Pulse Oximeter Response TO Multiple Levels Of Stable Hypoxia
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Desaturation of Blood
- Sponsor
- LifeWatch Services, Inc.
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Composite Outcome Measure: Successful Capture of Peripheral Capillary Oxygen Saturation (SpO2) Level
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
A clinical study designed to determine the accuracy of the peripheral capillary oxygen saturation (SpO2) function of the Vital Signs Patch (VSP) device for measuring blood saturation level.
Detailed Description
The clinical study protocol was designed for determining the accuracy of the SpO2 function of the Vital Signs Patch device for measuring blood oxygen saturation level, according to the guidelines for "evaluating and documenting SpO2 accuracy in human subjects" as set out in Annex EE of ISO 80601-2-61. Section 4.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Ages 23 to
- •Skin tone varied from light to dark.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Composite Outcome Measure: Successful Capture of Peripheral Capillary Oxygen Saturation (SpO2) Level
Time Frame: within 24 hrs
Successful capture of SpO2 levels - Infrared and red light absorbency was measured and used for SpO2 percentage calculation from both the Vital Signs Patch (VSP) study device and an invasive Blood Arterial Hemoximeter (standard method) to determine the level of accuracy of data obtained from the VSP device when compared data taken from the Arterial Hemoximeter. A comparison was made by calculating the Average Root Mean Square (Arms) and comparing against the Arms error rate limit of less than or equal to 3.5% at a 95% confidence level. The outcome is either positive or negative - this is a composite outcome measure.