Evaluation of Blood Gas Syringes

Completed

• Conditions: Blood Gas Analyte Values

• Registration Number: NCT01935284
• Lead Sponsor: Smiths Medical, ASD, Inc.

Brief 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.

Study Timeline

• Study Start: 2013-06
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Study First Submitted: 2013-06-26
• Status Verified: 2013-08
• Study First Submitted QC: 2013-08-30
• Last Update Submitted: 2013-08-30
• Study First Posted: 2013-09-05
• Last Update Posted: 2013-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

1. 18 years of age or older
2. Willing and able to independently sign an English Informed Consent
3. Have adequate veins for sampling blood from both right and left upper extremities

Exclusion Criteria

1. Currently taking anti-coagulation medication
2. Have a known bloodborne disease or bleeding tendency
3. Have a known fear or adverse reaction to needles or blood
4. Women who are pregnant or nursing

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Differences in analyte values obtained from three different blood gas syringes for each analyzer tested	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.

Trial Locations

Locations (1)

Bionostics; 🇺🇸 Devens, Massachusetts, United States