Evaluation Of The GE Monitor Product Line

August 7, 2017 updated by: GE Healthcare

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.

Study Overview

Status

Withdrawn

Conditions

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Florida
  - Tampa, Florida, United States, 33614
    - GE Healthcare

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 minute and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All populations (neonatal, pediatrics, and adults).

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
Neonates Subjects ages birth to 30 days
Infants Subjects aged >30 days to 2 years
Adults Subjects aged 18 years of age or older

What is the study measuring?

Primary Outcome Measures

Outcome 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. Time Frame: unlimited	unlimited

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GE Healthcare

Investigators

Study Director: Jean D Sesing, GE Healthcare

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2001

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

August 5, 2008

First Submitted That Met QC Criteria