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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Диагностический тест Nova Stat Profile pHOx Ultra Analyzer System(Nova)
  This group involves the use of Nova for measuring serum and whole blood samples. The results from Nova will be compared with those obtained from P1.
• Диагностический тест Novel POCT dry electrolyte analysis system(P1)
  This group involves the use of P1 for measuring serum and whole blood samples. The results from P1 will be compared with those obtained from Nova.

Первичные конечные точки

• Consistency between P1 and Nova system for electrolyte parameters. [Срок оценки: Within 30 minutes of serum sample collection and within 1 minute of whole blood sample collection]
• Correlation between P1 and Nova for electrolyte parameters. [Срок оценки: Within 30 minutes of serum sample collection and within 1 minute of whole blood sample collection]
• Bias at clinical decision levels between P1 and Nova. [Срок оценки: Within 30 minutes of serum sample collection and within 1 minute of whole blood sample collection]
• Outlier Detection in electrolyte Parameters [Срок оценки: Within 30 minutes of serum sample collection and within 1 minute of whole blood sample collection]

Вторичные конечные точки (2)

• Prevalence of abnormal iMg2+ (ionized magnesium) levels in emergency patients. [Срок оценки: Within 30 minutes of serum sample collection and within 1 minute of whole blood sample collection]
• Correlation between iMg2+ (ionized magnesium) and tMg (total magnesium) levels. [Срок оценки: Within 30 minutes of serum sample collection]

Критерии участия

Критерии включения

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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

Китай · 1 центр

• Zhujiang Hospital, Southern Medical University Organization — Гуанчжоу

Публикации

• Khan AI, Pratumvinit B, Jacobs E, Kost GJ, Kary H, Balla J, Shaw J, Milevoj Kopcinovic L, Vaubourdolle M, Oliver P, Jarvis PRE, Pamidi P, Erasmus RT, O'Kelly R, Musaad S, Sandberg S. Point-of-care testing performed by healthcare professionals outside the hospital setting: consensus based recommendations from the IFCC Committee on Point-of-Care Testing (IFCC C-POCT). Clin Chem Lab Med. 2023 Jun 2;6 PMID 37267483
• Shi Q, Ba G, Li K, Mao Z. Is it practical to incorporate point-of-care testing into clinical prediction models for emergency? Intern Emerg Med. 2023 Oct;18(7):2155-2156. doi: 10.1007/s11739-023-03333-5. Epub 2023 Jun 6. No abstract available. PMID 37278909
• Johansson M, Whiss PA. Weak relationship between ionized and total magnesium in serum of patients requiring magnesium status. Biol Trace Elem Res. 2007 Jan;115(1):13-21. doi: 10.1385/BTER:115:1:13. PMID 17406070
• Escuela MP, Guerra M, Anon JM, Martinez-Vizcaino V, Zapatero MD, Garcia-Jalon A, Celaya S. Total and ionized serum magnesium in critically ill patients. Intensive Care Med. 2005 Jan;31(1):151-6. doi: 10.1007/s00134-004-2508-x. Epub 2004 Dec 17. PMID 15605229
• Oost LJ, van der Heijden AAWA, Vermeulen EA, Bos C, Elders PJM, Slieker RC, Kurstjens S, van Berkel M, Hoenderop JGJ, Tack CJ, Beulens JWJ, de Baaij JHF. Serum Magnesium Is Inversely Associated With Heart Failure, Atrial Fibrillation, and Microvascular Complications in Type 2 Diabetes. Diabetes Care. 2021 Aug;44(8):1757-1765. doi: 10.2337/dc21-0236. Epub 2021 Jun 18. PMID 34385344
• Rios FJ, Zou ZG, Harvey AP, Harvey KY, Nosalski R, Anyfanti P, Camargo LL, Lacchini S, Ryazanov AG, Ryazanova L, McGrath S, Guzik TJ, Goodyear CS, Montezano AC, Touyz RM. Chanzyme TRPM7 protects against cardiovascular inflammation and fibrosis. Cardiovasc Res. 2020 Mar 1;116(3):721-735. doi: 10.1093/cvr/cvz164. PMID 31250885
• Yogi A, Callera GE, Antunes TT, Tostes RC, Touyz RM. Transient receptor potential melastatin 7 (TRPM7) cation channels, magnesium and the vascular system in hypertension. Circ J. 2011;75(2):237-45. doi: 10.1253/circj.cj-10-1021. Epub 2010 Dec 7. PMID 21150127
• de Baaij JH, Hoenderop JG, Bindels RJ. Magnesium in man: implications for health and disease. Physiol Rev. 2015 Jan;95(1):1-46. doi: 10.1152/physrev.00012.2014. PMID 25540137

Идентификаторы

NCT: NCT06726460 · 2024-KY-405-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