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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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 November 27, 2014