Evaluation of Blood Gas Syringes
Analyze ABS
Post-Market Study Evaluating Analyzer Readings of Multiple Arterial Blood Gas Syringes
1 other identifier
observational
26
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jun 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 26, 2013
CompletedFirst Posted
Study publicly available on registry
September 5, 2013
CompletedSeptember 5, 2013
August 1, 2013
Same day
June 26, 2013
August 30, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Differences in analyte values obtained from three different blood gas syringes for each analyzer tested
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.
Blood analysis within 30 minutes of draw
Study Arms (1)
Healthy Volunteers
Eligibility Criteria
Healthy Volunteers
You may qualify if:
- years of age or older
- Willing and able to independently sign an English Informed Consent
- Have adequate veins for sampling blood from both right and left upper extremities
You may not qualify if:
- Currently taking anti-coagulation medication
- Have a known bloodborne disease or bleeding tendency
- Have a known fear or adverse reaction to needles or blood
- Women who are pregnant or nursing
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Smiths Medical, ASD, Inc.lead
- Bionosticscollaborator
Study Sites (1)
Bionostics
Devens, Massachusetts, 01434, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Lisa Cifaldi, BS, RRT
Smiths Medical
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 26, 2013
First Posted
September 5, 2013
Study Start
June 1, 2013
Primary Completion
June 1, 2013
Study Completion
June 1, 2013
Last Updated
September 5, 2013
Record last verified: 2013-08