New point-of-care dry electrolyte analyzer for emergency patients
Official title: Validation of the Accuracy of a Novel POCT Dry Electrolyte Analysis System in the Acute Care Setting: A Cross-Sectional Study
Run by Zhujiang Hospital · NCT06726460 · Data updated 2026-11-12
This project will test whether a new point-of-care dry electrolyte analyzer (P1) gives results similar to the standard Nova system for people getting electrolyte tests in the emergency department.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 28 Days and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Zhujiang Hospital Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Status | Recruiting |
| Started | December 17, 2024 |
| Main results expected | August 31, 2025 |
| Study ends | October 31, 2025 |
| Registry record updated | July 18, 2025 |
| Trial ID | NCT06726460 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Patients in the emergency department or emergency ICU who are scheduled for electrolyte testing and have routine residual blood samples available for paired testing are ideal candidates.
✕Probably not a fit
Patients excluded for confirmed infectious diseases, missing or delayed residual samples, or those not treated in the study ED/ICU are unlikely to receive any direct benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational comparison uses paired residual blood samples collected during routine emergency care at Zhujiang Hospital to compare a novel POCT dry electrolyte analyzer (P1) with the Nova Stat Profile pHOx Ultra system. Paired measurements will be analyzed for correlation, linearity, bias, consistency, and outliers to determine agreement between devices. The study will also report the prevalence of abnormal ionized magnesium (iMg2+), the correlation between iMg2+ and total magnesium (tMg), and the potential clinical significance of iMg2+ findings. No interventions are assigned and all testing uses samples obtained during standard clinical care in the ED/ICU.
Why it matters
Potential benefit: If P1 matches Nova's performance, patients could get faster bedside electrolyte results that help speed treatment decisions in emergencies.
How similar studies have gone: Previous comparisons of point-of-care electrolyte analyzers with standard laboratory systems have shown mixed but often clinically acceptable agreement, so this work serves as device validation rather than a wholly novel concept.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Zhujiang Hospital, Southern Medical University Organization
Guangzhou, Guangdong, China Recruiting
Study contacts
- Principal investigator: Hua Xie — Zhujiang Hospital, Southern Medical University Organization
- Study coordinator: Hua Xie
- Email: 52528316@qq.com
- Phone: +86 19802050526
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.