Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06609486
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-20
Brief Title:
Clinical Evaluation of the Performance of Bionet Sphygmomanometer Modules Based on Protocol Presented by the International Organization for Standardization
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Clinical Evaluation of Bionet Sphygmomanometer Module BN1 Based on ISO 81060-22018 Protocol
Status:
COMPLETED
Status Verified Date:
2024-09
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:
According to INTERNATIONAL STANDARD hereafter ISO blood pressure BP monitor clinical evaluation protocol ISO 81060-22018 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
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 81060-22018 so one dropout data pair total of three dropout data pairs occurred Therefore 255 valid data pairs were obtained from 86 study subjects and the distribution conditions required by ISO 81060-22018 were satisfied
Criterion 1 is that for 255 valid data pairs the average value of the difference between the test medical device and the auscultation method blood pressure should be 5 mmHg or less and the standard deviation should be 8 mmHg or less In this study systolic blood pressure SBP was -155625 mmHg and diastolic blood pressure DBP was -002661 mmHg confirming that Criterion 1 was satisfied
Criterion 2 is that for 86 study subjects the standard deviation of the average value of the difference between the data pairs of each study subject must satisfy the standard deviation criterion according to the average value of the blood pressure difference provided by ISO 81060-22018 The mean value of the difference in blood pressure in this study was SBP -16 mmHg and DBP -00 mmHg and the standard deviation should be less than SBP 676 mmHg and DBP 695 mmHg respectively In this study it was confirmed that the standard deviation satisfies Criterion 2 with SBP 497 mmHg and DBP 582 mmHg
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
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 81060-22018 so one dropout data pair total of three dropout data pairs occurred Therefore 255 valid data pairs were obtained from 86 study subjects and the distribution conditions required by ISO 81060-22018 were satisfied
Criterion 1 is that for 255 valid data pairs the average value of the difference between the test medical device and the auscultation method blood pressure should be 5 mmHg or less and the standard deviation should be 8 mmHg or less In this study systolic blood pressure SBP was -155625 mmHg and diastolic blood pressure DBP was -002661 mmHg confirming that Criterion 1 was satisfied
Criterion 2 is that for 86 study subjects the standard deviation of the average value of the difference between the data pairs of each study subject must satisfy the standard deviation criterion according to the average value of the blood pressure difference provided by ISO 81060-22018 The mean value of the difference in blood pressure in this study was SBP -16 mmHg and DBP -00 mmHg and the standard deviation should be less than SBP 676 mmHg and DBP 695 mmHg respectively In this study it was confirmed that the standard deviation satisfies Criterion 2 with SBP 497 mmHg and DBP 582 mmHg
Detailed Description:
None
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