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Evaluation of Blood Gas Syringes

NCT ID: NCT01935284

Last Updated: 2013-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

26 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-06-30

Study Completion Date

2013-06-30

Brief Summary

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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

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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

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Blood Gas Analyte Values

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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Healthy Volunteers

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bionostics

UNKNOWN

Sponsor Role collaborator

Smiths Medical, ASD, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lisa Cifaldi, BS, RRT

Role: PRINCIPAL_INVESTIGATOR

Smiths Medical

Locations

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Bionostics

Devens, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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Analyze ABS

Identifier Type: -

Identifier Source: org_study_id