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Evaluation Of The GE Monitor Product Line

This study has been completed.
Sponsor:
Information provided by:
GE Healthcare
ClinicalTrials.gov Identifier:
NCT00730119
First received: August 5, 2008
Last updated: April 2, 2012
Last verified: April 2012

August 5, 2008
April 2, 2012
October 2001
March 2010   (final data collection date for primary outcome measure)
This investigation will compare values from the test device(s) to itself, or one of the reference parameters, or a combination of parameters, including NIBP, temperature, SpO2, respirations, and ECG. [ Time Frame: unlimited ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00730119 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Evaluation Of The GE Monitor Product Line
Evaluation Of The GE Monitor Product Line

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.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

All populations (neonatal, pediatrics, and adults).

  • Non-invasive Blood Pressure
  • Temperature
  • SpO2
  • Respiration
  • ECG
Device: Measuring vital signs using the GE Monitor
Measuring vital signs (NIBP, SpO2, Temperature, Respiration, and ECG)
  • N
    Neonates
    Intervention: Device: Measuring vital signs using the GE Monitor
  • I
    Infants
    Intervention: Device: Measuring vital signs using the GE Monitor
  • A
    Adults
    Intervention: Device: Measuring vital signs using the GE Monitor
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1500
May 2010
March 2010   (final data collection date for primary outcome measure)

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)
Both
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00730119
CS 327
No
Andrea D. Stebor, ARNP, PhD, Clinical Research Manager, GE Healthcare
GE Healthcare
Not Provided
Study Director: Jean D Sesing GE Healthcare
GE Healthcare
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP