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SuperSTAT 2.0 Noninvasive Blood Pressure Algorithm Enhancement (SNIPE)

This study has been terminated.
(The business decided not to pursue the study at this time.)
Information provided by (Responsible Party):
GE Healthcare Identifier:
First received: November 28, 2011
Last updated: August 8, 2016
Last verified: August 2016
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: Intervention Model: Single Group Assignment
Masking: None (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:
  • Data Collection for Engineering Development [ Time Frame: After each iteration of software development ]

    This was a data collection for engineering development to demonstrate SuperSTAT 2.0 NIBP software algorithm meets the engineering specifications. Engineers reviewed data produced by each blood pressure determination to work on new software algorithm in development. This was not conducted as program was terminated prematurely.

    Software iterations are not pre-defined.

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


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Results First Received: July 6, 2015
Last Updated: August 8, 2016 processed this record on August 18, 2017