Clinical Trial of YuWell YE900 Electronic Sphygmomanometer

Nanjing Medical University

Status: Completed

Conditions: Blood Pressure

Treatments: Diagnostic Test: YuWell YE900 Electronic Sphygmomanometer

Study type: Interventional

Funder types: Other

Identifiers

NCT04379323

YUWELL-YLQX202001

Details and patient eligibility

About

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).

Enrollment: 92 patients

Sex: All

Ages: 3+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. 3 Years and older (Child, Adult, Older Adult);
2. Subjects voluntarily participate in the clinical trial and sign the informed consent.

Exclusion criteria

1. Disturbance of consciousness;
2. Patients requiring hemodialysis;
3. Taking anticoagulant drugs due to cardiovascular and cerebrovascular diseases;
4. Pregnant and lactating women;
5. Patients with cardiac arrhythmias;
6. Other conditions that the investigator considers ineligible for clinical trial.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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92 participants in 1 patient group

YuWell YE900 and mercury sphygmomanometer

Experimental group

Description:

Blood Pressure Measurement with the YuWell YE900 Electronic Sphygmomanometer (YuWell YE900) and with Desk Mercury Sphygmomanometer.

Treatment:

Diagnostic Test: YuWell YE900 Electronic Sphygmomanometer