UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061549 |
|---|---|
| Receipt number | R000070429 |
| Scientific Title | Effect of Lung-Protective Ventilation During General Anesthesia on the Reduction of Complication Incidence and Airway Patency: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2026/05/13 |
| Last modified on | 2026/05/13 11:29:01 |
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Basic information
Public title
Effect of Lung-Protective Ventilation During General Anesthesia on the Reduction of Complication Incidence and Airway Patency: A Randomized Controlled Trial
Acronym
Effect of Lung-Protective Ventilation During General Anesthesia on the Reduction of Complication Incidence and Airway Patency: A Randomized Controlled Trial
Scientific Title
Effect of Lung-Protective Ventilation During General Anesthesia on the Reduction of Complication Incidence and Airway Patency: A Randomized Controlled Trial
Scientific Title:Acronym
Effect of Lung-Protective Ventilation During General Anesthesia on the Reduction of Complication Incidence and Airway Patency: A Randomized Controlled Trial
Region
| Japan |
Condition
Condition
Minor surgical conditions, primarily including superficial bladder cancer
Classification by specialty
| Anesthesiology | Operative medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To demonstrate that the use of lung-protective ventilation during general anesthesia reduces upper airway-related complications.
To evaluate the effects of lung-protective ventilation on the upper airway, particularly on glottic patency.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of capnography-detected abnormalities in end-tidal carbon dioxide waveforms immediately after neuromuscular blockade reversal under supraglottic airway device management
Key secondary outcomes
Glottic angle observed fiberoptically through a supraglottic airway device
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Lung-protective ventilation group (5 mL/kg)
Interventions/Control_2
Conventional ventilation group (8 mL/kg)
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)Adults aged >=18 years at the time of consent.
2)Adult patients scheduled to undergo minor surgical procedures under general anesthesia managed with a supraglottic airway device.
3)Patients who have received a full explanation of the study, have adequately understood it, and have provided written informed consent voluntarily.
Key exclusion criteria
Patients meeting any of the following criteria:
1)Patients whose upper airway is managed with devices other than a supraglottic airway device.
2)Patients who have withdrawn consent and expressed refusal to participate in this study.
3)Patients with severe hepatic dysfunction.
4)Patients in whom succinylcholine is contraindicated.
5)Patients deemed unsuitable for the study by the principal investigator.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Katsuhiko |
| Middle name | |
| Last name | Ishibashi |
Organization
Institute of Science Tokyo Hospital
Division name
Anesthesiology
Zip code
113-8510
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL
03-3813-6111
ishibashi.k.3dd4@m.isct.ac.jp
Public contact
Name of contact person
| 1st name | Katsuhiko |
| Middle name | |
| Last name | Ishibashi |
Organization
Institute of Science Tokyo Hospital
Division name
Anesthesiology
Zip code
113-8510
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL
03-3813-6111
Homepage URL
ishibashi.k.3dd4@m.isct.ac.jp
Sponsor or person
Institute
Institute of Science Tokyo
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology (MEXT)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Research Ethics Committee of Institute of Science Tokyo
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
Tel
03-5803-4547
rinri.adm@tmd.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
jRCT1030250783
Org. issuing International ID_1
Japan Registry of Clinical Trials
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
東京科学大学病院(東京都）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 05 | Month | 13 | 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
Open public recruiting
Date of protocol fixation
| 2026 | Year | 03 | Month | 06 | Day |
Date of IRB
| 2026 | Year | 02 | Month | 24 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 05 | Month | 13 | Day |
Last modified on
| 2026 | Year | 05 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070429
