SuperSTAT 2.0 Noninvasive Blood Pressure Algorithm Enhanc... | NCT01482325

NCT01482325

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Oversight Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Subjects requiring blood pressure monitoring	Experimental	Any subject (neonate-adult) requiring hospital or clinic blood pressure monitoring	Device: Blood pressure monitoring with GE Healthcare DASH2500 Patient Monitor

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Blood pressure monitoring with GE Healthcare DASH2500 Patient Monitor	Device	10-20 Non-Invasive Blood Pressure readings on investigational software in the DASH2500 Patient Monitor

Outcomes Module

Primary Outcomes

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

Eligibility Module

Contacts/Locations Module

Facility	Status	City	State	ZIP	Country	Contacts
St. Josephs Hospital		Milwaukee	Wisconsin	53210	United States
Wisconsin Heart Hospital

Arm/Group Information

ID	Title	Description
FG000	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.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Subjects Requiring Blood Pressure Monitoring	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

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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.

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.

Posted

After each iteration of software development

ID	Title	Description
OG000	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.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Subjects Requiring Blood Pressure Monitoring	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 At Site #001 - St. Joseph's Hospital, there were 21 subjects screened, of which five were screen failures and 16 subjects completed the study. There were no adverse events reported. At Site #002 - Wisconsin Heart Hospital, there were 25 subjects screened, of which 10 were screen failures and 15 subjects completed the study. There were no adverse events reported.

Title	Organization	Phone	Extension	Email
Global Research Manager	GE Healthcare	414 721 2423		Jeffrey.Conner@ge.com

Intervention Browse Module

ID	Term
D019722	Sphygmomanometers
D019719	Diagnostic Equipment
D004864	Equipment and Supplies