Clinical trial NCT06726460: Validation of the Accuracy of a Novel POCT Dry Electrolyte Analysis System in the Acute Care Setting
Official title: Validation of the Accuracy of a Novel POCT Dry Electrolyte Analysis System in the Acute Care Setting: A Cross-Sectional Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Electrolyte Disorder
Arrhythmia
Stroke
Keywords: Electrolyte Analyzer
Accuracy
P1
Eaglenos
Lead sponsor: Zhujiang Hospital
Sponsor class: OTHER
First posted: 2024-12-10
Enrollment: 200
Sex: ALL
Minimum age (years): 28
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consists of patients presenting to the emergency department (ED) or admitted to the emergency intensive care unit (ICU) who are scheduled to undergo electrolyte measuring.

Brief 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.

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: Consistency between P1 and Nova system for electrolyte parameters.
timeFrame: Within 30 minutes of serum sample collection and within 1 minute of whole blood sample collection
measure: Correlation between P1 and Nova for electrolyte parameters.
timeFrame: Within 30 minutes of serum sample collection and within 1 minute of whole blood sample collection
measure: Bias at clinical decision levels between P1 and Nova.
timeFrame: Within 30 minutes of serum sample collection and within 1 minute of whole blood sample collection
measure: Outlier Detection in electrolyte Parameters
timeFrame: Within 30 minutes of serum sample collection and within 1 minute of whole blood sample collection
Secondary outcomes:
measure: Prevalence of abnormal iMg2+ (ionized magnesium) levels in emergency patients.
timeFrame: Within 30 minutes of serum sample collection and within 1 minute of whole blood sample collection
measure: Correlation between iMg2+ (ionized magnesium) and tMg (total magnesium) levels.
timeFrame: Within 30 minutes of serum sample collection
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhujiang Hospital, Southern Medical University Organization
state: Guangdong
Study officials:
affiliation: Zhujiang Hospital, Southern Medical University Organization
name: Hua Xie
role: PRINCIPAL_INVESTIGATOR
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