SpO2 Accuracy Comparison of Smart Sock V. 2 SpO2 to Arterial Blood CO-Oximetry
Primary Purpose
Hypoxia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pulse oximetry with Owlet BabySat v1.0 sensor
Sponsored by
About this trial
This is an interventional diagnostic trial for Hypoxia
Eligibility Criteria
Inclusion Criteria:
- 10-15 Adults with a minimum of 3 males and a minimum of 3 females, with the balance, made up of either.
- Subject must have the ability to understand and provide written informed consent
- Subject is 18 to 50 years of age
- At least 2 darkly pigmented subjects or 15% of the subject pool, whichever is larger
- Subject must be willing and able to comply with study procedures and duration
- Subject is a non-smoker or who have not smoked within 2 days prior to the study.
Exclusion Criteria:
- Subject is considered as being morbidly obese (defined as BMI >39.5)
- Compromised circulation, injury, or physical malformation of fingers, toes, hands, ears or forehead/skull or other sensor sites which would limit the ability to test sites needed for the study
- Females who are pregnant, who are trying to get pregnant
- Smoker Subjects who have refrained will be screened for COHb levels
- Subjects with known heart or cardiovascular conditions
- Subjects with known clotting disorders
Sites / Locations
- Owlet Baby Care, Inc.
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Reference CO-Oximetry
Owlet BabySat v1.0
Owlet Smart Sock V2 v1.1
Arm Description
Reference Co-Oximetry
Owlet BabySat v1.0
Owlet Smart SockTM 2 , OSS v1.1 Sensor and Custom Adult Thumb Sock
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03630016
First Posted
August 3, 2018
Last Updated
July 1, 2019
Sponsor
Owlet Baby Care, Inc.
Collaborators
Clinimark, LLC
1. Study Identification
Unique Protocol Identification Number
NCT03630016
Brief Title
SpO2 Accuracy Comparison of Smart Sock V. 2 SpO2 to Arterial Blood CO-Oximetry
Official Title
SpO2 Accuracy Comparison of Smart Sock V. 2 SpO2 to Arterial Blood CO-Oximetry
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
December 13, 2017 (Actual)
Primary Completion Date
December 17, 2017 (Actual)
Study Completion Date
December 17, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Owlet Baby Care, Inc.
Collaborators
Clinimark, LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxia
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Reference CO-Oximetry
Arm Type
Active Comparator
Arm Description
Reference Co-Oximetry
Arm Title
Owlet BabySat v1.0
Arm Type
Experimental
Arm Description
Owlet BabySat v1.0
Arm Title
Owlet Smart Sock V2 v1.1
Arm Type
Experimental
Arm Description
Owlet Smart SockTM 2 , OSS v1.1 Sensor and Custom Adult Thumb Sock
Intervention Type
Diagnostic Test
Intervention Name(s)
Pulse oximetry with Owlet BabySat v1.0 sensor
Intervention Description
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
Primary Outcome Measure Information:
Title
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%
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
10-15 Adults with a minimum of 3 males and a minimum of 3 females, with the balance, made up of either.
Subject must have the ability to understand and provide written informed consent
Subject is 18 to 50 years of age
At least 2 darkly pigmented subjects or 15% of the subject pool, whichever is larger
Subject must be willing and able to comply with study procedures and duration
Subject is a non-smoker or who have not smoked within 2 days prior to the study.
Exclusion Criteria:
Subject is considered as being morbidly obese (defined as BMI >39.5)
Compromised circulation, injury, or physical malformation of fingers, toes, hands, ears or forehead/skull or other sensor sites which would limit the ability to test sites needed for the study
Females who are pregnant, who are trying to get pregnant
Smoker Subjects who have refrained will be screened for COHb levels
Subjects with known heart or cardiovascular conditions
Subjects with known clotting disorders
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Milena Adamian, MD
Organizational Affiliation
Owlet Baby Care, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Owlet Baby Care, Inc.
City
Lehi
State/Province
Utah
ZIP/Postal Code
84043
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
SpO2 Accuracy Comparison of Smart Sock V. 2 SpO2 to Arterial Blood CO-Oximetry
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