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

Not Applicable

Completed

• Conditions: Desaturation of Blood
• Interventions: Device: Vital Signs Patch (VSP)

• Registration Number: NCT01899911
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2013-03
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Study First Submitted: 2013-07-07
• Study First Submitted QC: 2013-07-15
• Study First Posted: 2013-07-16
• Results First Submitted: 2015-04-20
• Status Verified: 2015-08
• Results First Submitted QC: 2015-08-14
• Last Update Submitted: 2015-08-14
• Results First Posted: 2015-08-28
• Last Update Posted: 2015-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

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

Exclusion Criteria

• Smokers
• Anemic

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vital Signs Patch (VSP)	Vital Signs Patch (VSP)	Infrared and Red absorbance measurement on chest

Primary Outcome Measures

Name	Time	Method
Composite Outcome Measure: Successful Capture of Peripheral Capillary Oxygen Saturation (SpO2) Level	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.

Trial Locations

Locations (1)

University of California, Room M454, Moffitt Hospital, Box 0542, UCSF,; 🇺🇸 San Francisco, California, United States