SuperSTAT Noninvasive Blood Pressure Monitor Evaluation
This trial is active, not recruiting.
|Condition||non-invasive blood pressure|
|Treatment||ge dinamap with superstat algorithm monitor|
|Start date||November 2007|
|End date||May 2008|
|Trial size||20 participants|
|Trial identifier||NCT00603486, CS 348|
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.
Evaluation of one of the GE DINAMAP NIBP Monitor algorithms, SuperSTAT NIBP, in neonatal and/or infant subjects.
time frame: 1 year
Male or female participants up to 3 years old.
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)
|Official title||SuperSTAT Noninvasive Blood Pressure Monitor Evaluation|
|Principal investigator||Laura Haubner, MD|
Call for more information