Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06565702
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-15
Brief Title:
Clinical Trial on the Accuracy of Blood Pressure Measurement by YE990 Medical Automatic Electronic Sphygmomanometer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Clinical Trial on the Accuracy of Blood Pressure Measurement by YE990 Medical Automatic Electronic Sphygmomanometer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 subjectsinclusion of 85 subjects aged 12 years or older who met the enrollment criteriaIn accordance with the Association for the Advancement of Medical InstrumentationEuropean Society of HypertensionInternational Organization for Standardization AAMIESHISO Universal Standard ISO 81060-22018Amd 12020the 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
Detailed Description:
This study was a single-center open-ended self-controlled clinical study Same armsequential method was used to measure the blood pressure of the subjectsinclusion of 85 subjects aged 12 years or older who met the enrollment criteriaIn accordance with the AAMIESHISO Universal Standard ISO 81060-22018Amd 12020the 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
One criteria for admission Inclusion Criteria
Subjects should meet all of the following requirements for inclusion in the study
1 Both sexes at least 30 of the subjects are male and at least 30 of the subjects are female
2 Subjects age 12 years
3 Arm circumference distribution
1 At least 20 of the subjects should have arm circumference within each quarter interval of the total arm circumference range
2 At least 10 of the subjects should have arm circumference within the upper one-eighth interval of the total arm circumference range
3 At least 10 of the subjects shall have an arm circumference within the lower one-eighth interval of the total arm circumference range
4 Blood pressure distribution
1 At least 5 of subjects shall have a systolic blood pressure 100 mmHg 1333 kPa
2 At least 5 of subjects shall have a systolic blood pressure 160 mmHg 2133 kPa
3 At least 20 of subjects should have a systolic blood pressure 140 mmHg 1866 kPa
4 Diastolic blood pressure should be 60 mmHg 80 kPa in at least 5 of subjects
5 Diastolic blood pressure should be 100 mmHg 1333 kPa in at least 5 of subjects f At least 20 of subjects should have a diastolic blood pressure 85 mmHg 1133 kPa
5 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 6 Good compliance and ability to complete the clinical trial 2 Exclusion Criteria
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
TwoEvaluation methods 21 Evaluation of effectiveness According to the standard requirements of AAMIESHISO Universal Standard ISO 81060-22018Amd 12020 the relationship between the mean value of the error and the standard deviation the consistency between the measured and reference blood pressure values and the relationship between the arm circumference and the measurement error should be evaluated
1 Error mean and standard deviation Calculate the mean and standard deviation of the difference ie error between the measured and reference blood pressure values and the result shall meet the requirements of ISO 81060-22018Amd 12020 5412
2 Agreement between measured and reference blood pressure values Bland-Altman analysis For each measurement position a scatter plot of the difference between the investigator and the device under test is obtained for each comparison of the investigator and the device under test and the values of systolic and diastolic blood pressures shall be plotted separately
3 Relationship between arm circumference and measurement error Bland-Altman analysis The relationship between upper arm circumference and measurement error is shown by plotting a scatter plot
4 Relative pulse rate error Descriptive statistics of relative error in pulse rate
22 Safety evaluation According to the Code for Quality Management of Clinical Trials of Medical Devices 2022 iii medical devices should be collected and recorded when conducting clinical trials
When conducting clinical trials of medical devices the occurrence of adverse events and defects of the devices in the course of use by the subjects should be collected and recorded
1 Incidence of adverse events
2 Incidence of device defects
23 Evaluation of product performance Clinical use performance evaluation is mainly for product stability evaluation the specific evaluation criteria are as follows the following items if evaluation
If the evaluation of the following items is yes it is necessary to specifically describe the cause of the failure
Evaluation item 1 electronic sphygmomanometer power on and off Yes Cannot be turned on andor off normally No can be turned on and off normally Evaluation Item II Whether the device automatically shuts off during the checking process Yes Automatic shutdown during the inspection No There is no automatic shutdown during the inspection Evaluation item 3 Whether there is any abnormal interruption due to the machine during the inspection process
