Accuracy of ScanWatch Pulse Oximeter With Profound Hypoxia

NCT ID: NCT04380389

Last Updated: 2020-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-11
• Study Completion Date: 2020-03-12

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.

Conditions

Oximetry

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

profound hypoxia

Group Type: OTHER

hypoxia

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

hypoxia

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Withings

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hypoxia Lab, UCSF

San Francisco, California, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 33857011 (View on PubMed)

Related Links

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/pulse-oximeters-premarket-notification-submissions-510ks-guidance-industry-and-food-and-drug

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

https://www.iso.org/fr/standard/67963.html

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

Other Identifiers

pulse ox

Identifier Type: -

Identifier Source: org_study_id