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Recruiting NCT06726460

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

Trial Parameters

Condition Electrolyte Disorder
Sponsor Zhujiang Hospital
Study Type OBSERVATIONAL
Phase N/A
Enrollment 200
Sex ALL
Min Age 28 Days
Max Age N/A
Start Date 2024-12-17
Completion 2025-08-31
Interventions
Nova Stat Profile pHOx Ultra Analyzer System(Nova)Novel POCT dry electrolyte analysis system(P1)

Brief 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.

Eligibility Criteria

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.

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