Noninvasive Blood Pressure Monitor Evaluation Including Performance During Dysrhythmias

Not Applicable

Completed

• Conditions: Healthy

• Registration Number: NCT00443001
• Lead Sponsor: GE Healthcare

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-03-02
• Study First Submitted QC: 2007-03-02
• Study First Posted: 2007-03-05
• Study Start: 2007-04
• Primary Completion: 2007-07
• Study Completion: 2007-07
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-25
• Last Update Posted: 2022-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

GE Healthcare; 🇺🇸 Milwaukee, Wisconsin, United States