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SpO2 System Accuracy Testing

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ClinicalTrials.gov Identifier: NCT01613222
Recruitment Status : Unknown
Verified June 2012 by GE Healthcare.
Recruitment status was:  Recruiting
First Posted : June 7, 2012
Last Update Posted : June 11, 2012
Sponsor:
Information provided by (Responsible Party):
GE Healthcare

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

Condition or disease Intervention/treatment
Pulse Oximetry Device: Pulse oximetry

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Official Title: SpO2 System Accuracy Testing
Study Start Date : June 2012

Arm Intervention/treatment
Experimental: Pulse oximetry monitoring Device: Pulse oximetry
Pulse oximetry measurement using SpO2 sensors, patient monitors, co-oximeters, and various modules.




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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT01613222     History of Changes
Other Study ID Numbers: 118.02-2011-GES-0012
First Posted: June 7, 2012    Key Record Dates
Last Update Posted: June 11, 2012
Last Verified: June 2012