Validation Study of CONTEC08C Electronic Sphygmomanometer
Not Applicable
Recruiting
- Conditions
- Blood Pressure
- Interventions
- Diagnostic Test: Blood pressure measurement
- Registration Number
- NCT06457568
- Lead Sponsor
- Chinese Academy of Medical Sciences, Fuwai Hospital
- Brief Summary
The purpose of this study is to assess the accuracy of the CONTEC08C automated oscillometric upper-arm sphygmomanometer in the general population for clinical use 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
- Subjects aged 12 to 79 years
- Subjects voluntarily participate in the clinical trial and sign the informed consent.
Exclusion Criteria
- Subjects with cardiac arrhythmias;
- Pregnancy;
- Poor quality Korotkoff sounds;
- Subject with an arm injury incompatible with the use of a cuff-based sphygmomanometer;
- Other conditions that the investigator considers ineligible for clinical trial.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description CONTEC08C and mercury sphygmomanometer Blood pressure measurement Blood Pressure Measurement with the CONTEC08C Oscillometric Sphygmomanometer (CONTEC08C) and with Mercury Sphygmomanometer
- Primary Outcome Measures
Name Time Method Blood pressure measurement data 30mintues Systolic Blood Pressure and Diastolic Blood Pressure
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Chinese Academy of Medical Sciences，Fuwai Hospital
🇨🇳Beijing, Beijing, China