SuperSTAT Noninvasive Blood Pressure Monitor Evaluation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00603486
Recruitment Status : Unknown
Verified July 2008 by GE Healthcare.
Recruitment status was:  Active, not recruiting
First Posted : January 29, 2008
Last Update Posted : July 23, 2008
Information provided by:
GE Healthcare

Brief Summary:
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.

Condition or disease Intervention/treatment
Non-Invasive Blood Pressure Device: GE DINAMAP with SuperSTAT algorithm monitor

Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: SuperSTAT Noninvasive Blood Pressure Monitor Evaluation
Study Start Date : November 2007
Actual Primary Completion Date : May 2008
Estimated Study Completion Date : July 2008

Intervention Details:
    Device: GE DINAMAP with SuperSTAT algorithm monitor
    Apply cuff on a limb, cuff is inflated and deflated, monitor will displays non-invasive blood pressure values (systolic, diastolic, MAP, and pulse rate)

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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Neonates in the NICU and newborn areas and/or infants.

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00603486

United States, Florida
GE Healthcare
Tampa, Florida, United States, 33614
Sponsors and Collaborators
GE Healthcare
Principal Investigator: Laura Haubner, MD University of South Florida

Responsible Party: Laura Haubner, MD, University of South Florida Identifier: NCT00603486     History of Changes
Other Study ID Numbers: CS 348
First Posted: January 29, 2008    Key Record Dates
Last Update Posted: July 23, 2008
Last Verified: July 2008

Keywords provided by GE Healthcare:
Non-invasive Blood Pressure (NIBP)
GE Dinamap