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SuperSTAT Noninvasive Blood Pressure Monitor Evaluation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2008 by GE Healthcare.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
GE Healthcare
ClinicalTrials.gov Identifier:
NCT00603486
First received: January 7, 2008
Last updated: July 22, 2008
Last verified: July 2008
History of Changes

January 7, 2008
July 22, 2008
November 2007
May 2008   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00603486 on ClinicalTrials.gov Archive Site
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SuperSTAT Noninvasive Blood Pressure Monitor Evaluation
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.
Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

Neonates in the NICU and newborn areas and/or infants.
Non-Invasive Blood Pressure
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)
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Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
20
July 2008
May 2008   (final data collection date for primary outcome measure)

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)
Both
up to 3 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00603486
CS 348
No
Laura Haubner, MD, University of South Florida
GE Healthcare
Not Provided
Principal Investigator: Laura Haubner, MD University of South Florida
GE Healthcare
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP