SpO2 System Accuracy Testing

This study is currently recruiting participants.
Verified June 2012 by GE Healthcare
Sponsor:
Information provided by (Responsible Party):
GE Healthcare
ClinicalTrials.gov Identifier:
NCT01613222
First received: June 5, 2012
Last updated: June 8, 2012
Last verified: June 2012
  Purpose

A 2 phase study to test the accuracy of SpO2 sensors with various patient monitors, co-oximeters, and modules.


Condition Intervention
Pulse Oximetry
Device: Pulse oximetry

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Official Title: SpO2 System Accuracy Testing

Further study details as provided by GE Healthcare:

Estimated Enrollment: 100
Study Start Date: June 2012
Arms Assigned Interventions
Experimental: Pulse oximetry monitoring Device: Pulse oximetry
Pulse oximetry measurement using SpO2 sensors, patient monitors, co-oximeters, and various modules.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Ability to provide written informed consent or have a legally authorized representative provide written informed consent
  • Subjects who are 18-45 years of age
  • Subjects must be willing and able to comply with study procedures
  • Subjects who are non-smokers or who have not smoked 2 days prior to consent.

Exclusion Criteria:

  • Subject or a legally authorized representative is unable to provide written inform consent.
  • Subjects that are considered morbidly obese (defined as BMI > 39.5),
  • Subjects with injuries, deformities or abnormalities that may prevent proper application of the device under test,
  • Smokers with COHb levels >3% or subjects who have smoked within two (2) days. Subjects will be screened for COHb levels of >3% with a Masimo Radical 7 (Rainbow).
  • Subjects with known respiratory conditions (uncontrolled asthma, head cold, flu, pneumonia / bronchitis, respiratory distress / respiratory or lung surgery, emphysema, COPD, lung disease),
  • Subjects with known heart or cardiovascular conditions,
  • Female subjects that are actively trying to get pregnant or are pregnant,
  • Subjects taking blood thinners or medications with aspirin or other antiplatelet medication in them (applies only to arterial draw study),
  • Subjects with Systolic blood pressure >140mmHg,
  • Subjects with Diastolic blood pressure >100mmHg,
  • Subjects with heart rhythms other than a normal sinus rhythm or with respiratory sinus arrhythmia
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01613222

Contacts
Contact: Jeffrey Conner, RN, BSN 414.477.8374 jeffrey.conner@ge.com

Locations
United States, Colorado
Clinimark Recruiting
Louisville, Colorado, United States, 80027
Contact: Paul Batchelder    303-717-4820    PBatchelder@Clinimark.com   
Principal Investigator: David Ransom, MD         
Sponsors and Collaborators
GE Healthcare
  More Information

No publications provided

Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT01613222     History of Changes
Other Study ID Numbers: 118.02-2011-GES-0012
Study First Received: June 5, 2012
Last Updated: June 8, 2012
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on April 17, 2014