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

NCT03630016 | Completed Results FDA Device

• 1 other identifier: PR2017-263
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypoxia

Outcome Measures

Primary Outcomes (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%

  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.

  Acute immediate assessment of the sensor accuracy compared to CO-oximetry

Study Arms (3)

Reference CO-Oximetry

ACTIVE COMPARATOR

Reference Co-Oximetry

Diagnostic Test: Pulse oximetry with Owlet BabySat v1.0 sensor

Owlet BabySat v1.0

EXPERIMENTAL

Owlet BabySat v1.0

Diagnostic Test: Pulse oximetry with Owlet BabySat v1.0 sensor

Owlet Smart Sock V2 v1.1

EXPERIMENTAL

Owlet Smart SockTM 2 , OSS v1.1 Sensor and Custom Adult Thumb Sock

Diagnostic Test: Pulse oximetry with Owlet BabySat v1.0 sensor

Interventions

Pulse oximetry with Owlet BabySat v1.0 sensor DIAGNOSTIC_TEST

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

Owlet BabySat v1.0; Owlet Smart Sock V2 v1.1; Reference CO-Oximetry

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Owlet Baby Care, Inc.: lead
• Clinimark, LLC: collaborator

Study Sites (1)

Owlet Baby Care, Inc.

Lehi, Utah, 84043, United States

Location

MeSH Terms

Conditions

Hypoxia

Interventions

Oximetry

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Blood Gas Analysis; Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Investigative Techniques

Results Point of Contact

• Title: Madison Kenley, CCRP, BS
• Organization: Owlet Baby Care, Inc.

mkenley@owletcare.com

801-552-8383

Study Officials

• Milena Adamian, MD

  Owlet Baby Care, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2018
• First Posted: August 14, 2018
• Study Start: December 13, 2017
• Primary Completion: December 17, 2017
• Study Completion: December 17, 2017
• Last Updated: July 23, 2019
• Results First Posted: July 23, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)