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SpO2 System Accuracy Testing With Different Sensors

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ClinicalTrials.gov Identifier: NCT01613222
Recruitment Status : Completed
First Posted : June 7, 2012
Results First Posted : February 5, 2019
Last Update Posted : February 5, 2019
Sponsor:
Information provided by (Responsible Party):
GE Healthcare

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

Condition or disease Intervention/treatment Phase
Pulse Oximetry Device: Pulse oximetry Not Applicable

Detailed Description:
The U-TruSignal with different sensors is feasible for noninvasive and continuous SpO2 monitoring and meets the specified measurement accuracy when compared to a co-oximetry gold reference.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: SpO2 System Accuracy Testing
Actual Study Start Date : June 19, 2012
Actual Primary Completion Date : February 15, 2013
Actual Study Completion Date : February 15, 2013

Arm Intervention/treatment
Experimental: Pulse oximetry monitoring
The U-TruSignal with different sensors is feasible for noninvasive and continuous SpO2 monitoring and meets the specified measurement accuracy when compared to a co-oximetry gold reference.
Device: Pulse oximetry
Pulse oximetry measurement using SpO2 sensors, patient monitors, co-oximeters, and various modules.




Primary Outcome Measures :
  1. Accuracy Root Mean Square (ARMS) [ Time Frame: 60 minutes ]
    The Accuracy Root Mean Square (ARMS) calculation is used to measure accuracy of the test SpO2 device compared to reference SpO2 device. A scatterplot is created with the forehead sensor saturation on the y-axis and the measured blood saturation on the x-axis. The line of identity is drawn representing the ideal points, meaning that the forehead sensor saturation is always the same as the blood saturation. The dispersion of the actual data points around the line of identity can be measured using a statistical calculation called Arithmetic Root Mean Square (ARMS). The smaller ARMs the closer the data points lie around the line of identity, representing a more accurate sensor as accurate and appropriate. Data analysis follows ISO 80601-2-61, 2011, Annex EE and the FDA Guidance Document for Pulse Oximeters (FDA Draft Guidance, July 19, 2007).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 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 18-55 years of age
  • Subjects must be willing and able to comply with study procedures
  • HbCO<3% (for smokers only)

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


Locations
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United States, Colorado
Clinimark
Louisville, Colorado, United States, 80027
Sponsors and Collaborators
GE Healthcare
Investigators
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Study Director: Jeffrey Conner GEHC

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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
Results First Posted: February 5, 2019
Last Update Posted: February 5, 2019
Last Verified: January 2019