SuperSTAT 2.0 Noninvasive Blood Pressure Algorithm Enhancement (SNIPE)

This study has been terminated.
Information provided by (Responsible Party):
GE Healthcare Identifier:
First received: November 28, 2011
Last updated: March 20, 2014
Last verified: March 2014
The primary objective of this study is to show that the noninvasive blood pressure software algorithm meets engineering requirements.

Condition Intervention
Blood Pressure (Low, Normal, High)
Device: Blood pressure monitoring with GE Healthcare DASH2500 Patient Monitor

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: SNIPE:SuperSTAT 2.0 Noninvasive Blood Pressure Algorithm Enhancement

Further study details as provided by GE Healthcare:

Primary Outcome Measures:
  • Engineering Specificiation [ Time Frame: After each iteration of software development ] [ Designated as safety issue: No ]
    Demonstrate SuperSTAT 2.0 NIBP software algorithm meets the engineering specifications

Enrollment: 31
Study Start Date: November 2011
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Subjects requiring blood pressure monitoring
Any subject (neonate-adult) requiring hospital or clinic blood pressure monitoring
Device: Blood pressure monitoring with GE Healthcare DASH2500 Patient Monitor
10-20 Non-Invasive Blood Pressure readings on investigational software in the DASH2500 Patient Monitor


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Ability to provide written informed consent or have a legally authorized representative including a parent or guardian provide written informed consent
  • Ability of a minor subject ages 7 to 18 to provide written assent
  • Ability to have multiple noninvasive blood pressures taken at one sitting
  • Ability to apply three lead ECG, if needed for investigation
  • Ability to detect the natural presence of an irregular pulse, for irregular pulse studies

Exclusion Criteria:

  • Any subject who cannot tolerate multiple blood pressure measurements
  • Any subject who cannot undergo 3-lead ECG, if needed
  • Any subject deemed unstable by the principal investigator
  • Any subject for whom precautions are necessary because of communicable disease
  • Any subject that has a known disease or condition compromises musculoskeletal integrity
  • Any subject that has a known disease or condition that contraindicates use of an NIBP cuff and ECG patches on the skin.
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Please refer to this study by its identifier: NCT01482325

United States, Wisconsin
St. Josephs Hospital
Milwaukee, Wisconsin, United States, 53210
Wisconsin Heart Hospital
Wauwatosa, Wisconsin, United States, 53226
Sponsors and Collaborators
GE Healthcare
  More Information

Responsible Party: GE Healthcare Identifier: NCT01482325     History of Changes
Other Study ID Numbers: 118.02-2011-GES-0002 
Study First Received: November 28, 2011
Last Updated: March 20, 2014
Health Authority: United States: Food and Drug Administration processed this record on May 30, 2016