Expired Study
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Tampa, Florida 33614


Purpose:

This investigation is a multi-center study that will demonstrate that the GE Monitor meets equivalency and/or accuracy and/or performance criteria. This investigation will compare the test device(s) to itself, or one of the reference parameters, or a combination of parameters, including NIBP, temperature, SpO2, respirations, and ECG.


Criteria:

Inclusion Criteria: - Signed informed consent from subject and/or guardian - Ability to maintain proper placement of cuff and/or probe and/or sensor - Presence of atrial fibrillation or other irregular heart rhythm (when applicable) - Ability to single or dual monitor NIBP, ECG, and/or SpO2, whether or not already being monitored for any or all of these parameters (SuperSTAT development study only) Exclusion Criteria: - Any subject deemed too unstable, by clinician's discretion, or for another reason deemed unacceptable for study by the clinician - Known dysrhythmias (when applicable) - Known disease state or medical condition that A) compromises circulation to the extremity, 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 - Vigorous exercise prior to participating in the study - Excessive movement or excitability causing false values or no determinations - Known allergy to latex when latex products will be in contact with subject - Subjects who have eaten, drank, smoked or chewed gum in the preceding half hour (temperature parameter only) - Nasal/septal defects, cold and/or allergies that would not allow the subject to breathe through their nose (temperature parameter only) - Subjects with whom flammable anesthetics will be used. - Adult/pediatric subjects,(greater than 1 year of age) who, at the clinician's discretion, could not tolerate approximately 12, but no more than 25 blood pressures on each extremity - Pediatric/neonatal subjects,(less than 1 year of age) who, at the clinician's discretion, could not tolerate approximately 10, but no more than 12 blood pressures on each extremity - Presence of pacemaker which makes the atrial fibrillation rhythm indistinguishable - Subject's limb circumference is outside of the manufacturer's recommended cuff range - Subject has Korotkoff sounds that persist to nearly zero (when applicable)


NCT ID:

NCT00730119


Primary Contact:

Study Director
Jean D Sesing
GE Healthcare


Backup Contact:

N/A


Location Contact:

Tampa, Florida 33614
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2018

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