Clinical trial NCT06726473: Validation of the Accuracy of a Novel POCT Dry Blood Gas Analyzer in Acute Care Settings
Official title: Validation of the Accuracy of a Novel POCT Dry Blood Gas Analyzer in Acute Care Settings:A Cross-Sectional Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Respiratory Failure
Acid-Base Balance Disorder
Sepsis
Shock
Acute Respiratory Distress Syndrome (ARDS)
Keywords: blood gas analysis
accuracy
EG-i30
Eaglenos
Lead sponsor: Zhujiang Hospital
Sponsor class: OTHER
First posted: 2024-12-10
Enrollment: 200
Sex: ALL
Minimum age (years): 28
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Consistency between EG-i30 and ABL90 analyzers for blood gas and biochemical parameters.
timeFrame: Within 2 minutes after arterial blood sample collection
measure: Correlation between EG-i30 and ABL90 analyzers for blood gas and biochemical parameters.
timeFrame: Within 2 minutes after arterial blood sample collection
measure: Bias at clinical decision levels between EG-i30 and ABL90 analyzers.
timeFrame: Within 2 minutes after arterial blood sample collection
measure: Outlier Detection in Blood Gas and Biochemical Parameters
timeFrame: Within 2 minutes after arterial blood sample collection
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhujiang Hospital, Southern Medical University Organization
state: Guangdong
Study officials:
affiliation: Zhujiang Hospital, Southern Medical University Organization
name: Lixia Yang
role: PRINCIPAL_INVESTIGATOR
References:
citation: Breathnach CS. The development of blood gas analysis. Med Hist. 1972 Jan;16(1):51-62. doi: 10.1017/s0025727300017257. No abstract available.
citation: Shapiro BA. The history of pH and blood gas analysis. Respir Care Clin N Am. 1995 Sep;1(1):1-5.
citation: 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.