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SpO2 System Accuracy Testing

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2012 by GE Healthcare.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
GE Healthcare Identifier:
First received: June 5, 2012
Last updated: June 8, 2012
Last verified: June 2012
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
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.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
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Please refer to this study by its identifier: NCT01613222

Contact: Jeffrey Conner, RN, BSN 414.477.8374

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

Responsible Party: GE Healthcare 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 processed this record on April 28, 2017