Validation of the YuWell YE900 Medical Electronic Blood Pressure Monitor in Adults and Children According to the AAMI/ESH/ISO 81060-2:2018 Standard
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 92
- Locations
- 1
- Primary Endpoint
- Blood pressure measurement data
Study Overview
Brief Summary
The purpose of this study is to evaluate the accuracy of the YuWell YE900 medical electronic blood pressure monitor for blood pressure measurements in adults and children according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Universal Standard (ISO 81060-2:2018).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 3 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •3 Years and older (Child, Adult, Older Adult);
- •Subjects voluntarily participate in the clinical trial and sign the informed consent.
Exclusion Criteria
- •Disturbance of consciousness;
- •Patients requiring hemodialysis;
- •Taking anticoagulant drugs due to cardiovascular and cerebrovascular diseases;
- •Pregnant and lactating women;
- •Patients with cardiac arrhythmias;
- •Other conditions that the investigator considers ineligible for clinical trial.
Arms & Interventions
YuWell YE900 and mercury sphygmomanometer
Blood Pressure Measurement with the YuWell YE900 Electronic Sphygmomanometer (YuWell YE900) and with Desk Mercury Sphygmomanometer.
Intervention: YuWell YE900 Electronic Sphygmomanometer (Diagnostic Test)
Outcomes
Primary Outcomes
Blood pressure measurement data
Time Frame: 30 minutes
Systolic Pressure and Diastolic Pressure
Secondary Outcomes
No secondary outcomes reported
Investigators
zhang Hui Jie
Director of Clinical trial center
The Second Hospital of Nanjing Medical University