UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054422 |
|---|---|
| Receipt number | R000062162 |
| Scientific Title | Verification of the effect of cuff wrapping on measured values when measuring blood pressure using auscultation method |
| Date of disclosure of the study information | 2024/05/20 |
| Last modified on | 2024/05/21 11:38:37 |
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Basic information
Public title
Verification of the effect of cuff wrapping on measured values when measuring blood pressure using auscultation method
Acronym
Verification of the effect of cuff wrapping on measured values when measuring blood pressure using auscultation method
Scientific Title
Verification of the effect of cuff wrapping on measured values when measuring blood pressure using auscultation method
Scientific Title:Acronym
Verification of the effect of cuff wrapping on measured values when measuring blood pressure using auscultation method
Region
| Japan |
Condition
Condition
none
Classification by specialty
| Cardiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study examines the influence of the way the cuff is wrapped on the measured values when measuring blood pressure using the auscultation method.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Differences in measured values depending on how the cuff is wrapped when measuring blood pressure using auscultation method
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Subjects with arm circumference of 17 cm or more and 42 cm or less
2. Subjects aged 18 years or older
3.Subjects who understand the test content and have given written informed consent
Key exclusion criteria
1) Subjects who cannot consent to participate in the study
2) Subjects who have skin problems on their upper arms and cannot measure blood pressure
3) Subjects requiring assistance (subjects unable to walk independently)
4) Subjects with arrhythmia or pacemaker implantation
5) Subjects with diabetes or a history of cardiovascular disease
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | NOBORU |
| Middle name | |
| Last name | SHINOMIYA |
Organization
OMRON HEALTHCARE Co. Ltd.
Division name
TECHNOLOGY DEVELOPMENT HQ STRATEGIC CLINICAL R&D DEPARTMENT
Zip code
617-0002
Address
53, Kunotsubo, Terado-cho, Muko, Kyoto
TEL
050-1801-5158
noboru.shinomiya@omron.com
Public contact
Name of contact person
| 1st name | NOBUKI |
| Middle name | |
| Last name | YAKURA |
Organization
OMRON HEALTHCARE Co. Ltd.
Division name
TECHNOLOGY DEVELOPMENT HQ STRATEGIC CLINICAL R&D DEPARTMENT
Zip code
617-0002
Address
53, Kunotsubo, Terado-cho, Muko, Kyoto
TEL
050-1801-5158
Homepage URL
nobuki.yakura@omron.com
Sponsor or person
Institute
OMRON HEALTHCARE Co. Ltd.
Institute
Department
Personal name
NOBUKI YAKRUA
Funding Source
Organization
OMRON HEALTHCARE Co. Ltd.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
OMRON HEALTHCARE Examination Review Committee
Address
53, Kunotsubo, Terado-cho, Muko, Kyoto
Tel
075-925-2045
mitsunori.hara@omron.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 05 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 05 | Month | 07 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 07 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 08 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Personal information will be anonymized and the following data will be collected.
1. Blood pressure value by auscultation method
2. Pulse wave information/auscultation sound
3. Gender
4. Age
5. Height
6. Weight
7. Arm circumference
8. Whether or not the patient is taking antihypertensive drugs
Regarding the data collection in 1 and 2, we will compare and evaluate the error regarding the influence of the cuff wrapping method on the measurement accuracy using the auscultation method, using snug wrapping as the standard.
Loosen the top and bottom of the cuff based on the snugly wrapped position.
(1) Tightly rolled
(2) 1.0cm loosely rolled
(3) 2.0cm loosely rolled
For each subject, blood pressure measurements were performed using the auscultation method 8 times * 3 sets in order to obtain 3 sets of comparison data in (1), (2), and (3) above. Take a break of at least 10 minutes between each set. Also, blood pressure measurements within the set should be at least 1 minute apart. If body movement is confirmed, measurements will be taken up to 13 times for each set, but the maximum total number of measurements for 3 sets will be up to 30 times.
Data collection in 6 will be measured using a scale, and other data will be collected based on the subject's self-report.
Statistical analysis method:
Using the ISO81060-2 analysis method, calculate the average and standard deviation of the errors in blood pressure measurements when the reference (tightly wrapped) and the cuff are loosely wrapped.
Differences in measurement accuracy between measurement conditions are detected using a linear mixed model.
(The statistical significance level is 5.0% on both sides, and the power is 80%.)
Management information
Registered date
| 2024 | Year | 05 | Month | 17 | Day |
Last modified on
| 2024 | Year | 05 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062162
