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| Name | Class |
|---|---|
| Bionet Co., Ltd | INDUSTRY |
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According to INTERNATIONAL STANDARD (hereafter ISO) blood pressure (BP) monitor clinical evaluation protocol (ISO 81060-2:2018, Non-invasive sphygmomanometers- Part2: Clinical investigation of intermittent automated measurement type) for BN1 (BNiBP), an electronic sphygmomanometer module newly developed by Bionet Co., Ltd., the clinical group and evaluation criteria presented in, the effectiveness of blood pressure measurement performance was evaluated.
The auscultation method used as a reference (gold standard) of a non-invasive blood pressure (NIBP) measurement method was used. The first blood pressure measurement was performed once each (reference BP not used for evaluation, R0; test BP not used for evaluation, T0) with auscultation and the test medical device (BM5 equipped with BN1 (BNiBP)). The blood pressure used for evaluation was measured four times by auscultation (first reference BP to fourth reference BP, R1 to R4) and three times by the test medical device (first test BP to third test BP, T1 to T3) alternately. A minimum interval of 1 min was allowed between each blood pressure measurement.
Three data pairs (mean value of R1, R2 & T1 / R2, mean value of R3 & T2 / R3, mean value of R4 & T3) were obtained from one study subject. This study aims to verify that the mean value of the differences and standard deviations of data pairs meet the criteria of ISO 81060-2:2018.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blood pressure measurement group | Experimental | In this study, the protocol applied to automatic electronic blood pressure system module BN1 for performance evaluation is ISO's proposed "ISO 81060-2:2018 Non-invasive sphygmomanometers- Part2: Clinical investment of internal automatic measurement type". The initial BP measurement is performed alternately, measuring the blood pressure by the measurer and the test device once each, and measuring blood pressure by the measurer four times by the observer and three times by the test device. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood pressure measurement group | Device | In this study, the protocol applied to automatic electronic blood pressure system module BN1 for performance evaluation is ISO's proposed "ISO 81060-2:2018 Non-invasive sphygmomanometers- Part2: Clinical investment of internal automatic measurement type". The initial BP measurement is performed alternately, measuring the blood pressure by the measurer and the test device once each, and measuring blood pressure by the measurer four times by the observer and three times by the test device. |
| Measure | Description | Time Frame |
|---|---|---|
| Test Device's Blood Pressure of Resting Condition | The blood pressure used for evaluation was measured four times by auscultation (first reference BP to fourth reference BP, R1 to R4) and three times by the test medical device (first test BP to third test BP, T1 to T3) alternately. A minimum interval of 1 min was allowed between each BP measurement. Three data pairs (mean value of R1, R2 & T1 / R2, mean value of R3 & T2 / R3, mean value of R4 & T3) were obtained from one study subject. Criterion 1 is that for valid data pairs, the mean value of the difference between the test medical device and the auscultation method BP (test device BP - auscultation BP) should be 5 mmHg or less and the standard deviation (SD) should be 8 mmHg or less. Criterion 2 is that, for study subjects, the ISO 81060-2:2018 for presenting different SD thresholds depending on the mean value of the difference should be satisfied. When mean value of the difference is ±1.6, ±0.0 mmHg, the SD should be less than 6.76 and 6.95 mmHg, respectively. | Right after the experiment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hoon-Ki Park, M.D., Ph.D. | Department of Family Medicine, Hanyang University Seoul Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hanyang University Seoul Hospital | Seoul | 04763 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17890975 | Background | Alpert BS. Validation of the Welch Allyn Spot Vital Signs blood pressure device according to the ANSI/AAMI SP10: 2002. Accuracy and cost-efficiency successfully combined. Blood Press Monit. 2007 Oct;12(5):345-7. doi: 10.1097/MBP.0b013e3282c9abf7. | |
| 16410738 | Background | Coleman A, Freeman P, Steel S, Shennan A. Validation of the Omron 705IT (HEM-759-E) oscillometric blood pressure monitoring device according to the British Hypertension Society protocol. Blood Press Monit. 2006 Feb;11(1):27-32. doi: 10.1097/01.mbp.0000189788.05736.5f. |
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[Selection Criteria] - Subjects who have consented to participate in the clinical trial and voluntarily consented in writing - Subjects who meet the criteria presented in ISO 81060-2:2018 Protocol 5.1 Subject requirements [Items excluded from clinical trials] - Complete blood pressure range recruitment (Range complete) - Arrhythmia - Device failure - Cuff size unavailable - Poor quality of Korotkoff sounds - Observers disagreement - Other factors
Recruitment is made through the recruitment notice for patients and their guardians who visit Hanyang University Hospital. Subjects who meet the criteria presented in ISO 81060-2:2018 Protocol 5.1 Subject requirements are recruited.
| ID | Title | Description |
|---|---|---|
| FG000 | Blood Pressure Measurement Group | In this study, the protocol applied to automatic electronic blood pressure system module BN1 for performance evaluation is ISO's proposed "ISO 81060-2:2018 Non-invasive sphygmomanometers- Part2: Clinical investment of internal automatic measurement type". The initial BP measurement is performed alternately, measuring the blood pressure by the measurer and the test device once each, and measuring blood pressure by the measurer four times by the observer and three times by the test device. A total of 86 study subjects were enrolled. Three data pairs (mean value of R1, R2 & T1 / R2, mean value of R3 & T2 / R3, mean value of R4 & T3) were obtained from one study subject, and a total of 258 data pairs were obtained. Among them, some data of three study subjects did not satisfy the conditions required by ISO 81060-2:2018, so one dropout data pair (total of three dropout data pairs) occurred. Therefore, 255 valid data pairs were obtained from 86 study subjects. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 7, 2020 |
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In this study, the protocol applied to automatic electronic blood pressure system module BN1 for performance evaluation is ISO's proposed "ISO 81060-2:2018 Non-invasive sphygmomanometers- Part2: Clinical investment of internal automatic measurement type". The initial BP measurement is performed alternately, measuring the blood pressure by the measurer and the test device once each, and measuring blood pressure by the measurer four times by the observer and three times by the test device.
