Bionostics
Devens, Massachusetts, 01434, United States
NCT Number: NCT01935284
To assess the interchangeability and agreement between measurements from three blood gas syringes for the collection of blood for the analysis of multiple analytes as measured by differing manufacturers' multi-parameter analyzers.
Looking for future studies?
Notify Me18 year and older
All sexes
Observational
Devens, Massachusetts, 01434, United States
This is a prospective, randomized, post-market study using fresh blood for analysis that is obtained from healthy subject volunteers. Trained phlebotomists will collect blood samples from subjects after confirmation of eligibility criteria. Blood samples will be drawn to fill all study syringe types in a randomized order. Each syringe type will be drawn per subject to analyze each of the available blood parameters in duplicate using three different multi-parameter analyzers. The analytes tested will vary per analyzer capabilities. All blood draws and analyte testing will be performed at an independent laboratory. The study is to confirm that all of the syringes tested provide consistent readings when analyzed using the most common multi-parameter analyzers used in hospital laboratories.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Blood analysis within 30 minutes of draw
For each of the analytes that are tested, the analyte values from each of the three (3) syringe types tested will be compared for each of the three (3) multi-parameter analyzers. Average values for each analyte per patient, syringe and analyzer will be used for the comparison of syringes for each analyzer.
Smiths Medical, ASD, Inc.
Industry
Post-Market Study Evaluating Analyzer Readings of Multiple Arterial Blood Gas Syringes
Acronym: Analyze ABS
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.