Clinical trial NCT04429906: Diagnostic Study of Huami Smart Wearable Device
Official title: Evaluation of Accuracy of Blood Oxygen Saturation Detection Function of Huami Smart Wearable Device
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Oxygen Saturation
Keywords: Oxygen saturation Smart wearable device Accuracy
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
Collaborators: name: Anhui Huami Information Technology Co., Ltd.
First posted: 2020-06-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inpatients in the Department of Respiratory and Critical Care at Peking University First Hospital

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Inpatients in the Department of Respiratory and Critical Care at Peking University First Hospital
2. Oxygen intake or no oxygen intake when enrolled: 80%≤SaO2/SpO2≤100%
3. Age between 18 and 85 years, either gender
4. COHb\<3%, MetHb\<2%;
5. Sign an informed consent or sign an informed consent by a legally authorized representative;
6. Be willing and able to follow the research program.

Exclusion Criteria:

1. current smokers or those exposed to high levels of carbon monoxide.
2. critically ill patients who are in a state of shock, resulting in peripheral circulation disorders.
3. Patients with hypothermia below 35°C.
4. Patients with bilateral wrist and hand oedema, soft tissue damage to the wrist, skin incomplete and unable to wear a watch/ bracelet.
5. Vascular blood supply abnormalities of both upper limbs (occlusion, thrombosis, post-trauma, etc.), which affects the test results
6. Patients with bilateral upper extremity pigmentation affecting the test results;
7. Patients with limb mobility impairment due to severe cerebrovascular disease sequelae.
8. Patients with severe mental system disease that makes it impossible to cooperate with the researchers.

Primary outcomes:
measure: Wearable device oximetry accuracy Arms
timeFrame: 30mins
Secondary outcomes:
measure: Wearable device blood oxygen saturation accuracy Arms
timeFrame: 30mins
measure: Accuracy of blood oxygen saturation of wearable devices when SpO2/SaO2 is at 90%-100%.
timeFrame: 30mins
measure: Accuracy of blood oxygen saturation of wearable devices when SpO2/SaO2 is at 80%-89%.
timeFrame: 30mins
measure: Correlation analysis of parameters that have an impact on the accuracy of blood oxygen saturation of wearable devices.
timeFrame: 30mins
measure: The variability of blood oxygen saturation of wearable devices tested three times.
timeFrame: 30mins
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
Study officials:
References: