UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061022 |
|---|---|
| Receipt number | R000069831 |
| Scientific Title | Effects of Endotracheal Tube Warming and Spiral Deflation on the Force Required for Intubation and Postoperative Sore Throat |
| Date of disclosure of the study information | 2026/03/23 |
| Last modified on | 2026/03/23 16:34:44 |
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Basic information
Public title
Effects of Endotracheal Tube Warming and Spiral Deflation on the Force Required for Intubation and Postoperative Sore Throat
Acronym
Effects of Endotracheal Tube Warming and Spiral Deflation on the Force Required for Intubation and Postoperative Sore Throat
Scientific Title
Effects of Endotracheal Tube Warming and Spiral Deflation on the Force Required for Intubation and Postoperative Sore Throat
Scientific Title:Acronym
Effects of Endotracheal Tube Warming and Spiral Deflation on the Force Required for Intubation and Postoperative Sore Throat
Region
| Japan |
Condition
Condition
patients undergoing general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The primary objective of this study is to evaluate, in patients undergoing tracheal intubation with a single-lumen tube under general anesthesia, whether pre-intubation warming and spiral deflation of the endotracheal tube reduce the force required for intubation compared with the conventional method.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the maximum force required for intubation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
In the intervention group, the endotracheal tube will be warmed and then used after spiral deflation of the cuff.
Interventions/Control_2
In the control group, an endotracheal tube prepared with conventional cuff deflation will be used.
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
patients aged 20 years or older with American Society of Anesthesiologists Physical Status class I or II
Key exclusion criteria
patients with American Society of Anesthesiologists Physical Status class III, IV, or V; patients undergoing head and neck surgery; patients with preoperative sore throat or hoarseness; patients with a history of smoking; patients from whom informed consent cannot be obtained; pregnant women; patients with limited mouth opening; patients with anticipated difficult intubation; and patients with cervical spine disease
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | HIROKI |
| Middle name | |
| Last name | YONEZAWA |
Organization
Tokushima University Hospital
Division name
Department of Anesthesiology
Zip code
7708503
Address
2-50-1 Kuramoto-cho, Tokushima
TEL
0886313111
yonezawa.hiroki.2@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | HIROKI |
| Middle name | |
| Last name | YONEZAWA |
Organization
Tokushima University Hospital
Division name
Department of Anesthesiology
Zip code
7708503
Address
2-50-1 Kuramoto-cho, Tokushima
TEL
0886313111
Homepage URL
yonezawa.hiroki.2@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University Hospital
Institute
Department
Personal name
Funding Source
Organization
No external funding will be used for this study.
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
Tokushima University Hospital Ethics Committee
Address
2-50-1 Kuramoto-cho, Tokushima
Tel
0886313111
first-ec@tokushima-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 | 03 | Month | 23 | 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
| 2026 | Year | 03 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 05 | Month | 20 | Day |
Last follow-up date
| 2028 | Year | 06 | Month | 01 | 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 | 03 | Month | 23 | Day |
Last modified on
| 2026 | Year | 03 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069831
