Completed
NCT Number: NCT02897154
Clinical Evaluation of i-STAT Analyzer Glucose, Hematocrit and Sodium for Capillary Samples
The objective of this study is to compare the performance of two i-STAT Analyzers in a Point-of-Care (POC) setting. The evaluation will be performed using a cartridge to test glucose, hematocrit and sodium on capillary specimens.
Completed
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Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
Diablo Clinical Research, Walnut Creek, California, United States
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About this study
The clinical performance for glucose, hematocrit and sodium assays for capillary samples was evaluated for the investigational i-STAT 500 (Alinity) analyzer based on results of method comparison testing against the i-STAT 1W analyzer.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Subject is ≥ 18 years of age
- Subjects (or their legal representative) who are willing to voluntarily consent to the study
Exclusion criteria
- There are no exclusion criteria
Treatment and study plan
Primary outcomes
-
Glucose (mg/dL) levels
Time frame: Patient's blood is tested within 3 minutes of blood collection
Data analysis
-
Hematocrit (%PCV) levels
Time frame: Patient's blood is tested within 3 minutes of blood collection
Data analysis
-
Sodium (mmol/L) levels
Time frame: Patient's blood is tested within 3 minutes of blood collection
Data analysis
Sponsors and collaborators
Lead sponsor
Abbott Point of Care
Industry
Registry information
Official study title
Clinical Evaluation of i-STAT Analyzer for Glucose, Hematocrit and Sodium
Important dates
- Study start
- 2016
- Primary completion
- 2017
- Study completion
- 2017
- First posted
- Sep 13, 2016
- Registry last updated
- Mar 20, 2018
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.