Evaluation Of The GE Monitor Product Line

NCT00730119 — Withdrawn, GE Healthcare

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RegistryNCT00730119
StatusWithdrawn - Terminated due to lack of enrollment at target sites
Study typeObservational
SponsorGE Healthcare (Industry)
ConditionsNon-invasive Blood Pressure, Temperature, SpO2, Respiration, ECG
Datesstart 2001-10-01, primary completion 2010-03-01, completion 2010-05-01, first posted 2008-08-08, last updated 2017-08-08
Locations1 site in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Non-invasive Blood Pressure All trials for Temperature

-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) to itself, or one of the reference parameters, or a combination of parameters, including NIBP, temperature, SpO2, respirations, and ECG.

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+Arms and interventions

ArmTypeInterventionsDescription
NeonatesSubjects ages birth to 30 days
InfantsSubjects aged >30 days to 2 years
AdultsSubjects aged 18 years of age or older

+Outcome measures

Primary outcomes

  • 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. [unlimited]

+Eligibility

Sex: All, ages: 1 Minute to any, accepts healthy volunteers

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)

+Locations (1)

FacilityCityCountryStatus
GE HealthcareTampa, FloridaUnited States

+Investigators