Blood Pressure
Conditions
Keywords
Hypotension, Hypertension, Prehypertension, Sphygmomanometers
Brief summary
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.
Interventions
DEVICEBlood 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.
Sponsors
Bionet Co., Ltd
Hoon-Ki Park
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
3 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* Emergency surgery patient * Persons who have mental disorders such as mental retardation, autism, etc. and who have difficulty measuring blood pressure or are expected to have difficulties * A person who disagreed with the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Test Device's Blood Pressure of Resting Condition | Right after the experiment | 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. |
Countries
South Korea
Participant flow
Recruitment details
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.
Pre-assignment details
\[Selection Criteria\] - 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
Participants by arm
| Arm | Count |
|---|---|
| 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. | 86 |
| Total | 86 |
Baseline characteristics
| Characteristic | Blood Pressure Measurement Group | — |
|---|---|---|
| Age, Categorical <=18 years | 41 Participants | — |
| Age, Categorical >=65 years | 1 Participants | — |
| Age, Categorical Between 18 and 65 years | 44 Participants | — |
| Age, Continuous | 23 years STANDARD_DEVIATION 18.65 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment South Korea | 86 participants | — |
| Sex: Female, Male Female | 37 Participants | — |
| Sex: Female, Male Male | 49 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
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.
Time frame: Right after the experiment
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Blood Pressure Measurement Group | Test Device's Blood Pressure of Resting Condition | Criterion 1 (SBP) | -1.55 mmHg | Standard Deviation 6.25 |
| Blood Pressure Measurement Group | Test Device's Blood Pressure of Resting Condition | Criterion 1 (DBP) | -0.02 mmHg | Standard Deviation 6.61 |
| Blood Pressure Measurement Group | Test Device's Blood Pressure of Resting Condition | Criterion 2 (SBP) | -1.6 mmHg | Standard Deviation 4.97 |
| Blood Pressure Measurement Group | Test Device's Blood Pressure of Resting Condition | Criterion 2 (DBP) | -0.0 mmHg | Standard Deviation 5.82 |