SuperSTAT 2.0 Noninvasive Blood Pressure Algorithm Enhancement (SNIPE)

SNIPE:SuperSTAT 2.0 Noninvasive Blood Pressure Algorithm Enhancement

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

Study Overview

• Status: Terminated
• Conditions: Blood Pressure (Low, Normal, High)
• Intervention / Treatment: Device: Blood pressure monitoring with GE Healthcare DASH2500 Patient Monitor

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53210
      • St. Josephs Hospital
    • Wauwatosa, Wisconsin, United States, 53226
      • Wisconsin Heart Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Data Collection for Engineering 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.	After each iteration of software development

Collaborators and Investigators

• Sponsor: GE Healthcare

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: November 28, 2011
• First Submitted That Met QC Criteria: November 28, 2011
• First Posted (Estimate): November 30, 2011

Study Record Updates

• Last Update Posted (Estimate): September 30, 2016
• Last Update Submitted That Met QC Criteria: August 8, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 118.02-2011-GES-0002