Actively Recruiting
Validation of the Accuracy of a Novel POCT Dry Electrolyte Analysis System in the Acute Care Setting
Led by Zhujiang Hospital · Updated on 2025-07-18
200
Participants Needed
1
Research Sites
45 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Validation of the Accuracy of a Novel POCT Dry Electrolyte Analysis System in the Acute Care Setting
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients who are scheduled to undergo electrolyte measuring in the emergency department (ED) or emergency intensive care unit (ICU).
You will not qualify if you...
- 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.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Zhujiang Hospital, Southern Medical University Organization
Guangzhou, Guangdong, China, 510000
Actively Recruiting
Research Team
H
Hua Xie
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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