SuperSTAT Noninvasive Blood Pressure Monitor Evaluation - Full Text View

Sponsored by:	GE Healthcare
Information provided by:	GE Healthcare
ClinicalTrials.gov Identifier:	NCT00603486

Purpose

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	Intervention
Non-Invasive Blood Pressure	Device: GE DINAMAP with SuperSTAT algorithm monitor

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Prospective
Official Title:	SuperSTAT Noninvasive Blood Pressure Monitor Evaluation

Further study details as provided by GE Healthcare:

Primary Outcome Measures:

Evaluation of one of the GE DINAMAP NIBP Monitor algorithms, SuperSTAT NIBP, in neonatal and/or infant subjects. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	20
Study Start Date:	November 2007
Estimated Study Completion Date:	July 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Intervention Details:

Apply cuff on a limb, cuff is inflated and deflated, monitor will displays non-invasive blood pressure values (systolic, diastolic, MAP, and pulse rate)

Eligibility

Ages Eligible for Study:	up to 3 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

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

Criteria

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00603486

Locations

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

Sponsors and Collaborators

GE Healthcare

Investigators

Principal Investigator:

Laura Haubner, MD

University of South Florida

More Information

Responsible Party:	University of South Florida ( Laura Haubner, MD )
Study ID Numbers:	CS 348
Study First Received:	January 7, 2008
Last Updated:	July 22, 2008
ClinicalTrials.gov Identifier:	NCT00603486
Health Authority:	United States: Institutional Review Board

Keywords provided by GE Healthcare:

Non-invasive Blood Pressure (NIBP)
GE Dinamap
SuperSTAT

ClinicalTrials.gov processed this record on January 14, 2009