SuperSTAT 2.0 Noninvasive Blood Pressure Algorithm Enhancement

Blood Pressure (Low, Normal, High) Clinical Trial

— SNIPE  

Official title:

SNIPE:SuperSTAT 2.0 Noninvasive Blood Pressure Algorithm Enhancement

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01482325
• Other study ID #: 118.02-2011-GES-0002
• Status: Terminated
• Phase: N/A
• First received: November 28, 2011
• Last updated: March 20, 2014
• Start date: November 2011
• Est. completion date: December 2013

Study information

• Verified date: March 2014
• Source: GE Healthcare
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to show that the noninvasive blood pressure software algorithm meets engineering requirements.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 31
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Blood Pressure (Low, Normal, High)

Intervention

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

Locations

Country	Name	City	State
United States	St. Josephs Hospital	Milwaukee	Wisconsin
United States	Wisconsin Heart Hospital	Wauwatosa	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
GE Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Engineering Specificiation	Demonstrate SuperSTAT 2.0 NIBP software algorithm meets the engineering specifications	After each iteration of software development	No