Status:
WITHDRAWN
Evaluation Of The GE Monitor Product Line
Lead Sponsor:
GE Healthcare
Conditions:
Non-invasive Blood Pressure
Temperature
Eligibility:
All Genders
1+ years
Brief Summary
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) t...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
October 1 2001
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00730119
Start Date
October 1 2001
End Date
May 1 2010
Last Update
August 8 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
GE Healthcare
Tampa, Florida, United States, 33614