Desaturation of Blood
Conditions
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.
Interventions
DEVICEVital Signs Patch (VSP)
Infrared and red absorbance measurement
Sponsors
LifeWatch Services, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
23 Years to 33 Years
Healthy volunteers
Yes
Inclusion criteria
* Ages 23 to 33. * Skin tone varied from light to dark.
Exclusion criteria
* Smokers * Anemic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Vital Signs Patch (VSP) Infrared and Red absorbance measurement on chest
VSP: Infrared and red absorbance measurement | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | Vital Signs Patch (VSP) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Region of Enrollment United States | 12 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
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.
Time frame: within 24 hrs
Population: Peripheral capillary oxygen saturation (SpO2) Measurements Taken on the 12 Participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vital Signs Patch (VSP) | Composite Outcome Measure: Successful Capture of Peripheral Capillary Oxygen Saturation (SpO2) Level | 12 participants |