Noninvasive Blood Pressure Monitor Evaluation Including Performance During Dysrhythmias

NCT00443001 | Completed DMC

• 1 other identifier: CS 347
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

Non-Invasive Blood Pressure; Sinus Rhythm; Oscillometric; Invasive Blood Pressure; AAMI/ANSI SP10 Standard; Compliance with ANSI/AAMI SP10 2002 standard

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Non invasive blood pressure monitor DEVICE

Updated device and software to improve performance in patients with dysrhythmia

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• GE Healthcare: lead

Study Sites (1)

GE Healthcare

Milwaukee, Wisconsin, 53223, United States

Location

Study Officials

• Russel Hirsch, MD

  Cardiac Catheterization Laboratory Division of Cardiology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2007
• First Posted: March 5, 2007
• Study Start: April 1, 2007
• Primary Completion: July 1, 2007
• Study Completion: July 1, 2007
• Last Updated: July 27, 2022

Record last verified: 2022-07

Locations

US (1)