Validation Study of CONTEC08C Electronic Sphygmomanometer

Chinese Academy of Medical Sciences, Fuwai Hospital

Status: Enrolling

Conditions: Blood Pressure

Treatments: Diagnostic Test: Blood pressure measurement

Study type: Interventional

Funder types: Other

Identifiers

NCT06457568

2023-ZX082

Details and patient eligibility

About

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).

Enrollment: 100 estimated patients

Sex: All

Ages: 12 to 79 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

CONTEC08C and mercury sphygmomanometer

Experimental group

Description:

Blood Pressure Measurement with the CONTEC08C Oscillometric Sphygmomanometer (CONTEC08C) and with Mercury Sphygmomanometer

Treatment:

Diagnostic Test: Blood pressure measurement