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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vital Signs Patch (VSP) | Experimental | Infrared and Red absorbance measurement on chest |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vital Signs Patch (VSP) | Device | Infrared and red absorbance measurement |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philip E., Bickler, Ph.D., M.D. | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Room M454, Moffitt Hospital, Box 0542, UCSF, | San Francisco | California | CA 94143 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Vital Signs Patch (VSP) | Infrared and Red absorbance measurement on chest VSP: Infrared and red absorbance measurement |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Vital Signs Patch (VSP) | Infrared and Red absorbance measurement on chest VSP: Infrared and red absorbance measurement |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Peripheral capillary oxygen saturation (SpO2) Measurements Taken on the 12 Participants | Posted | Number | participants | within 24 hrs |
|
Adverse event collection was limited to the duration of the study for each participant, which was 24 hours.
No adverse event data was observed during the performance of the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vital Signs Patch (VSP) | Infrared and Red absorbance measurement on chest VSP: Infrared and red absorbance measurement |
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Not applicable for this trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Philip E. Bickler, MD, PhD, Professor of Anesthesia | University of California, San Francisco (UCSF) | 415-476-1411 | Philip.Bickler@UCSF.edu |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
Infrared and Red absorbance measurement on chest
|
|
| 0 |
| 12 |
| 0 |
| 12 |
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