Ignite Creation Date:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2025-12-26 @ 11:00 AM
Study NCT ID:
NCT04429906
Status:
UNKNOWN
Last Update Posted:
2020-06-12
First Post:
2020-06-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Diagnostic Study of Huami Smart Wearable Device
Sponsor:
Peking University First Hospital
Organization:
Study Overview
Official Title:
Evaluation of Accuracy of Blood Oxygen Saturation Detection Function of Huami Smart Wearable Device
Status:
UNKNOWN
Status Verified Date:
2020-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DSHWD
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: