Validation Study of CONTEC08C Electronic Sphygmomanometer
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 Hospital
100 participants
May 25, 2024
INTERVENTIONAL
Conditions
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).
Eligibility
Inclusion Criteria2
- Subjects aged 12 to 79 years
- Subjects voluntarily participate in the clinical trial and sign the informed consent.
Exclusion Criteria5
- 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.
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Interventions
The blood pressure measurement was taken simultaneously by two observers using mercury sphygmomanometer and by a supervisor using the tested device, CONTEC08C.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06457568