliers, correlation, linearity, and bias?
2. 2.Whether EG-i30 can be considered a suitable alternative to ABL90 in acute care settings.

Conditions

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

Keywords

blood gas analysis; accuracy; EG-i30; Eaglenos

Outcome Measures

Primary Outcomes (4)

• 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.

  Within 2 minutes after arterial blood sample collection

Study Arms (2)

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.

Diagnostic Test: Wet Blood Gas Analyzer (ABL90)

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.

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

Interventions

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

Group 1: ABL90 Group

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.

Group 2: EG-i30 Group

Eligibility Criteria

• Age: 28 Days+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Zhujiang Hospital: lead

Study Sites (1)

Zhujiang Hospital, Southern Medical University Organization

Guangzhou, Guangdong, 510000, China

Location

Related Publications (3)

• Breathnach CS. The development of blood gas analysis. Med Hist. 1972 Jan;16(1):51-62. doi: 10.1017/s0025727300017257. No abstract available.

  PMID: 4558439 BACKGROUND

• Shapiro BA. The history of pH and blood gas analysis. Respir Care Clin N Am. 1995 Sep;1(1):1-5.

  PMID: 9390846 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.

  PMID: 23901131 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

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.

MeSH Terms

Conditions

Respiratory Insufficiency; Sepsis; Shock; Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lung Diseases

Study Officials

• Lixia Yang

  Zhujiang Hospital, Southern Medical University Organization

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2024
• First Posted: December 10, 2024
• Study Start: December 17, 2024
• Primary Completion: January 2, 2025
• Study Completion: June 30, 2025
• Last Updated: July 18, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Starting 6 months after publication
• Access Criteria: 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.

Locations

CN (1)