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

Desaturation of Blood Clinical Trial

Official title:

Pulse Oximeter Response TO Multiple Levels Of Stable Hypoxia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01899911
• Other study ID #: CD-0024
• Status: Completed
• Phase: N/A
• First received: July 7, 2013
• Last updated: August 14, 2015
• Start date: March 2013
• Est. completion date: March 2013

Study information

• Verified date: August 2015
• Source: LifeWatch Services, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 23 Years to 33 Years

Eligibility

Inclusion Criteria:

• Ages 23 to 33.

• Skin tone varied from light to dark.

Exclusion Criteria:

• Smokers

• Anemic

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Desaturation of Blood

Intervention

Device:
• Vital Signs Patch (VSP)
Infrared and red absorbance measurement

Locations

Country	Name	City	State
United States	University of California, Room M454, Moffitt Hospital, Box 0542, UCSF,	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
LifeWatch Services, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No