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

• Sponsor: LifeWatch Services, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01899911
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Arm: 1

Study Details

Study Description

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)	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: N/A
• 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: Mar 1, 2013
• Actual Primary Completion Date: Mar 1, 2013
• Actual Study Completion Date: Mar 1, 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 23 Years to 33 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Ages 23 to 33.

• Skin tone varied from light to dark.

Exclusion Criteria:

• Smokers

• Anemic

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California, Room M454, Moffitt Hospital, Box 0542, UCSF,	San Francisco	California	United States	CA 94143

Sponsors and Collaborators

• LifeWatch Services, Inc.

Investigators

• Principal Investigator: Philip E., Bickler, Ph.D., M.D., University of California, San Francisco

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: LifeWatch Services, Inc.
• ClinicalTrials.gov Identifier: NCT01899911
• Other Study ID Numbers: CD-0024
• First Posted: Jul 16, 2013
• Last Update Posted: Aug 28, 2015
• Last Verified: Aug 1, 2015

Study Results

Participant Flow

Arm/Group Title	Vital Signs Patch (VSP)
Arm/Group Description	Infrared and Red absorbance measurement on chest VSP: Infrared and red absorbance measurement
Period Title: Overall Study
STARTED	12
COMPLETED	12
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Vital Signs Patch (VSP)
Arm/Group Description	Infrared and Red absorbance measurement on chest VSP: Infrared and red absorbance measurement
Overall Participants	12
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	12 100%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	7 58.3%
Male	5 41.7%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	2 16.7%
Not Hispanic or Latino	10 83.3%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	12 100%

Outcome Measures

1. Primary Outcome

Title	Composite Outcome Measure: Successful Capture of Peripheral Capillary Oxygen Saturation (SpO2) Level
Description	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.
Time Frame	within 24 hrs

Outcome Measure Data

Analysis Population Description

Peripheral capillary oxygen saturation (SpO2) Measurements Taken on the 12 Participants

Arm/Group Title	Vital Signs Patch (VSP)
Arm/Group Description	Infrared and Red absorbance measurement on chest
Measure Participants	12
Number [participants]	12 100%

Adverse Events

Time Frame	Adverse event collection was limited to the duration of the study for each participant, which was 24 hours.
Adverse Event Reporting Description	No adverse event data was observed during the performance of the study.
Arm/Group Title	Vital Signs Patch (VSP)
Arm/Group Description	Infrared and Red absorbance measurement on chest VSP: Infrared and red absorbance measurement
All Cause Mortality
	Vital Signs Patch (VSP)
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Vital Signs Patch (VSP)
	Affected / at Risk (%)	# Events
Total	0/12 (0%)
Other (Not Including Serious) Adverse Events
	Vital Signs Patch (VSP)
	Affected / at Risk (%)	# Events
Total	0/12 (0%)

Limitations/Caveats

Not applicable for this trial.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.