UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055984 |
|---|---|
| Receipt number | R000063953 |
| Scientific Title | Retrospective review of extubation methods and related complications in the operating room |
| Date of disclosure of the study information | 2024/11/01 |
| Last modified on | 2025/12/22 08:34:45 |
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Basic information
Public title
Retrospective review of extubation methods and related complications in the operating room
Acronym
Retrospective review of extubation methods and related complications in the operating room
Scientific Title
Retrospective review of extubation methods and related complications in the operating room
Scientific Title:Acronym
Retrospective review of extubation methods and related complications in the operating room
Region
| Japan |
Condition
Condition
Methods of awakening and extubation from general anesthesia and related respiratory adverse events
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study safer extubation methods by conducting a retrospective review of the extubation methods performed at our facility.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
SpO2 drop of more than 5% after extubation
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients undergoing general anesthesia with airway management and extubated in the operating room
2.Adult patients who are at least 18 years old at the time of general anesthesia
3.Patients who have obtained opt-out consent
Key exclusion criteria
1.Patients who left the operating room without extubation
2.Patients who express their refusal to participate in this study through a written withdrawal of consent
3.Other patients who are deemed unsuitable by the principal investigator.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Katsuhiko |
| Middle name | |
| Last name | Ishibashi |
Organization
Chiba University Hospital
Division name
Department of Anesthesiology
Zip code
2608677
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba
TEL
043-222-7171
katsu1484@chiba-u.jp
Public contact
Name of contact person
| 1st name | Katsuhiko |
| Middle name | |
| Last name | Ishibashi |
Organization
Chiba University Hospital
Division name
Department of Anesthesiology
Zip code
2608677
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba
TEL
043-222-7171
Homepage URL
katsu1484@chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
Chiba University Hospital Department of Anesthesiology
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
Chiba University Hospital Observational Research Ethics Review Committee
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba
Tel
043-222-7171
hsp-kansaturinri@chiba-u.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
HK202408-10
Org. issuing International ID_1
Chiba University Hospital Observational Research Ethics Review Committee
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 | 11 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
44
Results
Of the 22 patients in each group, analysis was performed on 14 patients who recalled missing data. In the SpO2-low group, the tidal volume per body weight (p=0.0216) was consciously lowered. No evidence of intentional differences in minute ventilation (p=0.212), respiratory rate (p=0.434), or exhaled CO2 concentration (p=0.597) were found between groups. As a secondary analysis, the ROC peak was created using the tidal volume per body weight, and the cutoff value was calculated to be 6.7ml/kg.
Results date posted
| 2025 | Year | 12 | Month | 22 | Day |
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
Completed
Date of protocol fixation
| 2024 | Year | 08 | Month | 19 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 02 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1.Study design
Retrospective case-control study
2.Study methods
Video recordings that are constantly recorded in the operating room will be referred to. To elucidate the risk factors for the occurrence of extubation-related respiratory complications, mainly the need for spontaneous breathing. This is a retrospective observational study. The relationship between patient background, anesthesia information, and biometric information prior to extubation and post-extubation respiratory complications will be investigated and analyzed.
Management information
Registered date
| 2024 | Year | 10 | Month | 29 | Day |
Last modified on
| 2025 | Year | 12 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063953
