N/A
Completed N=66
B40 Non-Invasive Blood Pressure Equivalency Study
Blood Pressure
Source: ClinicalTrials.gov NCT01546285 ↗
Enrolled (actual)
66
Serious AEs
0.0%
Results posted
Jun 2013
Primary outcomePrimary: Difference Between the B40 Monitor and Reference Device DINAMAP PRO1000 on NIBP Measurements — -1.4; -3.3; -3.7 mmHg
Summary
The purpose of this study is to demonstrate equivalency of the GE Healthcare B40 Patient Monitor noninvasive blood pressure (NIBP) parameter compared to the reference device.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Difference Between the B40 Monitor and Reference Device DINAMAP PRO1000 on NIBP Measurements |
-1.4; -3.3; -3.7 | — |
Eligibility Criteria
Inclusion Criteria
- Ability to provide written informed consent or have a legally authorized representative including a parent or guardian provide written informed consent
- Within the age range from older than 3 years old to 75 years old (adult and child)
- Ability to maintain proper placement of cuff and/or probe and/or sensor
Exclusion Criteria
- Neonates (ages 0-29 days) and infants (30 days to 3 years old) shall be excluded
- Any subject deemed too unstable, by clinician's discretion, or for another reason deemed unacceptable for study by the clinician
- Known dysrhythmias (when applicable)
- Known disease state that compromises circulation to the extremity
- Vigorous exercise prior to participating in the study
- Excessive movement or excitability causing false values or no determinations
- Known allergy to latex when latex products will be in contact with subject
- Pregnant females
Data sourced from ClinicalTrials.gov (NCT01546285). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.