Validation of the Accuracy of a Novel POCT Dry Electrolyte Analysis System in the Acute Care Setting
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age28+
SponsorZhujiang Hospital
About this trial
The goal of this study is to compare the performance of a novel Point-of-Care Testing (POCT) dry electrolyte analyzer (P1) with the Nova Stat Profile pHOx Ultra Analyzer System (Nova) in an acute care setting. The main questions it aims to answer are:
1. How consistent are the results between P1 and Nova in the emergency setting, including outliers, correlation, linearity, and bias? 2. Whether P1 can serve as a suitable alternative to Nova in the acute care setting for electrolyte measurement in the emergency environment.
Participants will be patients in the emergency department who will undergo simultaneous measurement with P1 and Nova during their emergency care to assess the performance of both devices.
Additionally, the study will investigate electrolyte levels in emergency patients, focusing on the prevalence of abnormal ionized magnesium (iMg2+) levels, the correlation between iMg2+ and total magnesium (tMg), and the clinical significance of iMg2+ measurement.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients who are scheduled to undergo electrolyte measuring in the emergency department (ED) or emergency intensive care unit (ICU).
Disqualifiers
Patients with a confirmed history of infectious diseases such as hepatitis B, syphilis, HIV/AIDS, etc.
Missing residual sample types (serum or whole blood).
Patients whose residual blood samples are not tested within the specified time frame after collection.
Other patients deemed ineligible by the investigator.
Trial 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 electrolyte measuring.
Trial design
Design model
Other
Time perspective
Cross-sectional
Treatments tested in this trial
Nova Stat Profile pHOx Ultra Analyzer System(Nova)
Diagnostic testThis group involves the use of Nova for measuring serum and whole blood samples. The results from Nova will be compared with those obtained from P1.
Novel POCT dry electrolyte analysis system(P1)
Diagnostic testThis group involves the use of P1 for measuring serum and whole blood samples. The results from P1 will be compared with those obtained from Nova.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Group 1: Nova Group1 intervention
Group B: Group 1: P1 Group1 intervention
Trial outcomes
Primary outcomes
1
Consistency between P1 and Nova system for electrolyte parameters.
This outcome measure is to evaluate the consistency between the novel POCT dry electrolyte analysis system (P1) and the Nova Stat Profile pHOx Ultra Analyzer System (Nova). Consistency will be assessed by comparing the results of electrolyte parameters (e.g., Sodium (Na+), Potassium (K+), Chloride (Cl-), Ionized calcium (iCa2+), Ionized magnesium (iMg2+)) and will be evaluated using Bland-Altman analysis.
Time frame
Within 30 minutes of serum sample collection and within 1 minute of whole blood sample collection2
Correlation between P1 and Nova for electrolyte parameters.
This outcome measures the correlation between P1 and Nova for electrolyte parameters (e.g., Na+, K+, Cl-, iCa2+, iMg2+). The correlation will be quantified using Pearson's correlation coefficient
Time frame
Within 30 minutes of serum sample collection and within 1 minute of whole blood sample collection3
Bias at clinical decision levels between P1 and Nova.
This outcome measure is to evaluate the bias at clinical decision levels between P1 and Nova. Bias will be assessed by calculating the difference in the results of key electrolyte parameters (e.g., Na+, K+, Cl-, iCa2+, iMg2+) between the two analysis system at clinically relevant thresholds. These thresholds will be based on established clinical decision points where treatment decisions are made.
Time frame
Within 30 minutes of serum sample collection and within 1 minute of whole blood sample collection4
Outlier Detection in electrolyte Parameters
This outcome measure aims to identify and evaluate outliers in the electrolyte parameters measured by P1 and Nova. 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.
Time frame
Within 30 minutes of serum sample collection and within 1 minute of whole blood sample collectionSecondary outcomes
1
Prevalence of abnormal iMg2+ (ionized magnesium) levels in emergency patients.
This outcome will assess the prevalence of abnormal ionized magnesium (iMg2+) levels in patients admitted to the emergency department or emergency ICU.
Time frame
Within 30 minutes of serum sample collection and within 1 minute of whole blood sample collection2
Correlation between iMg2+ (ionized magnesium) and tMg (total magnesium) levels.
This outcome will evaluate the correlation between ionized magnesium (iMg2+) levels and total magnesium (tMg) levels, with tMg levels obtained from central laboratory test results, in emergency patients.
Time frame
Within 30 minutes of serum sample collectionSponsors and contacts
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Source ClinicalTrials.gov