An interventional study of Vital Signs Patch (VSP) in Desaturation of Blood, sponsored by LifeWatch Services, Inc.. Completed at 1 site in United States. Open to participants aged 23 Years to 33 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-08-28.
Sponsored by LifeWatch Services, Inc. (part of Philips) · Not applicable, Interventional, and Supportive care
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.
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.
LifeWatch Services, Inc. is the lead sponsor of 5 studies on the registry; none are open to participants now.
First submitted before LifeWatch Services, Inc. became part of Philips.
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Exclusion Criteria:
Infrared and Red absorbance measurement on chest
Device: Vital Signs Patch (VSP)
Infrared and red absorbance measurement
Also known as: Vital signs Patch, VSP
Composite Outcome Measure: Successful Capture of Peripheral Capillary Oxygen Saturation (SpO2) Level
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.
Time frame: within 24 hrs
| Milestone | Vital Signs Patch (VSP) |
|---|---|
| Started | 12 |
| Completed | 12 |
| Not completed | 0 |
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.
| participants | Vital Signs Patch (VSP) |
|---|---|
| Composite Outcome Measure: Successful Capture of Peripheral Capillary Oxygen Saturation (SpO2) Level | 12 |
Collected over Adverse event collection was limited to the duration of the study for each participant, which was 24 hours.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Vital Signs Patch (VSP) | — | 0/12 (0%) | 0/12 (0%) |
| Age, Categorical(Participants) | Vital Signs Patch (VSP) |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 12 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Vital Signs Patch (VSP) |
|---|---|
| Female | 7 |
| Male | 5 |
| Ethnicity (NIH/OMB)(Participants) | Vital Signs Patch (VSP) |
|---|---|
| Hispanic or Latino | 2 |
| Not Hispanic or Latino | 10 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Vital Signs Patch (VSP) |
|---|---|
| United States | 12 |
The record gives a start of Mar 2013, a primary completion of Mar 2013 and a completion of Mar 2013. It does not say whether these dates are actual or estimated.
Results were first posted in Aug 2015, 2 years 5 months after primary completion.
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This study is completed, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.
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