Accuracy of Owlet Smart Sock Sensor 3rd Generation With Profound Hypoxia

Hypoxia Clinical Trial

Official title:

Accuracy of Owlet Smart Sock Sensor 3rd Generation With Profound Hypoxia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04446247
• Other study ID #: 10-00437
• Status: Completed
• Start date: March 12, 2020
• Est. completion date: March 13, 2020

Study information

• Verified date: September 2020
• Source: Owlet Baby Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: March 13, 2020
• Est. primary completion date: March 13, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 49 Years

Eligibility

Inclusion Criteria:

• The subject is male or female, aged =18 and <50.

• The subject is in good general health with no evidence of any medical problems.

• The subject is fluent in both written and spoken English.

• The subject has provided informed consent and is willing to comply with the study procedures.

Exclusion Criteria:

• The subject is obese (BMI>30).

• The subject has a known history of heart disease, lung disease, kidney or liver disease.

• Diagnosis of asthma, sleep apnea, or use of CPAP.

• Subject has diabetes.

• Subject has a clotting disorder.

• The subject a hemoglobinopathy or history of anemia, per subject report or the first blood sample, that in the opinion of the investigator, would make them unsuitable for study participation.

• The subject has any other serious systemic illness.

• The subject is a current smoker.

• Any injury, deformity, or abnormality at the sensor sites that in the opinion of the investigators' would interfere with the sensors working correctly.

• The subject has a history of fainting or vasovagal response.

• The subject has a history of sensitivity to local anesthesia.

• The subject has a diagnosis of Raynaud's disease.

• The subject has unacceptable collateral circulation based on exam by the investigator (Allen's test).

• The subject is pregnant, lactating or trying to get pregnant.

• The subject is unable or unwilling to provide informed consent, or is unable or unwilling to comply with study procedures.

• The subject has any other condition, which in the opinion of the investigators' would make them unsuitable for the study.

Related Conditions & MeSH terms

• Hypoxia

Intervention

Diagnostic Test:
• Owlet Smart Sock Sensor 3rd Generation
Pulse Oximetry

Locations

Country	Name	City	State
United States	University California San Fransisco, Department of Anesthesia	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Owlet Baby Care, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	1 hour