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

LifeWatch Services

Status: Completed

Conditions: Desaturation of Blood

Treatments: Device: Vital Signs Patch (VSP)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01899911

CD-0024

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 23 to 33 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Smokers
• Anemic

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Vital Signs Patch (VSP)

Experimental group

Description:

Infrared and Red absorbance measurement on chest

Treatment:

Device: Vital Signs Patch (VSP)