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Sponsored by: |
GE Healthcare |
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Information provided by: | GE Healthcare |
ClinicalTrials.gov Identifier: | NCT00730119 |
This investigation is a multi-center study that will demonstrate that the GE Monitor meets equivalency and/or accuracy and/or performance criteria. This investigation will compare the test device(s) to itself, or one of the reference parameters, or a combination of parameters, including NIBP, temperature, SpO2, respirations, and ECG.
Condition | Intervention |
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Non-Invasive Blood Pressure Temperature SpO2 Respiration ECG |
Device: Measuring vital signs using the GE Monitor |
Study Type: | Observational |
Study Design: | Case-Only, Prospective |
Official Title: | Evaluation Of The GE Monitor Product Line |
Estimated Enrollment: | 1500 |
Study Start Date: | October 2001 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
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N
Neonates
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Device: Measuring vital signs using the GE Monitor
Measuring vital signs (NIBP, SpO2, Temperature, Respiration, and ECG)
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I
Infants
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Device: Measuring vital signs using the GE Monitor
Measuring vital signs (NIBP, SpO2, Temperature, Respiration, and ECG)
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A
Adults
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Device: Measuring vital signs using the GE Monitor
Measuring vital signs (NIBP, SpO2, Temperature, Respiration, and ECG)
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Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
All populations (neonatal, pediatrics, and adults).
Inclusion Criteria:
Exclusion Criteria:
Contact: Andrea Stebor | (813) 887-2035 | dr.andrea.Stebor@ge.com |
Contact: Maria Montserrat | (813) 887-2105 | maria.montserrat@ge.com |
United States, Florida | |
GE Healthcare | Recruiting |
Tampa, Florida, United States, 33614 | |
Contact: Andrea D Stebor, ARNP, PhD 813-887-2035 dr.andrea.Stebor@ge.com | |
Contact: Maria Montserrat (813) 887-2105 maria.montserrat@ge.com |
Study Director: | Andrea D Stebor, ARNP, PhD | GE Healthcare |
Responsible Party: | GE Healthcare ( Andrea D. Stebor, ARNP, PhD, Clinical Research Manager ) |
Study ID Numbers: | CS 327 |
Study First Received: | August 5, 2008 |
Last Updated: | August 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00730119 |
Health Authority: | United States: Institutional Review Board |
Non-invasive Blood Pressure (NIBP) GE Monitor Temperature SpO2 Respiration, ECG |