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NCT Number: NCT06726460

Validation of the Accuracy of a Novel POCT Dry Electrolyte Analysis System in the Acute Care Setting

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.

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Key information

Conditions

Electrolyte Disorder Arrhythmia Arrhythmias, Cardiac Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Heart Diseases Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Vascular Diseases

Age range

28 day and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhujiang Hospital, Southern Medical University Organization

Guangzhou, Guangdong, 510000, China

Location status: Recruiting

Location contact

Hua Xie

CONTACT

[email protected]

+86 19802050526

About this study

This observational study aims to compare the performance of two electrolyte analysis systems, the electrolyte analyzer P1 and the Nova Stat Profile pHOx Ultra Analyzer System, in an emergency department (ED) or emergency intensive care unit (ICU) setting. The study will evaluate the consistency, correlation, and bias between the two electrolyte analysis systems. 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who are scheduled to undergo electrolyte measuring in the emergency department (ED) or emergency intensive care unit (ICU).

Exclusion criteria

  • 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.

Treatment and study plan

Nova Stat Profile pHOx Ultra Analyzer System(Nova)

Diagnostic Test

This 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 Test

This 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.

Primary outcomes

  1. Consistency between P1 and Nova system for electrolyte parameters.

    Time frame: Within 30 minutes of serum sample collection and within 1 minute of whole blood sample collection

    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.

  2. Correlation between P1 and Nova for electrolyte parameters.

    Time frame: Within 30 minutes of serum sample collection and within 1 minute of whole blood sample collection

    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

  3. Bias at clinical decision levels between P1 and Nova.

    Time frame: Within 30 minutes of serum sample collection and within 1 minute of whole blood sample collection

    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.

  4. Outlier Detection in electrolyte Parameters

    Time frame: Within 30 minutes of serum sample collection and within 1 minute of whole blood sample collection

    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.

Secondary outcomes

  1. Prevalence of abnormal iMg2+ (ionized magnesium) levels in emergency patients.

    Time frame: Within 30 minutes of serum sample collection and within 1 minute of whole blood sample collection

    This outcome will assess the prevalence of abnormal ionized magnesium (iMg2+) levels in patients admitted to the emergency department or emergency ICU.

  2. Correlation between iMg2+ (ionized magnesium) and tMg (total magnesium) levels.

    Time frame: Within 30 minutes of serum sample collection

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hua Xie

CONTACT

[email protected]

+86 19802050526

Sponsors and collaborators

Lead sponsor

Zhujiang Hospital

Other

Registry information

Official study title

Validation of the Accuracy of a Novel POCT Dry Electrolyte Analysis System in the Acute Care Setting: A Cross-Sectional Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 10, 2024
Registry last updated
Jul 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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