NCT06457568RecruitingNot Applicable
Validation of the CONTEC08C Oscillometric Blood Pressure Monitor in General Population According to the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018)
Chinese Academy of Medical Sciences, Fuwai Hospital1 site in 1 country100 target enrollmentStarted: May 25, 2024Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Blood pressure measurement data
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 12 Years to 79 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
Blood pressure measurement data
Time Frame: 30mintues
Systolic Blood Pressure and Diastolic Blood Pressure
Secondary Outcomes
No secondary outcomes reported
Investigators
Lou ying
MD
Chinese Academy of Medical Sciences, Fuwai Hospital
Study Sites (1)
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