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

Zhujiang Hospital

Status: Enrolling

Conditions: Arrhythmia; Stroke; Electrolyte Disorder

Treatments: Diagnostic Test: Nova Stat Profile pHOx Ultra Analyzer System(Nova); Diagnostic Test: Novel POCT dry electrolyte analysis system(P1)

Study type: Observational

Funder types: Other

Identifiers

NCT06726460

2024-KY-405-01

Details and patient eligibility

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.

Full description

This observational study aims to compare the performance of two electrolyte analysis systems, the electrolyte analyzer P1 and the Nova Stat Profile pHOx Ultra Analyzer System, in an emergency department (ED) or emergency intensive care unit (ICU) setting. The study will evaluate the consistency, correlation, and bias between the two electrolyte analysis systems. The study design is observational, with no intervention or treatment assigned to the participants. The comparison will be made using residual blood samples collected as part of routine care, following standard clinical procedures.

Enrollment: 200 estimated patients

Sex: All

Ages: 28+ days old

Volunteers: No Healthy Volunteers

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.

Trial design

200 participants in 2 patient groups

Group 1: Nova Group

Description:

This group involves the use of the Nova Stat Profile pHOx Ultra Analyzer System for measuring serum and whole blood samples. The results obtained from Nova will be compared with those obtained from P1.

Treatment:

Diagnostic Test: Nova Stat Profile pHOx Ultra Analyzer System(Nova)

Group 1: P1 Group

Description:

This group involves the use of the novel POCT dry electrolyte analysis system P1 for measuring serum and whole blood samples. The results obtained from P1 will be compared with those obtained from Nova.

Treatment:

Diagnostic Test: Novel POCT dry electrolyte analysis system(P1)