Respiratory FailureNCT06726473
Validation of the Accuracy of a Novel POCT Dry Blood Gas Analyzer in Acute Care Settings
An observational study of Respiratory Failure and Acid-Base Balance Disorder, run by Zhujiang Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 28 days and older
- Conditions the study is for
- Respiratory Failure, Acid-Base Balance Disorder, Sepsis
- What is being tested?
- Wet Blood Gas Analyzer (ABL90) and Dry Blood Gas Analyzer (EG-i30)
- How many people
- 216 participants
- Where
- 1 siteChina
- Study dates
- 17 Dec 2024to 30 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 28 days and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Patients who are scheduled to undergo arterial blood gas analysis in the emergency department (ED) or emergency intensive care unit (EICU).
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site
Zhujiang Hospital, Southern Medical University Organization
Guangzhou, Guangdong, 510000
About this study
Official title: Validation of the Accuracy of a Novel POCT Dry Blood Gas Analyzer in Acute Care Settings:A Cross-Sectional Study
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:
- How consistent are the results between EG-i30 and ABL90 in acute care settings, including outliers, correlation, linearity, and bias?
- 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.
Read the 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)
- Being tested
- Wet Blood Gas Analyzer (ABL90), Dry Blood Gas Analyzer (EG-i30)
- Keywords
- blood gas analysis, accuracy, EG-i30, Eaglenos
- Medical subject headings
- Respiratory Insufficiency, Sepsis, Shock, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Dry Blood Gas Analyzer (EG-i30) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Within 2 minutes after arterial blood sample collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study start17 Dec 2024
- Primary completion2 Jan 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Respiratory FailureStudies of the same condition, open and under way.
- More trials run by Zhujiang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lixia Yang, Principal investigator, Zhujiang Hospital, Southern Medical University Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06726473
- Sponsor's protocol ID
- 2024-KY-408-01
- Status last verified
- Jan 2025
- First submitted
- 4 Dec 2024
- Last updated
- 18 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD
Publications
Breathnach CS. The development of blood gas analysis. Med Hist. 1972 Jan;16(1):51-62. doi: 10.1017/s0025727300017257. No abstract available.
PubMed 4558439Shapiro BA. The history of pH and blood gas analysis. Respir Care Clin N Am. 1995 Sep;1(1):1-5.
PubMed 9390846Davis 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.
PubMed 23901131
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Accuracy of a Novel POCT Dry Blood Gas Analyzer in Acute Care Settings:A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT06726473
- Acronym / sponsor ID
- 2024-KY-408-01
- Conditions
- Respiratory Failure, Acid-Base Balance Disorder, Sepsis, Shock, Acute Respiratory Distress Syndrome (ARDS)
- Keywords
- blood gas analysis, accuracy, EG-i30, Eaglenos
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Study start
- 17 Dec 2024 (actual)
- Primary completion
- 2 Jan 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 10 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- How consistent are the results between EG-i30 and ABL90 in acute care settings, including outliers, correlation, linearity, and bias?
- 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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: ABL90 Group | – | Diagnostic Test: Wet Blood Gas Analyzer (ABL90)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. |
| Group 2: EG-i30 Group | – | Diagnostic Test: Dry Blood Gas Analyzer (EG-i30)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. |
Who may qualify
- Ages
- 28 days and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Patients who are scheduled to undergo arterial blood gas analysis in the emergency department (ED) or emergency intensive care unit (EICU).
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Group 1: ABL90 Group |
| 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. | Diagnostic test | Group 2: EG-i30 Group |
Primary outcome
Consistency between EG-i30 and ABL90 analyzers for blood gas and biochemical parameters.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2025.
- Background: PubMed 4558439Breathnach CS. The development of blood gas analysis. Med Hist. 1972 Jan;16(1):51-62. doi: 10.1017/s0025727300017257. No abstract available.
- Background: PubMed 9390846Shapiro BA. The history of pH and blood gas analysis. Respir Care Clin N Am. 1995 Sep;1(1):1-5.
- Background: PubMed 23901131Davis 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.
- Individual participant dataSharing planned: Yes. All collected IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lixia Yang principal investigator
Zhujiang Hospital, Southern Medical University Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Failure and Acid-Base Balance Disorder, run by Zhujiang Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Consistency between EG-i30 and ABL90 analyzers for blood gas and biochemical parameters. (time frame: Within 2 minutes after arterial blood sample collection). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06726473, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2025.