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In this study, the protocol applied to automatic electronic blood pressure system module BN1 for performance evaluation is ISO's proposed "ISO 81060-2:2018 Non-invasive sphygmomanometers- Part2: Clinical investment of internal automatic measurement type". The initial BP measurement is performed alternately, measuring the blood pressure by the measurer and the test device once each, and measuring blood pressure by the measurer four times by the observer and three times by the test device.
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| Background | Guidelines for Accuracy Evaluation of Electronic Sphygmomanometers - KFDA Food and Drug Administration |
| 20110786 | Background | O'Brien E, Atkins N, Stergiou G, Karpettas N, Parati G, Asmar R, Imai Y, Wang J, Mengden T, Shennan A; Working Group on Blood Pressure Monitoring of the European Society of Hypertension. European Society of Hypertension International Protocol revision 2010 for the validation of blood pressure measuring devices in adults. Blood Press Monit. 2010 Feb;15(1):23-38. doi: 10.1097/MBP.0b013e3283360e98. No abstract available. |
| 29384983 | Background | Stergiou GS, Alpert B, Mieke S, Asmar R, Atkins N, Eckert S, Frick G, Friedman B, Grassl T, Ichikawa T, Ioannidis JP, Lacy P, McManus R, Murray A, Myers M, Palatini P, Parati G, Quinn D, Sarkis J, Shennan A, Usuda T, Wang J, Wu CO, O'Brien E. A universal standard for the validation of blood pressure measuring devices: Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Collaboration Statement. J Hypertens. 2018 Mar;36(3):472-478. doi: 10.1097/HJH.0000000000001634. |
| Background | International Organization for Standardization. Noninvasive sphygmomanometers: part 2: clinical investigation of intermittent automated measurement type. (2018): 36. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Blood Pressure Measurement Group | In this study, the protocol applied to automatic electronic blood pressure system module BN1 for performance evaluation is ISO's proposed "ISO 81060-2:2018 Non-invasive sphygmomanometers- Part2: Clinical investment of internal automatic measurement type". The initial BP measurement is performed alternately, measuring the blood pressure by the measurer and the test device once each, and measuring blood pressure by the measurer four times by the observer and three times by the test device. Blood pressure measurement group: In this study, the protocol applied to automatic electronic blood pressure system module BN1 for performance evaluation is ISO's proposed "ISO 81060-2:2018 Non-invasive sphygmomanometers- Part2: Clinical investment of internal automatic measurement type". The initial BP measurement is performed alternately, measuring the blood pressure by the measurer and the test device once each, and measuring blood pressure by the measurer four times by the observer and three times by the test device. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
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| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Test Device's Blood Pressure of Resting Condition | The blood pressure used for evaluation was measured four times by auscultation (first reference BP to fourth reference BP, R1 to R4) and three times by the test medical device (first test BP to third test BP, T1 to T3) alternately. A minimum interval of 1 min was allowed between each BP measurement. Three data pairs (mean value of R1, R2 & T1 / R2, mean value of R3 & T2 / R3, mean value of R4 & T3) were obtained from one study subject. Criterion 1 is that for valid data pairs, the mean value of the difference between the test medical device and the auscultation method BP (test device BP - auscultation BP) should be 5 mmHg or less and the standard deviation (SD) should be 8 mmHg or less. Criterion 2 is that, for study subjects, the ISO 81060-2:2018 for presenting different SD thresholds depending on the mean value of the difference should be satisfied. When mean value of the difference is ±1.6, ±0.0 mmHg, the SD should be less than 6.76 and 6.95 mmHg, respectively. | A total of 86 study subjects were enrolled. Three data pairs (mean value of R1, R2 & T1 / R2, mean value of R3 & T2 / R3, mean value of R4 & T3) were obtained from one study subject, and a total of 258 data pairs were obtained. Among them, some data of three study subjects did not satisfy the conditions required by ISO 81060-2:2018, so one dropout data pair (total of three dropout data pairs) occurred. Therefore, 255 valid data pairs were obtained from 86 study subjects. | Posted | Mean | Standard Deviation | mmHg | Right after the experiment | Data pair | Data pair |
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All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Blood Pressure Measurement Group | In this study, the protocol applied to automatic electronic blood pressure system module BN1 for performance evaluation is ISO's proposed "ISO 81060-2:2018 Non-invasive sphygmomanometers- Part2: Clinical investment of internal automatic measurement type". The initial BP measurement is performed alternately, measuring the blood pressure by the measurer and the test device once each, and measuring blood pressure by the measurer four times by the observer and three times by the test device. A total of 86 study subjects were enrolled. Three data pairs (mean value of R1, R2 & T1 / R2, mean value of R3 & T2 / R3, mean value of R4 & T3) were obtained from one study subject, and a total of 258 data pairs were obtained. Among them, some data of three study subjects did not satisfy the conditions required by ISO 81060-2:2018, so one dropout data pair (total of three dropout data pairs) occurred. Therefore, 255 valid data pairs were obtained from 86 study subjects. | 0 | 0 | 0 | 0 | 0 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jongshill Lee, Ph.D. | Hanyang University Seoul Hospital | +82-10-6209-4260 | netlee@hanyang.ac.kr |
| Sep 30, 2024 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D007022 | Hypotension |
| D006973 | Hypertension |
| D058246 | Prehypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| >=65 years |
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| Title | Measurements |
|---|---|
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| Criterion 2 (DBP) |
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