Noninvasive Blood Pressure Monitor Evaluation Including Performance During Dysrhythmias

GE Healthcare1 site in 1 country40 target enrollmentApril 2007

ConditionsHealthy

Overview

Phase: N/A
Intervention: Not specified
Conditions: Healthy
Sponsor: GE Healthcare
Enrollment: 40
Locations: 1
Primary Endpoint: 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
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 2007

End Date

July 2007

Last Updated

3 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

GE Healthcare

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: 1-4 hours