Healthy
Conditions
Keywords
Non-Invasive Blood Pressure, Sinus Rhythm, Oscillometric, Invasive Blood Pressure, AAMI/ANSI SP10 Standard, Compliance with ANSI/AAMI SP10 2002 standard
Brief summary
This protocol focuses on the evaluation of the GE noninvasive blood pressure parameter in subjects with dysrhythmias and normal sinus rhythm. The study follows the recommendations of the ANSI/AAMI SP10 Standard.
Interventions
DEVICENon invasive blood pressure monitor
Updated device and software to improve performance in patients with dysrhythmia
Sponsors
GE Healthcare
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* signed informed consent * a patient who is undergoing a specialized procedure such as a surgical procedure or cardiac catheterization, or during critical care monitoring in which a central arterial catheter is in place to determine systolic, diastolic, and/or mean arterial blood pressure values. * ability to monitor ECG, NIBP and/or pulse oximetry * presence of atrial fibrillation, atrial flutter, or normal sinus rhythm
Exclusion criteria
* any subject deemed too unstable, at the clinician's discretion, to participate in the study * any subject with a cardiac or vascular malformation that results in an abnormal waveform inappropriate to be considered a reference standard * any subject with a cardiac anomaly that would cause a disparity between aortic pressures and the periphery. * presence of peripheral vascular disease in arms * inability to perform a minimum of 4 fast flushes (two at the study beginning and two at the study end) on an arterial catheter or line in order to determine a frequency response. The volume of fluid will not exceed a total pre-specified by the Principal Investigator or designee. * if the baseline arm to arm mean difference is \> 10 mmHg, then the differences will be recorded and evaluated by the Principal Investigator for possible subject exclusion from the data analysis. * subjects who, at the clinician's discretion, could not tolerate approximately 5 to 12, but possibly up to 25 repeated blood pressures on each arm
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of early systolic, systolic, and diastolic blood pressure, MAP and pulse rate as collected by an investigational non-invasive blood pressure device versus reference standards | 1-4 hours |
Countries
United States
Outcome results
None listed