Validation of the Accuracy of a Novel POCT Dry Electrolyte Analysis System in the Acute Care Setting
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age28+
SponsorZhujiang Hospital
About this trial
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
Qualifiers
Patients who are scheduled to undergo electrolyte measuring in the emergency department (ED) or emergency intensive care unit (ICU).
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Nova Stat Profile pHOx Ultra Analyzer System(Nova)
- Novel POCT dry electrolyte analysis system(P1)
Treatment groups
200 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov