Trial Outcomes & Findings for Clinical Study of Peripheral Capillary Oxygen Saturation (SpO2): Vital Signs Patch (VSP) (NCT NCT01899911)
NCT ID: NCT01899911
Last Updated: 2015-08-28
Results Overview
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.
COMPLETED
NA
12 participants
within 24 hrs
2015-08-28
Participant Flow
Participant milestones
| Measure |
Vital Signs Patch (VSP)
Infrared and Red absorbance measurement on chest
VSP: Infrared and red absorbance measurement
|
|---|---|
|
Overall Study
STARTED
|
12
|
|
Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Study of Peripheral Capillary Oxygen Saturation (SpO2): Vital Signs Patch (VSP)
Baseline characteristics by cohort
| Measure |
Vital Signs Patch (VSP)
n=12 Participants
Infrared and Red absorbance measurement on chest
VSP: Infrared and red absorbance measurement
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: within 24 hrsPopulation: Peripheral capillary oxygen saturation (SpO2) Measurements Taken on the 12 Participants
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.
Outcome measures
| Measure |
Vital Signs Patch (VSP)
n=12 Participants
Infrared and Red absorbance measurement on chest
|
|---|---|
|
Composite Outcome Measure: Successful Capture of Peripheral Capillary Oxygen Saturation (SpO2) Level
|
12 participants
|
Adverse Events
Vital Signs Patch (VSP)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Philip E. Bickler, MD, PhD, Professor of Anesthesia
University of California, San Francisco (UCSF)
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60