This trial is active, not recruiting.

Condition non-invasive blood pressure
Treatment ge dinamap with superstat algorithm monitor
Sponsor GE Healthcare
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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective

Primary Outcomes

Evaluation of one of the GE DINAMAP NIBP Monitor algorithms, SuperSTAT NIBP, in neonatal and/or infant subjects.
time frame: 1 year

Eligibility Criteria

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)

Additional Information

Official title SuperSTAT Noninvasive Blood Pressure Monitor Evaluation
Principal investigator Laura Haubner, MD
Trial information was received from ClinicalTrials.gov and was last updated in July 2008.
Information provided to ClinicalTrials.gov by GE Healthcare.