Yes Abnormal interruptions occurred during the inspection process due to the machine No No abnormal interruptions occurred during the inspection Evaluation item 4 Whether inflation and exhaust failures occurred during the inspection process Yes Inflation andor exhaust failure occurred during the inspection No No inflation and exhaust failure occurred during the inspection Evaluation item 5 Whether air leakage occurred during the inspection process Yes Air leakage occurred No no air leakage occurred
ThreeTest medical device and control medical device
1 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
2 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
Fourstatistical analysis
1 General principles Descriptive statistical analysis qualitative indicators are described by frequency tables and percentages quantitative indicators are described by mean standard deviation minimum median maximum upper quartile Q1 and lower quartile Q3
2 Content of statistical analysis
1 The number of subjects enrolled dislodged and completed cases and a list of reasons why subjects withdrew from the study
2 Demographic and vital sign data of the subjects Quantitative data were analyzed by describing their number of cases mean standard deviation minimum median maximum and upper quartile
maximum upper quartile Q1 and lower quartile Q3 qualitative data were analyzed by describing the number of cases and their proportion of the total number of subjects
The qualitative data were analyzed by describing the number of cases and their percentages
3 Validity analysis Error mean and standard deviation According to ISO 81060-22018Amd 12020 5412 the error mean and standard deviation deviation should meet the following evaluation criteria Criterion 1 Calculate the mean and standard deviation of the errors of the 255 groups of measured and reference blood pressure values for 85 subjects
Criterion 1 Calculate the mean and standard deviation of the errors of 255 sets of measured and reference blood pressure values of 85 subjects and compare the systolic and diastolic blood pressures separately with the mean value of the error not exceeding 5 mmHg and the standard deviation not exceeding 8 mmHg
Criterion 2 Comparison of the mean of the three sets of errors for each subject comparing systolic and diastolic blood pressures separately
Agreement between measured and reference blood pressure values Bland-Altman analysis According to ISO 81060-22018Amd 12020 a scatter plot of the difference between the reference device and the device under test should be plotted for each occasion and the difference between systolic and diastolic blood pressure should be plotted separately x-axis indicates the mean value of the 2 methods of measurement for each subject and y-axis indicates the difference between the 2 methods of measurement for each subject
Relationship between arm circumference and measurement error Bland-Altman analysis Plot the results of all subjects by arm circumference according to ISO 81060-22018Amd 12020 514 d The x-axis shows the actual arm circumference of the subject and the y-axis shows the difference between the measured blood pressure value and the reference blood pressure value
Pulse Rate Error The relative error of the pulse rate measurement is counted
One criteria for admission Inclusion Criteria
Subjects should meet all of the following requirements for inclusion in the study
1 Both sexes at least 30 of the subjects are male and at least 30 of the subjects are female
2 Subjects age 12 years
3 Arm circumference distribution
1 At least 20 of the subjects should have arm circumference within each quarter interval of the total arm circumference range
2 At least 10 of the subjects should have arm circumference within the upper one-eighth interval of the total arm circumference range
3 At least 10 of the subjects shall have an arm circumference within the lower one-eighth interval of the total arm circumference range
4 Blood pressure distribution
1 At least 5 of subjects shall have a systolic blood pressure 100 mmHg 1333 kPa
2 At least 5 of subjects shall have a systolic blood pressure 160 mmHg 2133 kPa
3 At least 20 of subjects should have a systolic blood pressure 140 mmHg 1866 kPa
4 Diastolic blood pressure should be 60 mmHg 80 kPa in at least 5 of subjects
5 Diastolic blood pressure should be 100 mmHg 1333 kPa in at least 5 of subjects f At least 20 of subjects should have a diastolic blood pressure 85 mmHg 1133 kPa
5 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 6 Good compliance and ability to complete the clinical trial 2 Exclusion Criteria
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
TwoEvaluation methods 21 Evaluation of effectiveness According to the standard requirements of AAMIESHISO Universal Standard ISO 81060-22018Amd 12020 the relationship between the mean value of the error and the standard deviation the consistency between the measured and reference blood pressure values and the relationship between the arm circumference and the measurement error should be evaluated
1 Error mean and standard deviation Calculate the mean and standard deviation of the difference ie error between the measured and reference blood pressure values and the result shall meet the requirements of ISO 81060-22018Amd 12020 5412
