Non-Invasive Blood Pressure
Conditions
Keywords
Non-invasive Blood Pressure (NIBP), GE Dinamap, SuperSTAT
Brief summary
The accuracy and/or performance of the GE DINAMAP noninvasive blood pressure (NIBP) monitors may be improved with modifications in software and/or hardware monitoring techniques and/or accessories. When changes are being made to the GE Monitor, testing can be done to evaluate performance of the investigational devices during and/or after product development.
Interventions
DEVICEGE DINAMAP with SuperSTAT algorithm monitor
Apply cuff on a limb, cuff is inflated and deflated, monitor will displays non-invasive blood pressure values (systolic, diastolic, MAP, and pulse rate)
Sponsors
GE Healthcare
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 3 Years
Healthy volunteers
Yes
Inclusion criteria
* Signed informed consent * Ability to single or dual monitor NIBP, ECG, and/or SpO2, whether or not already being monitored for any or all of these parameters.
Exclusion criteria
* Any subject deemed too unstable, at the clinician's discretion, to participate in the study * Any subject with a cardiac anomaly that would cause a disparity between aortic pressures and the periphery. * Any subject who cannot tolerate, in the opinion of the clinician, multiple blood pressure measurements * Known disease state or medical condition that A) compromises circulation to the extremity (ies), B) compromises musculo-skeletal integrity, or C) otherwise contraindicates use of a NIBP cuff and/or SpO2 sensor on an extremity or ECG patches on skin * Excessive movement or excitability causing false values or no determinations (SP10 accuracy study only)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of one of the GE DINAMAP NIBP Monitor algorithms, SuperSTAT NIBP, in neonatal and/or infant subjects. | 1 year |
Countries
United States
Outcome results
None listed