UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018991 |
|---|---|
| Receipt number | R000021965 |
| Scientific Title | Clinical evaluation of new algorithm about non-invasive blood pressure monitoring during perioperative period. |
| Date of disclosure of the study information | 2015/09/14 |
| Last modified on | 2025/03/25 10:16:13 |
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Basic information
Public title
Clinical evaluation of new algorithm about non-invasive blood pressure monitoring during perioperative period.
Acronym
Improvement of non-invasive blood pressure monitoring.
Scientific Title
Clinical evaluation of new algorithm about non-invasive blood pressure monitoring during perioperative period.
Scientific Title:Acronym
Improvement of non-invasive blood pressure monitoring.
Region
| Japan |
Condition
Condition
Adult patients undergoing major surgery under general anesthesia
Classification by specialty
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery | Chest surgery |
| Obstetrics and Gynecology | Orthopedics | Urology |
| Anesthesiology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of precision and duration necessary to obtain data in newly developed non-invasive blood pressure monitor.
Basic objectives2
Others
Basic objectives -Others
Clinical appraisal of patient monitor
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Precision compared to invasive arterial pressure during general anesthesia
Key secondary outcomes
Difference of measurement time between new and conventional algorithm during general anesthesia
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who is indicated for invasive blood pressure monitoring
Patients undergoing curative surgery of malignancy.
Patients whose proposed surgery lasts more than 6 hours.
Patients whose predicted blood loss exceeds 1000ml
Key exclusion criteria
Not applicable
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yoshifumi |
| Middle name | |
| Last name | Kotake |
Organization
Toho University Ohashi Medical Center
Division name
Department of Anesthesiology
Zip code
053-8515
Address
2-17-6, Ohashi, Meguro, Tokyo, Japan
TEL
03-3468-1251
ykotake@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshifumi |
| Middle name | |
| Last name | Kotake |
Organization
Toho University Ohashi Medical Center
Division name
Department of Anesthesiology
Zip code
053-8515
Address
2-17-6, Ohashi, Meguro, Tokyo, Japan
TEL
03-3468-1251
Homepage URL
http://www.lab.toho-u.ac.jp/med/ohashi/anesth/
ykotake@med.toho-u.ac.jp
Sponsor or person
Institute
Department of Anesthesiology, Toho University Ohashi Medical Center
Institute
Department
Personal name
Funding Source
Organization
Toho University Ohashi Medical Center
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
None
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Institutional review board, toho university ohashi medical center
Address
2-22-36, Ohashi, meguro, Tokyo
Tel
03-3468-1251
secretary@oha.toho-u.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
東邦大学医療センター大橋病院(東京都）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 09 | Month | 14 | Day |
Related information
URL releasing protocol
https://www.lab.toho-u.ac.jp/med/ohashi/anesth/research/tjoimi000000107w.html
Publication of results
Published
Result
URL related to results and publications
https://www.lab.toho-u.ac.jp/med/ohashi/anesth/research/tjoimi000000107w.html
Number of participants that the trial has enrolled
60
Results
The success rate of iNIBP was 45% and 59% (p<0.01) with AF and SR, respectively. Measurement duration of iNIBP was not different between AF and SR group. The Lin concordance correlation coefficient of mean blood pressure of iNIBP against IAP of SR group and AF group was 0.83 and 0.77, respectively. The mean bias (SD) of mean blood pressure of iNIBP against IAP of SR group and AF group was 5.8 (8.9) mmHg and 7.1 (11.5) mmHg, respectively. The precision was significantly wider in AF group.
Results date posted
| 2025 | Year | 03 | Month | 25 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2025 | Year | 02 | Month | 19 | Day |
Baseline Characteristics
Patients undergoing non-cardiac surgery under general anesthesia with the indication of IAP monitoring enrolled in this study. Patients with pacemaker or cardioverter/defibrillator, patients in whom arterial catheter could not be placed on the contralateral side of the oscillometric blood pressure cuff, patients diagnosed and treated as peripheral artery diseases, were excluded from this study.
Participant flow
Anesthesia management was at the discretion of the attending anesthesiologists and NIBP was measured every 5 min during anesthetic management. After anesthetic induction, radial artery was cannulated with 22-gauge Teflon catheter (Introcan Safety, BBraun, Melsungen, Germany) and IAP was measured with either TruWave transducer or FloTrac sensor (Edwards Lifesciences, Irvine, CA, USA). During the preparation, air bubbles are meticulously removed from the circuit and the transducer was zero-referenced at the mid axillary line during the measurement. In this study, the IAP values were averaged in every 1 min and recorded.
Adverse events
none.
Outcome measures
The primary outcome of this study was the incidence when blood pressure was successfully determined during the inflationary phase. The secondary outcome was the duration of total measurement when inflationary measurement was unsuccessful and deflationary measurement was necessary.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2015 | Year | 08 | Month | 31 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 18 | Day |
Anticipated trial start date
| 2015 | Year | 09 | Month | 15 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2024 | Year | 12 | Month | 31 | Day |
Other
Other related information
The new algorithm has already been cleared of PMDA approval and has been on market. The new algorithm is characterized with shorter measurement time and lower inflation pressure. The purpose of this prospective, observational study is to confirm such advantages of new algorithm during perioperative period.
Management information
Registered date
| 2015 | Year | 09 | Month | 12 | Day |
Last modified on
| 2025 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021965
