Validation Study of CONTEC08C Electronic Sphygmomanometer

Blood Pressure Clinical Trial

Official title:

Validation of the CONTEC08C Oscillometric Blood Pressure Monitor in General Population According to the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06457568
• Other study ID #: 2023-ZX082
• Status: Recruiting
• Phase: N/A
• Start date: May 25, 2024
• Est. completion date: August 1, 2024

Study information

• Verified date: May 2024
• Source: Chinese Academy of Medical Sciences, Fuwai Hospital
• Contact: Ying Lou, MD
• Phone: 86(10)88392170
• Email: fuwailou1798[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 1, 2024
• Est. primary completion date: July 25, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 79 Years

Eligibility

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.

Related Conditions & MeSH terms

• Blood Pressure

Intervention

Diagnostic Test:
• Blood pressure measurement
The blood pressure measurement was taken simultaneously by two observers using mercury sphygmomanometers and by a supervisor using the tested device, CONTEC08C.

Locations

Country	Name	City	State
China	Chinese Academy of Medical Sciences,Fuwai Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences, Fuwai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood pressure measurement data	Systolic Blood Pressure and Diastolic Blood Pressure	30mintues