Diagnostic Study of Huami Smart Wearable Device (DSHWD)

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.

Study Overview

• Status: Unknown
• Conditions: Oxygen Saturation
• Intervention / Treatment: Device: 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.

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100034
      • Recruiting
      • Peking University First Hospital
      • Contact: Guangfa Wang, MD.; Phone Number: 13810644029; Email: wangguangfa@hotmail.com
      • Contact: Jiping Liao, PhD.; Phone Number: 13521714181; Email: colorfulwing01@163.com
      • Sub-Investigator: Chunbo Zhang
      • Sub-Investigator: Zhu Tian

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Inpatients in the Department of Respiratory and Critical Care at Peking University First Hospital

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
test group; Wear the pulse-oxygen monitoring finger set of the medical monitor while wearing the Huami Smart Wearable device on the ipsilateral wrist according to the instructions for use. The medical monitor displays a steady pulse oximetry level for at least 30 seconds, starts the first measurement, slides the main dial page of the wearable device to the "Oxygen Saturation" measurement interface, clicks the measurement button to start the single measurement of blood oxygen saturation. Record the pulse oximetry and pulse rate values measured at the same time by the medical monitor and the Huami Smart Wearable Pulse Oximetry Device, respectively. After an interval of 30 seconds, repeat the above steps to start the second measurement and record the measured value. After an interval of 30 seconds, repeat the above steps to start the third measurement and record the measured value. The average of three measurements was taken as data for the test group.	Device: Huami smart wearable device; Wear the pulse-oxygen monitoring finger set of the medical monitor while wearing the Huami Smart Wearable device on the ipsilateral wrist according to the instructions for use. The medical monitor displays a steady pulse oximetry level for at least 30 seconds, starts the first measurement, slides the main dial page of the wearable device to the "Oxygen Saturation" measurement interface, clicks the measurement button to start the single measurement of blood oxygen saturation. Record the pulse oximetry and pulse rate values measured at the same time by the medical monitor and the Huami Smart Wearable Pulse Oximetry Device, respectively. After an interval of 30 seconds, repeat the above steps to start the second measurement and record the measured value. After an interval of 30 seconds, repeat the above steps to start the third measurement and record the measured value. The average of three measurements was taken as data for the test group.
control group A; Pulse oximetry monitor/desktop ECG monitor with a medical device registration certificate was selected as reference device A. The mean value of qualified pulse oximetry measured by pulse oximetry monitor/desktop ECG monitor within 2 minutes of each successive measurement of the Huami Smart Wearable Device was used as control group A measurement.
control group B; A carbon monoxide blood gas analyzer (CO-oximeter) was selected as reference device B. Arterial blood was sampled and arterial oxygen saturation (SaO2) was obtained from the blood gas analyzer as a control group B measurement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wearable device oximetry accuracy Arms	Record the pulse oximetry and pulse rate values measured at the same time by the medical monitor and the Huami Smart Wearable Pulse Oximetry Device, respectively. After an interval of 30 seconds, repeat the above steps to start the second measurement and record the measured value. After an interval of 30 seconds, repeat the above steps to start the third measurement and record the measured value. The average of three measurements was taken as data for the test group. Pulse oximetry monitor/desktop ECG monitor with a medical device registration certificate was selected as reference device A. The mean value of qualified pulse oximetry measured by pulse oximetry monitor/desktop ECG monitor was used as control group A measurement. 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.	30mins

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wearable device blood oxygen saturation accuracy Arms	Record the pulse oximetry and pulse rate values measured by the Huami Smart Wearable Pulse Oximetry Device. After an interval of 30 seconds, repeat the above steps to start the second measurement and record the measured value. After an interval of 30 seconds, repeat the above steps to start the third measurement and record the measured value. The average of three measurements was taken as data for the test group.A carbon monoxide blood gas analyzer (CO-oximeter) was selected as reference device B. Arterial blood was sampled and arterial oxygen saturation (SaO2) was obtained from the blood gas analyzer as a control group B measurement.Wearable device blood oxygen saturation accuracy Arms (expressed as root mean square value of the SwO2-SaO2 difference) using a carbon monoxide - blood gas analyzer (CO-oximeter) as reference.	30mins
Accuracy of blood oxygen saturation of wearable devices when SpO2/SaO2 is at 90%-100%.	When SpO2/SaO2 is at 90%-100%,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;wearable device blood oxygen saturation accuracy Arms (expressed as root mean square value of the SwO2-SaO2 difference) using a carbon monoxide - blood gas analyzer (CO-oximeter) as reference.	30mins
Accuracy of blood oxygen saturation of wearable devices when SpO2/SaO2 is at 80%-89%.	when SpO2/SaO2 is at 80%-89%,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;wearable device blood oxygen saturation accuracy Arms (expressed as root mean square value of the SwO2-SaO2 difference) using a carbon monoxide - blood gas analyzer (CO-oximeter) as reference.	30mins
Correlation analysis of parameters that have an impact on the accuracy of blood oxygen saturation of wearable devices.	When the test result is negative, evaluate the parameters that have an impact on the accuracy of blood oxygen saturation of wearable devices.	30mins
The variability of blood oxygen saturation of wearable devices tested three times.	Record the pulse oximetry and pulse rate values measured at the same time by the medical monitor and the Huami Smart Wearable Pulse Oximetry Device, respectively. After an interval of 30 seconds, repeat the above steps to start the second measurement and record the measured value. After an interval of 30 seconds, repeat the above steps to start the third measurement and record the measured value. Evaluate the variability of blood oxygen saturation of wearable devices tested three times.	30mins

Collaborators and Investigators

• Sponsor: Peking University First Hospital
• Collaborators: Anhui Huami Information Technology Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): May 29, 2020
• Primary Completion (Anticipated): June 30, 2020
• Study Completion (Anticipated): June 30, 2020

Study Registration Dates

• First Submitted: June 4, 2020
• First Submitted That Met QC Criteria: June 10, 2020
• First Posted (Actual): June 12, 2020

Study Record Updates

• Last Update Posted (Actual): June 12, 2020
• Last Update Submitted That Met QC Criteria: June 10, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Oxygen saturation Smart wearable device Accuracy
• Other Study ID Numbers: 2020114-0604

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No