Evaluation Of The GE Monitor Product Line

General Electric (GE)

Status

Withdrawn

Conditions

ECG

Respiration

Non-invasive Blood Pressure

SpO2

Temperature

Study type

Observational

Funder types

Industry

Identifiers

NCT00730119

CS 327

Details and patient eligibility

About

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.

Sex

All

Ages

1+ minute old

Volunteers

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)