Evaluation Of The GE Monitor Product Line

Withdrawn

• Conditions: Respiration; ECG; Temperature; SpO2; Non-invasive Blood Pressure

• Registration Number: NCT00730119
• Lead Sponsor: GE Healthcare

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-10
• Study First Submitted: 2008-08-05
• Study First Submitted QC: 2008-08-05
• Study First Posted: 2008-08-08
• Primary Completion: 2010-03
• Study Completion: 2010-05
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-07
• Last Update Posted: 2017-08-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

GE Healthcare; 🇺🇸 Tampa, Florida, United States