Accuracy of Pulse Oximeters With Profound Hypoxia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02571686|
Recruitment Status : Completed
First Posted : October 8, 2015
Last Update Posted : December 24, 2015
|Condition or disease||Intervention/treatment|
|Oximetry, Pulse||Device: Surveyor S4|
Studies normally involve 6-12 normal adult volunteer paid subjects, with 20-25 1-2 ml arterial blood samples from each subject obtained at different steady-state levels of hypoxia from 70-100%. Blood samples obtained from an arterial line are measured in a hemoximeter to determine true saturation value. Some sponsors may not require any blood sampling. Some sponsors may require additional blood samples, up to 35 samples may be drawn.
Readings from the test pulse oximeters are recorded and compared to these "gold-standard" blood values. The pulse oximeter probes may be located at a variety of sites on the subjects, including fingers, toes, ears, forehead, scalp and bridge of the nose. These detector-probes are all non-invasive. The level of hypoxia is measured and controlled by the investigator. A computer program that displays a prediction, breath by breath, the arterial oxygen saturation, (SaO2) of the study subject. SaO2 is computed from end-expired Po2 and Pco2 as determined by mass spectrometer gas analysis. This information permits the inspired gas mixture of air, plus CO2 and nitrogen, to be adjusted by an operator watching the value computed after each expiration on an analog meter. This computer-estimated saturation is adjusted by the operator to one of 6 levels of predicted saturation, and is held stable for about 30 seconds at each level. Two or three "runs" are conducted per subject. Each "run" lasts 8-12 min and 4 to 5 plateaus are tested per run. The manufacturer may choose the target values. Plateaus are typically sought at 92%, 86%, 80%, 74%, 68% and 62%. Other manufacturers have asked for an equal number of data points but with all points between 70% and 100%. Some sponsors may also request additional variables to be measured during testing including high or low Carbon Dioxide (CO2), where subjects will be asked to hyperventilate; low perfusion, where subjects will be asked to lay flat, or with their head up or down; testing pulse oximeters during motion, with the subject's hand fixed to a motion machine; or measure eye-tracking during hypoxia. The subject's will be informed by the study staff and in the consent form if any of these additional procedures apply.
|Study Type :||Observational|
|Actual Enrollment :||10 participants|
|Official Title:||Accuracy of Pulse Oximeters With Profound Hypoxia|
|Study Start Date :||October 2015|
|Actual Primary Completion Date :||October 2015|
|Actual Study Completion Date :||October 2015|
- Accuracy of Pulse Oximeter [ Time Frame: 2 months ]
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): NCT02571686
|United States, California|
|Department of Anesthesia Clinical Studies Facility, room A-65 Parnassus Campus.|
|San Francisco, California, United States, 94143|