Noninvasive Blood Pressure Monitor Evaluation Including Performance During Dysrhythmias

NCT ID: NCT00443001

Last Updated: 2022-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-04-30
• Study Completion Date: 2007-07-31

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.

Conditions

Healthy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Interventions

Non invasive blood pressure monitor

Updated device and software to improve performance in patients with dysrhythmia

Intervention Type: DEVICE

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GE Healthcare

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Russel Hirsch, MD

Role: STUDY_DIRECTOR

Cardiac Catheterization Laboratory Division of Cardiology

Locations

GE Healthcare

Milwaukee, Wisconsin, United States

Countries

United States

Other Identifiers

CS 347

Identifier Type: -

Identifier Source: org_study_id