Accuracy of ScanWatch Pulse Oximeter With Profound Hypoxia

• ClinicalTrials.gov Identifier: NCT04380389
• Recruitment Status: Completed
• First Posted: May 8, 2020
• Last Update Posted: May 8, 2020
• Sponsor: Withings
• Information provided by (Responsible Party): Withings

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Oximetry	Diagnostic Test: hypoxia	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 14 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Accuracy of ScanWatch Pulse Oximeter With Profound Hypoxia
• Actual Study Start Date: March 11, 2020
• Actual Primary Completion Date: March 12, 2020
• Actual Study Completion Date: March 12, 2020

Arms and Interventions

Arm	Intervention/treatment
profound hypoxia	Diagnostic Test: hypoxia; Brief stable arterial oxygen desaturation in healthy volunteers and sampling arterial blood when a stable level of hypoxia has been attained.

Outcome Measures

Primary Outcome Measures :

1. RMSE compared to CO-oximetry [ Time Frame: 1 hour ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 49 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Locations

United States, California

Hypoxia Lab, UCSF

San Francisco, California, United States, 94133

Sponsors and Collaborators

Withings

More Information

Additional Information:

Pulse Oximeters - Premarket Notification Submissions [510(k)s] Guidance for Industry and Food and Drug Administration Staff, March 4, 2013 

ISO 80601-2-61:2017 Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Kirszenblat R, Edouard P. Validation of the Withings ScanWatch as a Wrist-Worn Reflective Pulse Oximeter: Prospective Interventional Clinical Study. J Med Internet Res. 2021 Apr 26;23(4):e27503. doi: 10.2196/27503.

• Responsible Party: Withings
• ClinicalTrials.gov Identifier: NCT04380389
• Other Study ID Numbers: pulse ox
• First Posted: May 8, 2020
• Last Update Posted: May 8, 2020
• Last Verified: May 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Additional relevant MeSH terms:

Hypoxia; Signs and Symptoms, Respiratory