SuperSTAT Noninvasive Blood Pressure Monitor Evaluation

General Electric (GE)

Status: Unknown

Conditions: Non-Invasive Blood Pressure

Treatments: Device: GE DINAMAP with SuperSTAT algorithm monitor

Study type: Observational

Funder types: Industry

Identifiers

NCT00603486

CS 348

Details and patient eligibility

About

The accuracy and/or performance of the GE DINAMAP noninvasive blood pressure (NIBP) monitors may be improved with modifications in software and/or hardware monitoring techniques and/or accessories. When changes are being made to the GE Monitor, testing can be done to evaluate performance of the investigational devices during and/or after product development.

Enrollment: 20 estimated patients

Sex: All

Ages: Under 3 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

• Signed informed consent
• Ability to single or dual monitor NIBP, ECG, and/or SpO2, whether or not already being monitored for any or all of these parameters.

Exclusion Criteria

• Any subject deemed too unstable, at the clinician's discretion, to participate in the study
• Any subject with a cardiac anomaly that would cause a disparity between aortic pressures and the periphery.
• Any subject who cannot tolerate, in the opinion of the clinician, multiple blood pressure measurements
• Known disease state or medical condition that A) compromises circulation to the extremity (ies), B) compromises musculo-skeletal integrity, or C) otherwise contraindicates use of a NIBP cuff and/or SpO2 sensor on an extremity or ECG patches on skin
• Excessive movement or excitability causing false values or no determinations (SP10 accuracy study only)