ECG, Non-invasive Blood Pressure, Respiration, SpO2, Temperature
Conditions
Keywords
Non-invasive Blood Pressure (NIBP), GE Monitor, Temperature, SpO2, Respiration, ECG
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.
Interventions
None listed
Sponsors
GE Healthcare
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Minutes to No maximum
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed