Clinical Trial on the Accuracy of Blood Pressure Measurement by YE990 Medical Automatic Electronic Sphygmomanometer

NCT06565702 | Not Yet Recruiting DMC

• 1 other identifier: YC20240201
• Study Type: observational
• Target: 85
• Locations: 1 country
• Sites: 1

Brief Summary

This study was a single-center, open-ended, self-controlled clinical study . Same armsequential method was used to measure the blood pressure of the subjects，inclusion of ≥85 subjects aged 12 years or older who met the enrollment criteria.In accordance with 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/Amd 1:2020)",the purpose of this study was to compare the blood pressure and pulse rate measured by an electronic sphygmomanometer with those measured by a reference sphygmomanometer (an upper-arm noninvasive auscultatory sphygmomanometer) and by palpation of the radial artery, and then to evaluate the accuracy and safety of the measurement of systolic blood pressure, diastolic blood pressure, and pulse rate by a fully automated electronic sphygmomanometer for medical use (Model No. YE990), which is manufactured by Jiangsu Yuyue Medical Equipment Co.

Conditions

Blood Pressure

Keywords

accuracy; systolic blood pressure; diastolic blood pressure; pulse rate; 12 years of age or older; automatic electronic sphygmomanometers

Outcome Measures

Primary Outcomes (1)

• To evaluate the accuracy of the arm-type electronic blood pressure monitor (Model: YE660D) in measuring systolic blood pressure, diastolic blood pressure and pulse rate in adults aged 12 years and above.

  Evaluate the relationship between the mean and standard deviation of error, the agreement between the measured and reference blood pressure values, and the relationship between arm circumference and measurement error.Reference standard: 255 sets of data from 85 subjects were calculated and compared separately for systolic and diastolic blood pressure, with a mean deviation of not more than ±5 mmHg and a standard deviation of not more than 8 mmHg.

  August 20, 2024 - December 30, 2025

Secondary Outcomes (1)

• Collect and document the occurrence of adverse events and device defects in subjects during use

  August 20, 2024 - December 30, 2025

Other Outcomes (1)

• Clinical use performance evaluation is mainly product stability evaluation

  August 20, 2024 - December 30, 2025

Study Arms (2)

Test medical equipment (blood pressure monitor)

Name of device: Medical automatic electronic sphygmomanometer (Model: YE990) Registrant name: Jiangsu Yuyue Medical Equipment Co. Registration Certificate No.: Su Meizhi Quasi 20222071271 The minimum number of valid cases for the evaluation of the electronic sphygmomanometer with auscultation as a control, with sequential measurements in the same arm, was 85, of which 3 valid data sets were provided by each subject, for a total of 255 data sets.

Control medical devices (reference sphygmomanometer)

Name of device: Sphygmomanometer - stethoscope health care box (Model: A type) Registrant name: Jiangsu Yuyue Medical Equipment Co. Certificate of Registration No.: SuMeChiQi 20152070947 The minimum number of valid cases for the evaluation of the electronic sphygmomanometer with auscultation as a control, with sequential measurements in the same arm, was 85, of which 3 valid data sets were provided by each subject, for a total of 255 data sets.

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Healthy people over 12 years of age who meet the criteria for admission to the platoon

You may qualify if:

• Both sexes; at least 30% of the subjects are male and at least 30% of the subjects are female.
• Subject's age \> 12 years.
• Arm circumference distribution:
• At least 20% of the subjects should have arm circumference within each quarter interval of the total arm circumference range;
• At least 10% of the subjects should have arm circumference within the upper one-eighth interval of the total arm circumference range;
• At least 10% of the subjects shall have an arm circumference within the lower one-eighth interval of the total arm circumference range.
• Blood pressure distribution:
• At least 5% of subjects shall have a systolic blood pressure ≤100 mmHg (13.33 kPa);
• At least 5% of subjects shall have a systolic blood pressure ≥ 160 mmHg (21.33 kPa);
• At least 20% of subjects should have a systolic blood pressure ≥ 140 mmHg (18.66 kPa);
• Diastolic blood pressure should be ≤60 mmHg (8.0 kPa) in at least 5% of subjects;
• Diastolic blood pressure should be ≥100 mmHg (13.33 kPa) in at least 5% of subjects; (f) At least 20% of subjects should have a diastolic blood pressure ≥85 mmHg (11.33 kPa);
• Subjects must be willing and able to comply with the study procedures by signing an informed consent form after being informed about the study.
• consent form after understanding the contents of the study.
• Good compliance and ability to complete the clinical trial.

You may not qualify if:

• Subjects who fulfill any of the following requirements cannot be included in the study:
• (1) Mental illness, impaired consciousness, or other conditions that prevent them from cooperating with the study; (2) Require hemodialysis; (3) Taking anticoagulant drugs for cardiovascular diseases; (4) Pregnant and lactating women; (5) Patients with cardiac arrhythmia; (6) Patients with peripheral arterial disease and diseases that may affect arterial compliance; (7) Other conditions that are considered by the physician to be unsuitable for enrollment.

Sponsors & Collaborators

• The First Affiliated Hospital of Anhui Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Anhui Medical University Hospital

Hefei, Anhui, 230000, China

Location

Related Publications (1)

• Xu D, Tang H, Wang C, Cheng H, Wu W, Lu Q, Liu H. Validation of the YuWell YE990 medical automatic electronic blood pressure monitor according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization Universal Standard (ISO 81060-2:2018/Amd.1:2020). Blood Press Monit. 2025 Aug 1;30(4):191-195. doi: 10.1097/MBP.0000000000000755. Epub 2025 May 6.

  PMID: 40327332 DERIVED

Study Officials

• Hejun Liu

  The First Affiliated Hospital of Anhui Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hejun Liu

CONTACT

0511-86900833; hejun_liu123@163.com

Ji Nian Wang

CONTACT

252848602@qq.com

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician M.D., M.S.

Study Record Dates

• First Submitted: July 15, 2024
• First Posted: August 22, 2024
• Study Start: August 20, 2024
• Primary Completion: August 20, 2025
• Study Completion: December 30, 2025
• Last Updated: August 22, 2024

Record last verified: 2024-08

Locations

CN (1)