SuperSTAT Noninvasive Blood Pressure Monitor Evaluation

The accuracy and/or performance of the GE DINAMAP noninvasive blood pressure (NIBP) monitors may be improved with modifications in software and/or hardware monitoring techniques and/or accessories. When changes are being made to the GE Monitor, testing can be done to evaluate performance of the investigational devices during and/or after product development.

Study Overview

• Status: Unknown
• Conditions: Non-Invasive Blood Pressure
• Intervention / Treatment: Device: GE DINAMAP with SuperSTAT algorithm monitor

• Study Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33614
      • GE Healthcare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 3 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Neonates in the NICU and newborn areas and/or infants.

Description

Inclusion criteria

• Signed informed consent
• Ability to single or dual monitor NIBP, ECG, and/or SpO2, whether or not already being monitored for any or all of these parameters.

Exclusion Criteria

• Any subject deemed too unstable, at the clinician's discretion, to participate in the study
• Any subject with a cardiac anomaly that would cause a disparity between aortic pressures and the periphery.
• Any subject who cannot tolerate, in the opinion of the clinician, multiple blood pressure measurements
• Known disease state or medical condition that A) compromises circulation to the extremity (ies), B) compromises musculo-skeletal integrity, or C) otherwise contraindicates use of a NIBP cuff and/or SpO2 sensor on an extremity or ECG patches on skin
• Excessive movement or excitability causing false values or no determinations (SP10 accuracy study only)

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Evaluation of one of the GE DINAMAP NIBP Monitor algorithms, SuperSTAT NIBP, in neonatal and/or infant subjects.	1 year

Collaborators and Investigators

• Sponsor: GE Healthcare
• Investigators: Principal Investigator: Laura Haubner, MD, University Of South Florida

Study record dates

Study Major Dates

• Study Start: November 1, 2007
• Primary Completion (Actual): May 1, 2008
• Study Completion (Anticipated): July 1, 2008

Study Registration Dates

• First Submitted: January 7, 2008
• First Submitted That Met QC Criteria: January 16, 2008
• First Posted (Estimate): January 29, 2008

Study Record Updates

• Last Update Posted (Estimate): July 23, 2008
• Last Update Submitted That Met QC Criteria: July 22, 2008
• Last Verified: July 1, 2008

More Information

Terms related to this study

• Keywords: Non-invasive Blood Pressure (NIBP); GE Dinamap; SuperSTAT
• Other Study ID Numbers: CS 348