SpO2 System Accuracy Testing With Different Sensors
Completed · Not applicable
Conditions studied: Pulse Oximetry
In brief
A study to test the accuracy of SpO2 sensors with various patient monitors, co-oximeters, and modules.
Key facts
- Study ID
- NCT01613222
- Run by
- GE Healthcare
- People needed
- 63
- Starts
- 2012-06-19
- Expected to finish
- 2013-02-15
- Last updated by the study team
- 2019-02-05
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- Clinimark — Louisville, Colorado, United States
Full record on ClinicalTrials.gov
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