Oxygen Saturation Clinical Trial
Official title:
Evaluation of Accuracy of Blood Oxygen Saturation Detection Function of Huami Smart Wearable Device
This is a cross-sectional diagnostic study. In this study, wrist oxygen saturation (SwO2) will be measured by Huami smart wearable device, SpO2 of pulse oxygen saturation monitor with medical device registration certificate and SaO2 of arterial blood gas analysis will be used as reference values. A total of 180 group data will be measured in 30~50 patients with SaO2/ SpO2 between 80%∽100%. The investigators aim to evaluate the accuracy of blood oxygen saturation detection function of huami smart wearable device.
This is a cross-sectional diagnostic study. 30~50 inpatient aged 18～85y with SaO2/ SpO2
between 80%∽100% will be recruited from the Department of Respiratory and Critical Care of
Peking University First Hospital. 180 group data ( 37 of SaO2/ SpO2 between 80%∽90%, 143 of
SaO2/ SpO2 between 90%∽100%) will be measured, with an average of 4-6 groups per patient.
Some clinical information such as demographic data, laboratory tests, comorbidity, smoking
habit and will be collected. Patients have their pulse oximetry measured multiple times using
a pulse oximeter/tabletop electrocardiograph with a medical device registration certificate,
and arterial blood gas analysis will be performed if required. While monitoring the pulse
oximetry, a Huami smart wearable device is worn on the ipsilateral wrist to determine blood
oxygen saturation. Primary outcome is the wearable device oximetry accuracy Arms (root mean
square value of the SwO2-RefSpO2 difference) using a medical device registration certificate
pulse oximetry monitor/tabletop ECG monitor as a reference..
The study protocol has been approved by the Peking University First Hospital Institutional
Review Board (IRB) (2020-114). Any protocol modifications will be submitted for the IRB
review and approval.
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