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RECRUITING
NCT06726460

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

Sponsor: Zhujiang Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

28 Days - Any

Study Type

OBSERVATIONAL

Enrollment

200

Start Date

2024-12-17

Completion Date

2025-10-31

Last Updated

2025-07-18

Healthy Volunteers

No

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.

Locations (1)

Zhujiang Hospital, Southern Medical University Organization

Guangzhou, Guangdong, China