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

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ClinicalTrials.gov Identifier: NCT01899911
Recruitment Status : Completed
First Posted : July 16, 2013
Results First Posted : August 28, 2015
Last Update Posted : August 28, 2015
Sponsor:
Information provided by (Responsible Party):
LifeWatch Services, Inc.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Condition Desaturation of Blood
Intervention Device: Vital Signs Patch (VSP)
Enrollment 12
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Vital Signs Patch (VSP)
Hide 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
Arm/Group Title Vital Signs Patch (VSP)
Hide Arm/Group Description

Infrared and Red absorbance measurement on chest

VSP: Infrared and red absorbance measurement

Overall Number of Baseline Participants 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
<=18 years
0
   0.0%
Between 18 and 65 years
12
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Female
7
  58.3%
Male
5
  41.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Hispanic or Latino
2
  16.7%
Not Hispanic or Latino
10
  83.3%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 12 participants
12
1.Primary Outcome
Title Composite Outcome Measure: Successful Capture of Peripheral Capillary Oxygen Saturation (SpO2) Level
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Peripheral capillary oxygen saturation (SpO2) Measurements Taken on the 12 Participants
Arm/Group Title Vital Signs Patch (VSP)
Hide Arm/Group Description:
Infrared and Red absorbance measurement on chest
Overall Number of Participants Analyzed 12
Measure Type: Number
Unit of Measure: participants
12
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)
Hide 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 (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Vital Signs Patch (VSP)
Affected / at Risk (%)
Total   0/12 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Vital Signs Patch (VSP)
Affected / at Risk (%)
Total   0/12 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Philip E. Bickler, MD, PhD, Professor of Anesthesia
Organization: University of California, San Francisco (UCSF)
Phone: 415-476-1411
Responsible Party: LifeWatch Services, Inc.
ClinicalTrials.gov Identifier: NCT01899911     History of Changes
Other Study ID Numbers: CD-0024
First Submitted: July 7, 2013
First Posted: July 16, 2013
Results First Submitted: April 20, 2015
Results First Posted: August 28, 2015
Last Update Posted: August 28, 2015