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SuperSTAT 2.0 Noninvasive Blood Pressure Algorithm Enhancement (SNIPE)

This study has suspended participant recruitment.
(Business decision to transfer engineers assigned to work on this study. Work will not be able to completed on this software for the next six months.)
Sponsor:
Information provided by (Responsible Party):
GE Healthcare
ClinicalTrials.gov Identifier:
NCT01482325
First received: November 28, 2011
Last updated: February 28, 2012
Last verified: February 2012
History of Changes
  Purpose

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


Estimated Enrollment: 150
Study Start Date: November 2011
Estimated Primary Completion Date: January 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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01482325

Locations
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

No publications provided

Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT01482325     History of Changes
Other Study ID Numbers: 118.02-2011-GES-0002
Study First Received: November 28, 2011
Last Updated: February 28, 2012
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on June 17, 2013