Clinical trial NCT00730119: Evaluation Of The GE Monitor Product Line
Official title: Evaluation Of The GE Monitor Product Line
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Non-invasive Blood Pressure
Temperature
SpO2
Respiration
ECG
Keywords: Non-invasive Blood Pressure (NIBP)
GE Monitor
Temperature
SpO2
Respiration, ECG
Lead sponsor: GE Healthcare
Sponsor class: INDUSTRY
First posted: 2008-08-08
Enrollment: 0
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All populations (neonatal, pediatrics, and adults).

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


Eligibility 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)

Primary outcomes:
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.
timeFrame: unlimited
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: GE Healthcare
state: Florida
Study officials:
affiliation: GE Healthcare
name: Jean D Sesing
role: STUDY_DIRECTOR
References: