Noninvasive Blood Pressure Monitor Evaluation Including Performance During Dysrhythmias

General Electric (GE)

Status

Completed

Conditions

Healthy

Treatments

Device: Non invasive blood pressure monitor

Study type

Interventional

Funder types

Industry

Identifiers

NCT00443001

CS 347

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Volunteers

Accepts Healthy Volunteers

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