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Clinical Study of Peripheral Capillary Oxygen Saturation (SpO2): Vital Signs Patch (VSP)

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ClinicalTrials.gov Identifier: NCT01899911
Recruitment Status : Completed
First Posted : July 16, 2013
Results First Posted : August 28, 2015
Last Update Posted : August 28, 2015
Sponsor:
Information provided by (Responsible Party):
LifeWatch Services, Inc.

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.

Condition or disease Intervention/treatment Phase
Desaturation of Blood Device: Vital Signs Patch (VSP) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Pulse Oximeter Response TO Multiple Levels Of Stable Hypoxia
Study Start Date : March 2013
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Vital Signs Patch (VSP)
Infrared and Red absorbance measurement on chest
Device: Vital Signs Patch (VSP)
Infrared and red absorbance measurement
Other Names:
  • Vital signs Patch
  • VSP




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   23 Years to 33 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Ages 23 to 33.
  • Skin tone varied from light to dark.

Exclusion Criteria:

  • Smokers
  • Anemic

Information from the National Library of Medicine

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): NCT01899911


Locations
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United States, California
University of California, Room M454, Moffitt Hospital, Box 0542, UCSF,
San Francisco, California, United States, CA 94143
Sponsors and Collaborators
LifeWatch Services, Inc.
Investigators
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Principal Investigator: Philip E. , Bickler, Ph.D., M.D. University of California, San Francisco

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Responsible Party: LifeWatch Services, Inc.
ClinicalTrials.gov Identifier: NCT01899911     History of Changes
Other Study ID Numbers: CD-0024
First Posted: July 16, 2013    Key Record Dates
Results First Posted: August 28, 2015
Last Update Posted: August 28, 2015
Last Verified: August 2015