Noninvasive Blood Pressure Monitor Evaluation Including Performance During Dysrhythmias
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2008 by GE Healthcare.
Recruitment status was Recruiting
Information provided by:
First received: March 2, 2007
Last updated: July 23, 2008
Last verified: July 2008
This protocol focuses on the evaluation of the GE noninvasive blood pressure parameter in subjects with dysrhythmias and normal sinus rhythm. The study follows the recommendations of the ANSI/AAMI SP10 Standard.
Device: Non invasive blood pressure monitor
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Diagnostic
||Noninvasive Blood Pressure Monitor Evaluation Including Performance During Dysrhythmias
Primary Outcome Measures:
- Comparison of early systolic, systolic, and diastolic blood pressure, MAP and pulse rate as collected by an investigational non-invasive blood pressure device versus reference standards [ Time Frame: 1-4 hours ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 2009 (Final data collection date for primary outcome measure)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- signed informed consent
- a patient who is undergoing a specialized procedure such as a surgical procedure or cardiac catheterization, or during critical care monitoring in which a central arterial catheter is in place to determine systolic, diastolic, and/or mean arterial blood pressure values.
- ability to monitor ECG, NIBP and/or pulse oximetry
- presence of atrial fibrillation, atrial flutter, or normal sinus rhythm
- any subject deemed too unstable, at the clinician's discretion, to participate in the study
- any subject with a cardiac or vascular malformation that results in an abnormal waveform inappropriate to be considered a reference standard
- any subject with a cardiac anomaly that would cause a disparity between aortic pressures and the periphery.
- presence of peripheral vascular disease in arms
- inability to perform a minimum of 4 fast flushes (two at the study beginning and two at the study end) on an arterial catheter or line in order to determine a frequency response. The volume of fluid will not exceed a total pre-specified by the Principal Investigator or designee.
- if the baseline arm to arm mean difference is > 10 mmHg, then the differences will be recorded and evaluated by the Principal Investigator for possible subject exclusion from the data analysis.
- subjects who, at the clinician's discretion, could not tolerate approximately 5 to 12, but possibly up to 25 repeated blood pressures on each arm
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00443001
|Contact: Diego Lozano
|Contact: Andrea Stebor
|Tampa, Florida, United States, 33614 |
|Contact: Diego Lozano (813) 887-2055 |
||Russel Hirsch, MD
||Cardiac Catheterization Laboratory Division of Cardiology
No publications provided
||Andrea Stebor, GE Healthcare
History of Changes
|Other Study ID Numbers:
|Study First Received:
||March 2, 2007
||July 23, 2008
||United States: Institutional Review Board
Keywords provided by GE Healthcare:
ClinicalTrials.gov processed this record on August 27, 2015
Non-Invasive Blood Pressure
Invasive Blood Pressure
AAMI/ANSI SP10 Standard
Compliance with ANSI/AAMI SP10 2002 standard