Accuracy of ScanWatch Pulse Oximeter With Profound Hypoxia

Oximetry Clinical Trial

Official title:

Accuracy of ScanWatch Pulse Oximeter With Profound Hypoxia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04380389
• Other study ID #: pulse ox
• Status: Completed
• Phase: N/A
• Start date: March 11, 2020
• Est. completion date: March 12, 2020

Study information

• Verified date: May 2020
• Source: Withings
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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 12, 2020
• Est. primary completion date: March 12, 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 has both wrist circumferences between 14 and 22cm.

• 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.

• The subject has piercings that may cause air leaks during the test

• The subject has 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 a resting heartrate over 120, Systolic BP is over 150, diastolic BP is over 90 or room air SpO2 is less than 94%.

• The subject has carboxyhemoglobin over 3% as measured by Lab blood gas analysis.

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

Related Conditions & MeSH terms

• Hypoxia
• Oximetry

Intervention

Diagnostic Test:
• hypoxia
Brief stable arterial oxygen desaturation in healthy volunteers and sampling arterial blood when a stable level of hypoxia has been attained.

Locations

Country	Name	City	State
United States	Hypoxia Lab, UCSF	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Withings

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	RMSE compared to CO-oximetry	Root Mean Squared Error between the functional blood oxygen saturation (SpO2) provided by the device under test and the arterial blood oxygen measured with the CO-oximeter.	1 hour

External Links

•   ISO 80601-2-61:2017 Medical electrical equipment — Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
•   Pulse Oximeters - Premarket Notification Submissions [510(k)s] Guidance for Industry and Food and Drug Administration Staff, March 4, 2013