UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044594 |
|---|---|
| Receipt number | R000050935 |
| Scientific Title | Comparison of the non-invasive blood pressure with the invasive blood pressure using the Error Grid analysis in patients undergoing cardiovascular surgery |
| Date of disclosure of the study information | 2021/06/19 |
| Last modified on | 2021/06/19 17:29:21 |
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Basic information
Public title
Comparison of the non-invasive blood pressure with the invasive blood pressure using the Error Grid analysis in patients undergoing cardiovascular surgery
Acronym
Comparison of the non-invasive blood pressure with the invasive blood pressure using the Error Grid analysis in patients undergoing cardiovascular surgery
Scientific Title
Comparison of the non-invasive blood pressure with the invasive blood pressure using the Error Grid analysis in patients undergoing cardiovascular surgery
Scientific Title:Acronym
Comparison of the non-invasive blood pressure with the invasive blood pressure using the Error Grid analysis in patients undergoing cardiovascular surgery
Region
| Japan |
Condition
Condition
Patients undergoing cardiovascular surgery
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the non-invasive blood pressure with the invasive blood pressure using the Error Grid analysis in cardiovascular surgery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Non-invasive pressure and invasive blood pressure measured during surgery
Key secondary outcomes
Base
Study type
Observational
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients undergoing cardiovascular surgery
Key exclusion criteria
1. Emergency cases
2. Patients receiving hemodialysis
3. Patients having more than 10 mmHg differences in preoperative mean blood pressure between arms
4. Patients with preoperative atrial fibrillation
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Koichi |
| Middle name | |
| Last name | Suehiro |
Organization
Osaka City University Graduate School of Medicine
Division name
Department of Anesthesiology
Zip code
634-0063
Address
1-5-7 Asahimachi, Abeno-ku, Osaka 545-8586, Japan
TEL
06-6645-2186
suehirokoichi@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Koichi |
| Middle name | |
| Last name | Suehiro |
Organization
Osaka City University Graduate School of Medicine
Division name
Department of Anesthesiology
Zip code
634-0063
Address
1-5-7 Asahimachi, Abeno-ku, Osaka 545-8586, Japan
TEL
06-6645-2186
Homepage URL
suehirokoichi@yahoo.co.jp
Sponsor or person
Institute
Department of Anesthesiology
Osaka City University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Anesthesiology
Osaka City University Graduate School of Medicine
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
Ethics Committee of Osaka City University Graduate School of Medicine
Address
1-5-7, Asahimachi, Abeno-ku, Osaka 545-8586 Japan
Tel
81-6-6646-6125
ethics@med.osaka-cu.ac.jp
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
| 2021 | Year | 06 | Month | 19 | 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
Preinitiation
Date of protocol fixation
| 2021 | Year | 04 | Month | 11 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 28 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 21 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Simultaneous measurements of non-invasive blood pressure and invasive blood pressure will be performed in closed chest conditions. Error Grid analysis will be conducted to compare the non-invasive blood pressure with the invasive blood pressure.
Management information
Registered date
| 2021 | Year | 06 | Month | 19 | Day |
Last modified on
| 2021 | Year | 06 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050935
