We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01482325
First Posted: November 30, 2011
Last Update Posted: September 30, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GE Healthcare
  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: 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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT01482325     History of Changes
Other Study ID Numbers: 118.02-2011-GES-0002
First Submitted: November 28, 2011
First Posted: November 30, 2011
Results First Submitted: July 6, 2015
Results First Posted: September 30, 2016
Last Update Posted: September 30, 2016
Last Verified: August 2016