Trial Outcomes & Findings for SuperSTAT 2.0 Noninvasive Blood Pressure Algorithm Enhancement (NCT NCT01482325)
NCT ID: NCT01482325
Last Updated: 2016-09-30
Results Overview
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.
TERMINATED
NA
31 participants
After each iteration of software development
2016-09-30
Participant Flow
Participant milestones
| Measure |
Subjects Requiring Blood Pressure Monitoring
St. Joseph's Hospital (001), there were 21 subjects screened, of which five were screen failures and 16 subjects completed the study. Wisconsin Heart Hospital (002), there were 25 subjects screened, of which 10 were screen failures and 15 subjects completed the study.
There were enrollment criteria followed by both Site 001 and Site 002 that were provided by the study's GEHC engineer in order to test the SuperSTAT algorithm. Each set of subjects enrolled under the required enrollment criteria were tested by the GEHC engineer.
|
|---|---|
|
Overall Study
STARTED
|
31
|
|
Overall Study
COMPLETED
|
31
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
SuperSTAT 2.0 Noninvasive Blood Pressure Algorithm Enhancement
Baseline characteristics by cohort
| Measure |
Subjects Requiring Blood Pressure Monitoring
n=31 Participants
Any subject (neonate-adult) requiring hospital or clinic blood pressure monitoring
Blood pressure monitoring with GE Healthcare DASH2500 Patient Monitor: 10-20 Non-Invasive Blood Pressure readings on investigational software in the DASH2500 Patient Monitor
|
|---|---|
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Age, Continuous
|
48.49 years
STANDARD_DEVIATION 32.74 • n=5 Participants
|
|
Sex: Female, Male
Female
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18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: After each iteration of software developmentPopulation: Subject analysis was not performed because study was prematurely terminated. Work on the project ceased when it was terminated.The study was intended to have the engineers review data produced by each blood pressure determination to work on new software algorithm in development. This was not and will not be conducted.
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.
Outcome measures
Outcome data not reported
Adverse Events
Subjects Requiring Blood Pressure Monitoring
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place