NCT01935284

Evaluation of Blood Gas Syringes

Post-Market Study Evaluating Analyzer Readings of Multiple Arterial Blood Gas Syringes

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 26 (actual)
• Sponsor: Smiths Medical, ASD, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Blood Gas Analyte Values

Timeline

• Start date: 2013-06-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2013-09-05
• Last updated: 2013-09-05

Locations

1 site across 1 country: United States