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

Recruitingn/aAges 28 Days - anyAllZhujiang Hospital
NCT06726460 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 i

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📋 Eligibility rules (as published)
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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What it tests

  • Nova Stat Profile pHOx Ultra Analyzer System(Nova)
  • Novel POCT dry electrolyte analysis system(P1)
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Where

1 site
Zhujiang Hospital, Southern Medical University Organization
Guangzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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