Noninvasive Blood Pressure Monitor Evaluation Including Performance During Dysrhythmias

July 25, 2022 updated by: GE Healthcare

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.

Study Overview

Status

Completed

Conditions

Healthy

Intervention / Treatment

Device: Non invasive blood pressure monitor

Study Type

Interventional

Enrollment (Anticipated)

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Wisconsin
  - Milwaukee, Wisconsin, United States, 53223
    - GE Healthcare

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult
Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Interventional Model: Crossover Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome 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 Time Frame: 1-4 hours	1-4 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GE Healthcare

Investigators

Study Director: Russel Hirsch, MD, Cardiac Catheterization Laboratory Division of Cardiology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Actual)

July 1, 2007

Study Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

March 2, 2007

First Submitted That Met QC Criteria