SuperSTAT Noninvasive Blood Pressure Monitor Evaluation

Status unconfirmed

Conditions studied: Non-Invasive Blood Pressure

In brief

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.

Key facts

Study ID

NCT00603486

Run by

GE Healthcare

People needed

20

Starts

2007-11-01

Expected to finish

2008-07-01

Last updated by the study team

2008-07-23

Who can join

Age: any, up to 3. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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)

Where it is running

• GE Healthcare — Tampa, Florida, United States

Full record on ClinicalTrials.gov

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