UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060429 |
|---|---|
| Receipt number | R000069131 |
| Scientific Title | Association between methods of endotracheal tube cuff pressure measurement and postoperative anesthesia-related complications in dental surgery under general anesthesia: a retrospective observational study |
| Date of disclosure of the study information | 2026/02/01 |
| Last modified on | 2026/01/21 20:04:15 |
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Basic information
Public title
Association between endotracheal tube cuff pressure management and postoperative sore throat and hoarseness in dental surgery under general anesthesia
Acronym
Dental GA Cuff Pressure Study
Scientific Title
Association between methods of endotracheal tube cuff pressure measurement and postoperative anesthesia-related complications in dental surgery under general anesthesia: a retrospective observational study
Scientific Title:Acronym
Retrospective Dental GA Cuff Pressure Study
Region
| Japan |
Condition
Condition
Postoperative airway-related complications following general anesthesia
Classification by specialty
| Anesthesiology | Oral surgery | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to investigate the association between methods of endotracheal tube cuff pressure management (automatic versus manual) and the severity of postoperative sore throat and hoarseness in patients undergoing dental surgery under general anesthesia.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Severity of postoperative sore throat and hoarseness. (Assessed using a 100-mm Visual Analog Scale [VAS] at 2 hours and 1 day after 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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients meeting all of the following criteria will be included:
1. Adult patients (aged 18 years or older) who underwent dental surgery under general anesthesia at our institution
2. Patients who received tracheal intubation during general anesthesia
3. Cases in which the method of endotracheal tube cuff pressure management (automatic or manual) was documented in the medical records
4. Cases with documented postoperative assessments of sore throat and/or hoarseness at 2 hours and/or 1 day after surgery
Key exclusion criteria
Patients meeting any of the following criteria will be excluded:
1. Patients who required continued tracheal intubation after surgery
2. Patients with pre-existing sore throat or hoarseness before surgery
3. Patients with a tracheostomy
4. Cases with insufficient clinical data required for outcome assessment
Target sample size
72
Research contact person
Name of lead principal investigator
| 1st name | Shota |
| Middle name | |
| Last name | Tsukimoto |
Organization
Nagasaki University Hospital
Division name
Department of Dental Anesthesiology
Zip code
852-8501
Address
1-7-1, Sakamoto, Nagasaki, Nagasaki, Japan
TEL
095-819-7714
shtsukimoto@gmail.com
Public contact
Name of contact person
| 1st name | Shota |
| Middle name | |
| Last name | Tsukimoto |
Organization
Nagasaki University Hospital
Division name
Department of dental anesthesiology
Zip code
852-8501
Address
1-7-1 Sakamoto, Nagasaki-shi, Nagasaki-ken
TEL
095-821-7714
Homepage URL
s-tsukimoto@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki university hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagasaki University Hospital Clinical Research Ethics Committee
Address
1-7-1 Sakamoto, Nagasaki-shi, Nagasaki-ken
Tel
095-819-7229
gaibushikin@ml.nagasaki-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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 02 | Month | 01 | 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
37
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
No longer recruiting
Date of protocol fixation
| 2025 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2026 | Year | 01 | Month | 21 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a retrospective observational study, and no intervention was assigned for research purposes.
Management information
Registered date
| 2026 | Year | 01 | Month | 21 | Day |
Last modified on
| 2026 | Year | 01 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069131
