Clinical Study of Peripheral Capillary Oxygen Saturation (SpO2): Vital Signs Patch (VSP)
Pulse Oximeter Response TO Multiple Levels Of Stable Hypoxia
1 other identifier
interventional
12
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedFirst Submitted
Initial submission to the registry
July 7, 2013
CompletedFirst Posted
Study publicly available on registry
July 16, 2013
CompletedResults Posted
Study results publicly available
August 28, 2015
CompletedAugust 28, 2015
August 1, 2015
Same day
July 7, 2013
April 20, 2015
August 14, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
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.
within 24 hrs
Study Arms (1)
Vital Signs Patch (VSP)
EXPERIMENTALInfrared and Red absorbance measurement on chest
Interventions
Infrared and red absorbance measurement
Eligibility Criteria
You may qualify if:
- Ages 23 to 33.
- Skin tone varied from light to dark.
You may not qualify if:
- Smokers
- Anemic
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of California, Room M454, Moffitt Hospital, Box 0542, UCSF,
San Francisco, California, CA 94143, United States
Limitations and Caveats
Not applicable for this trial.
Results Point of Contact
- Title
- Philip E. Bickler, MD, PhD, Professor of Anesthesia
- Organization
- University of California, San Francisco (UCSF)
Study Officials
- PRINCIPAL INVESTIGATOR
Philip E., Bickler, Ph.D., M.D.
University of California, San Francisco
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 7, 2013
First Posted
July 16, 2013
Study Start
March 1, 2013
Primary Completion
March 1, 2013
Study Completion
March 1, 2013
Last Updated
August 28, 2015
Results First Posted
August 28, 2015
Record last verified: 2015-08