SuperSTAT 2.0 Noninvasive Blood Pressure Algorithm Enhancement
Not Applicable
Terminated
- Conditions
- Blood Pressure (Low, Normal, High)
- Interventions
- Device: Blood pressure monitoring with GE Healthcare DASH2500 Patient Monitor
- Registration Number
- NCT01482325
- Lead Sponsor
- GE Healthcare
- Brief Summary
The primary objective of this study is to show that the noninvasive blood pressure software algorithm meets engineering requirements.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 31
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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Subjects requiring blood pressure monitoring Blood pressure monitoring with GE Healthcare DASH2500 Patient Monitor Any subject (neonate-adult) requiring hospital or clinic blood pressure monitoring
- Primary Outcome Measures
Name Time Method Data Collection for Engineering Development 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
St. Josephs Hospital
🇺🇸Milwaukee, Wisconsin, United States
Wisconsin Heart Hospital
🇺🇸Wauwatosa, Wisconsin, United States