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

NCT06726460 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2025-07-18

No results posted yet for this study

Summary

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.

Conditions

Interventions

DIAGNOSTIC_TEST

Nova Stat Profile pHOx Ultra Analyzer System(Nova)

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.

DIAGNOSTIC_TEST

Novel POCT dry electrolyte analysis system(P1)

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.

Sponsors & Collaborators

  • Zhujiang Hospital

    lead OTHER

Principal Investigators

  • Hua Xie · Zhujiang Hospital, Southern Medical University Organization

Eligibility

Min Age
28 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-17
Primary Completion
2025-08-31
Completion
2025-10-31

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06726460 on ClinicalTrials.gov