Evaluation Of The GE Monitor Product Line

NCT00730119 | Withdrawn

• 1 other identifier: CS 327
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-invasive Blood Pressure; Temperature; SpO2; Respiration; ECG

Keywords

Non-invasive Blood Pressure (NIBP); GE Monitor; Temperature; SpO2; Respiration, ECG

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Neonates

Subjects ages birth to 30 days

Infants

Subjects aged \>30 days to 2 years

Adults

Subjects aged 18 years of age or older

Eligibility Criteria

• Age: 1 Minute+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All populations (neonatal, pediatrics, and adults).

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• GE Healthcare: lead

Study Sites (1)

GE Healthcare

Tampa, Florida, 33614, United States

Location

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jean D Sesing

  GE Healthcare

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2008
• First Posted: August 8, 2008
• Study Start: October 1, 2001
• Primary Completion: March 1, 2010
• Study Completion: May 1, 2010
• Last Updated: August 8, 2017

Record last verified: 2017-08

Locations

US (1)