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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
History of Changes
  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.


Condition Intervention
Non-invasive Blood Pressure
Temperature
SpO2
Respiration
ECG
 Device: Measuring vital signs using the GE Monitor

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluation Of The GE Monitor Product Line

Further study details as provided by GE Healthcare:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 1500
Study Start Date: October 2001
Study Completion Date: May 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
N
Neonates
 Device: Measuring vital signs using the GE Monitor
Measuring vital signs (NIBP, SpO2, Temperature, Respiration, and ECG)
I
Infants
 Device: Measuring vital signs using the GE Monitor
Measuring vital signs (NIBP, SpO2, Temperature, Respiration, and ECG)
A
Adults
 Device: Measuring vital signs using the GE Monitor
Measuring vital signs (NIBP, SpO2, Temperature, Respiration, and ECG)

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

All populations (neonatal, pediatrics, and adults).

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00730119

Locations
United States, Florida
GE Healthcare
Tampa, Florida, United States, 33614
Sponsors and Collaborators
GE Healthcare
Investigators
Study Director: Jean D Sesing GE Healthcare
  More Information

No publications provided

Responsible Party: Andrea D. Stebor, ARNP, PhD, Clinical Research Manager, GE Healthcare
ClinicalTrials.gov Identifier: NCT00730119     History of Changes
Other Study ID Numbers: CS 327
Study First Received: August 5, 2008
Last Updated: April 2, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by GE Healthcare:
Non-invasive Blood Pressure (NIBP)
GE Monitor
Temperature
SpO2
Respiration, ECG

ClinicalTrials.gov processed this record on May 22, 2013