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SpO2 Accuracy Comparison of Smart Sock V. 2 SpO2 to Arterial Blood CO-Oximetry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03630016
Recruitment Status : Completed
First Posted : August 14, 2018
Results First Posted : July 23, 2019
Last Update Posted : July 23, 2019
Sponsor:
Collaborator:
Clinimark, LLC
Information provided by (Responsible Party):
Owlet Baby Care, Inc.

Tracking Information
First Submitted Date  ICMJE August 3, 2018
First Posted Date  ICMJE August 14, 2018
Results First Submitted Date  ICMJE May 9, 2019
Results First Posted Date  ICMJE July 23, 2019
Last Update Posted Date July 23, 2019
Actual Study Start Date  ICMJE December 13, 2017
Actual Primary Completion Date December 17, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 1, 2019)
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% [ Time Frame: Acute immediate assessment of the sensor accuracy compared to CO-oximetry ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 13, 2018)
Accuracy root mean square (ARMS) between measured SpO2 and reference SaO2 below 3% [ Time Frame: Acute immediate assessment of the sensor accuracy compared to CO-oximetry ]
SpO2 accuracy for Owlet Smart Sock 2 sensor
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE SpO2 Accuracy Comparison of Smart Sock V. 2 SpO2 to Arterial Blood CO-Oximetry
Official Title  ICMJE SpO2 Accuracy Comparison of Smart Sock V. 2 SpO2 to Arterial Blood CO-Oximetry
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)

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Hypoxia
Intervention  ICMJE 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
Study Arms  ICMJE
  • Active Comparator: Reference CO-Oximetry
    Reference Co-Oximetry
    Intervention: Diagnostic Test: Pulse oximetry with Owlet BabySat v1.0 sensor
  • Experimental: Owlet BabySat v1.0
    Owlet BabySat v1.0
    Intervention: Diagnostic Test: Pulse oximetry with Owlet BabySat v1.0 sensor
  • Experimental: Owlet Smart Sock V2 v1.1
    Owlet Smart SockTM 2 , OSS v1.1 Sensor and Custom Adult Thumb Sock
    Intervention: Diagnostic Test: Pulse oximetry with Owlet BabySat v1.0 sensor
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 13, 2018)
11
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 17, 2017
Actual Primary Completion Date December 17, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03630016
Other Study ID Numbers  ICMJE PR2017-263
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Owlet Baby Care, Inc.
Study Sponsor  ICMJE Owlet Baby Care, Inc.
Collaborators  ICMJE Clinimark, LLC
Investigators  ICMJE
Study Director: Milena Adamian, MD Owlet Baby Care, Inc.
PRS Account Owlet Baby Care, Inc.
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP