UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046046 |
|---|---|
| Receipt number | R000052551 |
| Scientific Title | Sore throat and discomfort following endotracheal intubation. |
| Date of disclosure of the study information | 2021/11/15 |
| Last modified on | 2023/05/15 20:07:18 |
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Basic information
Public title
Sore throat and discomfort following endotracheal intubation.
Acronym
Sore throat and discomfort following endotracheal intubation.
Scientific Title
Sore throat and discomfort following endotracheal intubation.
Scientific Title:Acronym
Sore throat and discomfort following endotracheal intubation. Prospective observational study
Region
| Japan |
Condition
Condition
Sore throat
Classification by specialty
| Surgery in general | Vascular surgery | Breast surgery |
| Ophthalmology | Dermatology | Oto-rhino-laryngology |
| Orthopedics | Urology | Anesthesiology |
| Plastic surgery | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Assess of relation between smoking and sore throat following endotracheal intubation
Basic objectives2
Others
Basic objectives -Others
Assess of risk factor of sore throat, hoarseness and discomfort following endotracheal intubation
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence of sore throat following endotracheal intubation (24 hours after extubation)
Key secondary outcomes
Severity of sore throat and discomfort following endotracheal intubation (2, 24 hours after extubation)
Incidence of hoarseness following endotracheal intubation (24 hours after extubation)
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Scheduled surgery
Oral endotracheal intubation
Ability to read and understand Japanese
Key exclusion criteria
Emergence surgery
Rapid sequence induction
Use of succinylcholine
Surgery in the mouth or the throat area
Thyroidectomy
Patients who present throat symptoms
Target sample size
1635
Research contact person
Name of lead principal investigator
| 1st name | Tomonori |
| Middle name | |
| Last name | Furuya |
Organization
Nihon University School of Medicine
Division name
Department of Anesthesiology
Zip code
1738610
Address
30-1 Oyaguchi-Kamicho, Itabashi-ku, Tokyo 173-8610, Japan.
TEL
03-3972-8111
furuya.tomonori@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomonori |
| Middle name | |
| Last name | Furuya |
Organization
Nihon University School of Medicine
Division name
Department of Anesthesiology
Zip code
173-8610
Address
30-1 Oyaguchi-Kamicho, Itabashi-ku, Tokyo 173-8610, Japan.
TEL
03-3972-8111
Homepage URL
furuya.tomonori@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Nihon University School of Medicine, Itabashi hospital
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
Nihon University School of Medicine, Itabashi hospital
Address
30-1 Oyaguchi-Kamicho, Itabashi-ku, Tokyo 173-8610, Japan.
Tel
0339728111
furuya.tomonori@nihon-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
日本大学医学部板橋病院
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 11 | Month | 15 | 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
Completed
Date of protocol fixation
| 2021 | Year | 11 | Month | 15 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 04 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 15 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2022 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 10 | Month | 31 | Day |
Other
Other related information
No significant problem
Management information
Registered date
| 2021 | Year | 11 | Month | 11 | Day |
Last modified on
| 2023 | Year | 05 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052551
