Diagnostic Study of Huami Smart Wearable Device

NCT04429906 | Unknown DMC

• 1 other identifier: 2020114-0604
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Oxygen Saturation

Keywords

Oxygen saturation Smart wearable device Accuracy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Wearable device blood oxygen saturation accuracy Arms

  30mins

• Accuracy of blood oxygen saturation of wearable devices when SpO2/SaO2 is at 90%-100%.

  30mins

• Accuracy of blood oxygen saturation of wearable devices when SpO2/SaO2 is at 80%-89%.

  30mins

• Correlation analysis of 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.

  30mins

Study Arms (3)

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

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.

Interventions

Huami smart wearable device 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.

test group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Peking University First Hospital: lead
• Anhui Huami Information Technology Co., Ltd.: collaborator

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

RECRUITING

Related Publications (1)

• Olsen M, Zeitzer JM, Richardson RN, Davidenko P, Jennum PJ, Sorensen HBD, Mignot E. A Flexible Deep Learning Architecture for Temporal Sleep Stage Classification Using Accelerometry and Photoplethysmography. IEEE Trans Biomed Eng. 2023 Jan;70(1):228-237. doi: 10.1109/TBME.2022.3187945. Epub 2022 Dec 26.

  PMID: 35786544 DERIVED

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor & MD.

Study Record Dates

• First Submitted: June 4, 2020
• First Posted: June 12, 2020
• Study Start: May 29, 2020
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: June 12, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)