An interventional study of Pulse oximetry with Owlet BabySat v1.0 sensor in Hypoxia, sponsored by Owlet Baby Care, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-07-23.
Sponsored by Owlet Baby Care, Inc. · Not applicable, Interventional, and Diagnostic
Pulse oximetry monitoring is considered a standard physiological measurement and is used by clinicians in everyday situations to estimate arterial oxygen saturation. There are two devices used in this investigational study: BabySat v.1.0 and Owlet Baby Care, Inc. Smart SockTM 2 (currently available over-the-counter), with specific emphasis on its pulse oximetry accuracy. The BabySat and Smart SockTM 2 are non-invasive home care devices for use with infants. The purpose of this study was to validate the SpO2 accuracy of BabySat v1.0 and Owlet Smart SockTM 2, OSS v1.1 sensors pulse oximetry, during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry.
Pulse oximetry monitoring is considered a standard physiological measurement and is used by clinicians in everyday situations to estimate arterial oxygen saturation. A pulse oximeter is a device that measures the oxygen saturation of arterial blood non-invasively.
The purpose of this study was to evaluate the SpO2 accuracy performance of the Owlet BabySat v1.0 and Smart SockTM 2 pulse oximetry OSS v1.1 sensors during non-motion conditions over the range of 70-100% SaO2 to arterial blood samples assessed by CO-Oximetry for a SpO2 validation.
The goal, in its entirety, was to show the SpO2 accuracy performance for the investigational device Owlet Baby Care, Inc. Smart SockTM V. 2.
It was expected that the Accuracy Root Mean Square (ARMS) performance would meet the required specification of ARMS 3% or lower in non-motion conditions for the range of 70 - 100% SaO2 thereby demonstrating an acceptable SpO2 accuracy performance specification.
No risks or adverse device effects were expected. There were no contraindications for use in the proposed study population.
The study was conducted in accordance to the code of federal regulations for non-significant risk medical device studies and applicable ISO 14155 (2nd edition 2011-02-01), applicable sections of ISO80601-2-61 (1st edition 2011-04- 01), and Pulse Oximeters - Premarket Notifications Submissions [510(k)s] Guidance For Industry and Food and Drug Administration Staff (issued: March 4, 2013)
1,231 studies on the registry are indexed under Hypoxia; 241 are open to participants now.
This study's enrollment of 11 is below the median of 45 across 853 interventional studies indexed under Hypoxia.
Browse Hypoxia studies →Owlet Baby Care, Inc. is the lead sponsor of 10 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Reference Co-Oximetry
Diagnostic Test: Pulse oximetry with Owlet BabySat v1.0 sensor
Owlet BabySat v1.0
Diagnostic Test: Pulse oximetry with Owlet BabySat v1.0 sensor
Owlet Smart SockTM 2 , OSS v1.1 Sensor and Custom Adult Thumb Sock
Diagnostic Test: Pulse oximetry with Owlet BabySat v1.0 sensor
A comparative, single-center, non-randomized study to evaluate the SpO2 accuracy guidelines for pulse oximetry over the range of 70-100% SaO2 under non-motion conditions. Arterial blood sampling measured by functional SaO2 CO-Oximetry, was used as the basis for comparison with Owlet BabySat v1.0 and Owlet Smart Sock 2 sensors
It Was Expected That the Accuracy Root Mean Square (ARMS) Between Measured SpO2 of Owlet Smart Sock V2 v1.1 and Reference SpO2 Would Meet the Required Specification of ARMS 3% or Lower in Non-motion Conditions for the Range of 70 - 100%
The purpose of the study was to evaluate the accuracy of the blood oxygen saturation (SpO2) at rest over the range of 70-100% compared to arterial blood samples assessed by standard methods \[Co-Oximetry\]. A standard pulse oximeter accuracy is evaluated by the Accuracy Root Mean Square (ARMS). The results of accurate performance of the oximetry system require ARMS of 3% or less in non-motion conditions for the range of 70-100% SpO2 per standard.
Time frame: Acute immediate assessment of the sensor accuracy compared to CO-oximetry
| Milestone | Owlet Smart Sock V2 v1.1 |
|---|---|
| Started | 11 |
| Completed | 10 |
| Not completed | 1 |
| Withdrew: Poor sensor placement | 1 |
The purpose of the study was to evaluate the accuracy of the blood oxygen saturation (SpO2) at rest over the range of 70-100% compared to arterial blood samples assessed by standard methods \[Co-Oximetry\]. A standard pulse oximeter accuracy is evaluated by the Accuracy Root Mean Square (ARMS). The results of accurate performance of the oximetry system require ARMS of 3% or less in non-motion conditions for the range of 70-100% SpO2 per standard.
| Percent SpO2 | Owlet Smart Sock V2 v1.1 |
|---|---|
| It Was Expected That the Accuracy Root Mean Square (ARMS) Between Measured SpO2 of Owlet Smart Sock V2 v1.1 and Reference SpO2 Would Meet the Required Specification of ARMS 3% or Lower in Non-motion Conditions for the Range of 70 - 100% | 2.4 |
Collected over Throughout study duration and a follow-up with each subject will be conducted within 7 days following participation in the study and will be conducted via telephone, text or email.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Owlet Smart Sock V2 v1.1 | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) |
| Age, Categorical(Participants) | Owlet Smart Sock V2 v1.1 |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 10 |
| >=65 years | 0 |
| Age, Continuous(years) | Owlet Smart Sock V2 v1.1 |
|---|---|
| Mean | 29.2 ± 7.2 |
| Sex: Female, Male(Participants) | Owlet Smart Sock V2 v1.1 |
|---|---|
| Female | 4 |
| Male | 6 |
| Ethnicity (NIH/OMB)(Participants) | Owlet Smart Sock V2 v1.1 |
|---|---|
| Hispanic or Latino | 2 |
| Not Hispanic or Latino | 8 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Owlet Smart Sock V2 v1.1 |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 2 |
| White | 7 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Owlet Smart Sock V2 v1.1 |
|---|---|
| United States | 10 |
| Weight(lbs) | Owlet Smart Sock V2 v1.1 |
|---|---|
| Mean | 159.8 ± 25.8 |
| Height(inches) | Owlet Smart Sock V2 v1.1 |
|---|---|
| Mean | 68.1 ± 4.3 |
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Owlet Baby Care, Inc.