Evaluation Of The GE Monitor Product Line

Respiration Clinical Trial

Official title:

Evaluation Of The GE Monitor Product Line

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00730119
• Other study ID #: CS 327
• Status: Withdrawn
• Phase: N/A
• First received: August 5, 2008
• Last updated: August 7, 2017
• Start date: October 2001
• Est. completion date: May 2010

Study information

• Verified date: August 2017
• Source: GE Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
United States	GE Healthcare	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
GE Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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