2 Agreement between measured and reference blood pressure values Bland-Altman analysis For each measurement position a scatter plot of the difference between the investigator and the device under test is obtained for each comparison of the investigator and the device under test and the values of systolic and diastolic blood pressures shall be plotted separately
3 Relationship between arm circumference and measurement error Bland-Altman analysis The relationship between upper arm circumference and measurement error is shown by plotting a scatter plot
4 Relative pulse rate error Descriptive statistics of relative error in pulse rate
22 Safety evaluation According to the Code for Quality Management of Clinical Trials of Medical Devices 2022 iii medical devices should be collected and recorded when conducting clinical trials
When conducting clinical trials of medical devices the occurrence of adverse events and defects of the devices in the course of use by the subjects should be collected and recorded
1 Incidence of adverse events
2 Incidence of device defects
23 Evaluation of product performance Clinical use performance evaluation is mainly for product stability evaluation the specific evaluation criteria are as follows the following items if evaluation
If the evaluation of the following items is yes it is necessary to specifically describe the cause of the failure
Evaluation item 1 electronic sphygmomanometer power on and off Yes Cannot be turned on andor off normally No can be turned on and off normally Evaluation Item II Whether the device automatically shuts off during the checking process Yes Automatic shutdown during the inspection No There is no automatic shutdown during the inspection Evaluation item 3 Whether there is any abnormal interruption due to the machine during the inspection process
Yes Abnormal interruptions occurred during the inspection process due to the machine No No abnormal interruptions occurred during the inspection Evaluation item 4 Whether inflation and exhaust failures occurred during the inspection process Yes Inflation andor exhaust failure occurred during the inspection No No inflation and exhaust failure occurred during the inspection Evaluation item 5 Whether air leakage occurred during the inspection process Yes Air leakage occurred No no air leakage occurred
ThreeTest medical device and control medical device
1 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
2 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
Fourstatistical analysis
1 General principles Descriptive statistical analysis qualitative indicators are described by frequency tables and percentages quantitative indicators are described by mean standard deviation minimum median maximum upper quartile Q1 and lower quartile Q3
2 Content of statistical analysis
1 The number of subjects enrolled dislodged and completed cases and a list of reasons why subjects withdrew from the study
2 Demographic and vital sign data of the subjects Quantitative data were analyzed by describing their number of cases mean standard deviation minimum median maximum and upper quartile
maximum upper quartile Q1 and lower quartile Q3 qualitative data were analyzed by describing the number of cases and their proportion of the total number of subjects
The qualitative data were analyzed by describing the number of cases and their percentages
3 Validity analysis Error mean and standard deviation According to ISO 81060-22018Amd 12020 5412 the error mean and standard deviation deviation should meet the following evaluation criteria Criterion 1 Calculate the mean and standard deviation of the errors of the 255 groups of measured and reference blood pressure values for 85 subjects
Criterion 1 Calculate the mean and standard deviation of the errors of 255 sets of measured and reference blood pressure values of 85 subjects and compare the systolic and diastolic blood pressures separately with the mean value of the error not exceeding 5 mmHg and the standard deviation not exceeding 8 mmHg
Criterion 2 Comparison of the mean of the three sets of errors for each subject comparing systolic and diastolic blood pressures separately
Agreement between measured and reference blood pressure values Bland-Altman analysis According to ISO 81060-22018Amd 12020 a scatter plot of the difference between the reference device and the device under test should be plotted for each occasion and the difference between systolic and diastolic blood pressure should be plotted separately x-axis indicates the mean value of the 2 methods of measurement for each subject and y-axis indicates the difference between the 2 methods of measurement for each subject
Relationship between arm circumference and measurement error Bland-Altman analysis Plot the results of all subjects by arm circumference according to ISO 81060-22018Amd 12020 514 d The x-axis shows the actual arm circumference of the subject and the y-axis shows the difference between the measured blood pressure value and the reference blood pressure value
Pulse Rate Error The relative error of the pulse rate measurement is counted
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None