Validation of the Accuracy of a Novel POCT Dry Electrolyte Analysis System in the Acute Care Setting: A Cross-Sectional Study

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 28 days
Healthy Volunteers: f
View:

• Patients who are scheduled to undergo electrolyte measuring in the emergency department (ED) or emergency intensive care unit (ICU).

Locations
Other Locations
China
Zhujiang Hospital, Southern Medical University Organization
RECRUITING
Guangzhou
Contact Information
Primary
Hua Xie
52528316@qq.com
+86 19802050526
Time Frame
Start Date: 2024-12-17
Estimated Completion Date: 2025-10-31
Participants
Target number of participants: 200
Treatments
Group 1: Nova Group
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.
Group 1: P1 Group
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.
Related Therapeutic Areas
Sponsors
Leads: Zhujiang Hospital

This content was sourced from clinicaltrials.gov