Blood Pressure (Low, Normal, High)
Conditions
Brief summary
The primary objective of this study is to show that the noninvasive blood pressure software algorithm meets engineering requirements.
Interventions
DEVICEBlood pressure monitoring with GE Healthcare DASH2500 Patient Monitor
10-20 Non-Invasive Blood Pressure readings on investigational software in the DASH2500 Patient Monitor
Sponsors
GE Healthcare
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 31 |
| Total | 31 |
Baseline characteristics
| Characteristic | Subjects Requiring Blood Pressure Monitoring |
|---|---|
| Age, Continuous | 48.49 years STANDARD_DEVIATION 32.74 |
| Sex: Female, Male Female | 18 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 31 |
| serious Total, serious adverse events | 0 / 31 |
Outcome results
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.
Time frame: After each iteration of software development
Population: 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.