Clinical trial NCT04380389: Accuracy of ScanWatch Pulse Oximeter With Profound Hypoxia
Official title: Accuracy of ScanWatch Pulse Oximeter With Profound Hypoxia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oximetry
Lead sponsor: Withings
Sponsor class: INDUSTRY
First posted: 2020-05-08
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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.

Primary outcomes:
measure: RMSE compared to CO-oximetry
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Hypoxia Lab, UCSF
state: California
Study officials:
References:
citation: 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.