Evaluation of Blood Gas Syringes (Analyze ABS)

Smiths Medical

Status: Completed

Conditions: Blood Gas Analyte Values

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT01935284

Analyze ABS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 26 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

26 participants in 1 patient group

Healthy Volunteers