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Performance testing of pulse oximeters. The protocol involves brief stable arterial oxygen desaturation in healthy volunteers and sampling arterial blood when a stable level of hypoxia has been attained. The blood sample is analyzed for oxygen saturation with a gold standard bench CO-oximeter. This protocol is aligned with the latest ISO and FDA guidance documents for pulse oximeter testing.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Owlet Smart Sock Sensor 3rd Generation | Diagnostic Test | Pulse Oximetry |
| Measure | Description | Time Frame |
|---|---|---|
| SpO2 Accuracy (Arms) of ≤3 Between 70 and 100% | Determination of Average Root Mean Square SpO2 Accuracy of the Owlet Smart Sock 3rd Generation | 1 hour |
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Inclusion Criteria:
Exclusion Criteria:
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Participants in this study should be healthy, between 18 and 50 years of age and willing to participate in breathing studies with or without blood samples in San Francisco.
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| Name | Affiliation | Role |
|---|---|---|
| Philip Bickler, MD | UCSF Department of Anesthesia | Principal Investigator |
| John Feiner, MD | UCSF Department of Anesthesia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University California San Fransisco, Department of Anesthesia | San Francisco | California | 94133 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | ARMS SpO2 70-100% | Comparison to Reference CO-Oximetry Accuracy of the Owlet Smart Sock Sensor 3rd Generation: The purpose of this study was to validate the SpO2 accuracy of the Owlet Smart Sock Sensor 3rd Generation during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry. It was expected that the Accuracy Root Mean Square (ARMS) performance of the oximetry system would meet the required specification of ARMS of 3.0% or less. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
14 Healthy volunteer subjects
| ID | Title | Description |
|---|---|---|
| BG000 | ARMS SpO2 70-100% | Comparison to Reference CO-Oximetry Accuracy of the Owlet Smart Sock Sensor 3rd Generation: The purpose of this study was to validate the SpO2 accuracy of the Owlet Smart Sock Sensor 3rd Generation during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry. It was expected that the Accuracy Root Mean Square (ARMS) performance of the oximetry system would meet the required specification of ARMS of 3.0% or less. |
| 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 | SpO2 Accuracy (Arms) of ≤3 Between 70 and 100% | Determination of Average Root Mean Square SpO2 Accuracy of the Owlet Smart Sock 3rd Generation | Posted | Number | Percentage | 1 hour | Number of Data Points | Number of Data Points |
|
Study Duration (approximately 1 hour)
All subjects completed the study without events.
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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 | ARMS SpO2 70-100%, Oximeter #1 (Left) | Comparison to Reference CO-Oximetry on the left thumb. Accuracy of the Owlet Smart Sock Sensor 3rd Generation: The purpose of this study was to validate the SpO2 accuracy of the Owlet Smart Sock Sensor 3rd Generation during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry. It was expected that the Accuracy Root Mean Square (ARMS) performance of the oximetry system would meet the required specification of ARMS of 3.0% or less. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Madison Kenley, Clinical Research Director | Owlet Baby Care, Inc | 801-552-8383 | mkenley@owletcare.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 22, 2019 | Sep 22, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000860 | Hypoxia |
| ID | Term |
|---|---|
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Arterial Blood Samples |
|
| Participants |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants | Participants |
|
| Region of Enrollment | Number | participants | Participants |
|
| Skin Tone | Count of Participants | Participants | Participants |
|
Comparison to Reference CO-Oximetry on the right thumb. Accuracy of the Owlet Smart Sock Sensor 3rd Generation: The purpose of this study was to validate the SpO2 accuracy of the Owlet Smart Sock Sensor 3rd Generation during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry. It was expected that the Accuracy Root Mean Square (ARMS) performance of the oximetry system would meet the required specification of ARMS of 3.0% or less. |
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | ARMS SpO2 70-100%, Oximeter #2 (Right) | Comparison to Reference CO-Oximetry on the left thumb. Accuracy of the Owlet Smart Sock Sensor 3rd Generation: The purpose of this study was to validate the SpO2 accuracy of the Owlet Smart Sock Sensor 3rd Generation during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry. It was expected that the Accuracy Root Mean Square (ARMS) performance of the oximetry system would meet the required specification of ARMS of 3.0% or less. | 0 | 14 | 0 | 14 | 0 | 14 |
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