UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058870 |
|---|---|
| Receipt number | R000066658 |
| Scientific Title | Association Between Cumulative Triple Low Duration (Intraoperative Hypotension, Low BIS Values, and Low Inhaled Anesthetic Concentrations) and Postoperative Outcomes and Preoperative Frailty in Patients Undergoing Transcatheter Aortic Valve Replacement: A Retrospective Observational Study |
| Date of disclosure of the study information | 2025/08/25 |
| Last modified on | 2025/08/22 18:00:57 |
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Basic information
Public title
Association Between Cumulative Triple Low Duration (Intraoperative Hypotension, Low BIS Values, and Low Inhaled Anesthetic Concentrations) and Postoperative Outcomes and Preoperative Frailty in Patients Undergoing Transcatheter Aortic Valve Replacement: A Retrospective Observational Study
Acronym
Association between cumulative time of triple low (intraoperative hypotension, low BIS value, low inhaled anesthetic concentration) and postoperative outcomes, and preoperative frailty
Scientific Title
Association Between Cumulative Triple Low Duration (Intraoperative Hypotension, Low BIS Values, and Low Inhaled Anesthetic Concentrations) and Postoperative Outcomes and Preoperative Frailty in Patients Undergoing Transcatheter Aortic Valve Replacement: A Retrospective Observational Study
Scientific Title:Acronym
Association between cumulative time of triple low (intraoperative hypotension, low BIS value, low inhaled anesthetic concentration) and postoperative outcomes, and preoperative frailty
Region
| Japan |
Condition
Condition
Severe aortic valve stenosis
Classification by specialty
| Cardiology | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study investigates whether the cumulative duration of triple low (intraoperative hypotension, low BIS, and low anesthetic concentration) during anesthesia is associated with preoperative frailty and postoperative outcomes, such as delirium, complications, hospital stay, and 30-day mortality in elderly patients undergoing TAVI for severe aortic stenosis.
Basic objectives2
Others
Basic objectives -Others
relevance
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
CK-MB value the day after surgery
Key secondary outcomes
Duke Activity Status Index, Preoperative frailty index, Preoperative NT-proBNP value, Postoperative CK/CK-MB, Postoperative troponin value, Number of days in CCU, Number of days in hospital, 30-day mortality after surgery, Postoperative complications (Clavien-Dindo)
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
| 16 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who underwent planned transcatheter aortic valve implantation for severe aortic stenosis at our hospital between December 2023 and April 2025
Key exclusion criteria
1. Patients with missing BIS measurements during anesthesia for 15 minutes or more
2. Patients undergoing concurrent surgery
3. Patients with coexisting neuromuscular diseases
Target sample size
376
Research contact person
Name of lead principal investigator
| 1st name | Hideki |
| Middle name | |
| Last name | Hino |
Organization
Osaka Metropolitan University
Division name
Department of Anesthesiology
Zip code
545-8586
Address
1-5-7 Asahimachi, Abeno-ku, Osaka
TEL
0666452186
HinoH@omu.ac.jp
Public contact
Name of contact person
| 1st name | Hideki |
| Middle name | |
| Last name | Hino |
Organization
Osaka Metropolitan University
Division name
Department of Anesthesiology
Zip code
545-8586
Address
1-5-7 Asahimachi, Abeno-ku, Osaka
TEL
0666452186
Homepage URL
m1165192@yahoo.co.jp
Sponsor or person
Institute
Osaka Metropolitan University
Institute
Department
Personal name
Funding Source
Organization
Osaka Metropolitan University
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
Ethical Committee of Osaka Metropolitan University Graduate School of Medicine
Address
1-2-7 Asahimachi, Abeno-ku, Osaka
Tel
0666453456
gr-a-knky-ethics@omu.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
| 2025 | Year | 08 | Month | 25 | 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 | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 08 | Month | 22 | Day |
Last follow-up date
| 2029 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Inclusion Criteria:
Patients who underwent elective transcatheter aortic valve implantation (TAVI) for severe aortic stenosis at our institution between May 2021 and June 2025.
Exclusion Criteria:
1. Patients with missing BIS measurements for more than 15 minutes during anesthesia
2. Patients undergoing concomitant surgery with TAVI
3. Patients with comorbid neuromuscular disorders
Management information
Registered date
| 2025 | Year | 08 | Month | 22 | Day |
Last modified on
| 2025 | Year | 08 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066658
