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Completed

NCT Number: NCT01899911

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

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.

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Key information

Conditions

Desaturation of Blood

Age range

23 year–33 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, Room M454, Moffitt Hospital, Box 0542, UCSF,

San Francisco, California, CA 94143, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Smokers
  • Anemic

Treatment and study plan

Vital Signs Patch (VSP)

Device

Infrared and red absorbance measurement

Other names: Vital signs Patch, VSP

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

LifeWatch Services, Inc.

Industry

Registry information

Official study title

Pulse Oximeter Response TO Multiple Levels Of Stable Hypoxia

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jul 16, 2013
Registry last updated
Aug 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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