UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059715 |
|---|---|
| Receipt number | R000068290 |
| Scientific Title | Postoperative hoarseness after endotracheal intubation in aged surgical patients: its incidnet and identification of its risk factors |
| Date of disclosure of the study information | 2025/11/10 |
| Last modified on | 2025/11/10 11:13:49 |
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Basic information
Public title
Postoperative hoarseness after endotracheal intubation in aged surgical patients: its incidnet and identification of its risk factors
Acronym
Postoperative hoarseness after endotracheal intubation in aged patients
Scientific Title
Postoperative hoarseness after endotracheal intubation in aged surgical patients: its incidnet and identification of its risk factors
Scientific Title:Acronym
Postoperative hoarseness after endotracheal intubation in aged patients
Region
| Japan |
Condition
Condition
Aged patients undergoing genneral anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To idetify the incidence of postoperaive hoarseness after endotracheal intubation and risk factors to facilitate this complication
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidece of postoperative hoaseness and duration of horaseness.
Risk facotrs to prolong postoperative horaseness: sex, age, the duration of intubation, operator to perform endotracheal intubation.
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Aged (65 and more than 65 years old) patients
Key exclusion criteria
None
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Yukio |
| Middle name | |
| Last name | Hayashi |
Organization
Anesthesiology, Yoka Municipal Hospital
Division name
Anestheisology
Zip code
079-662-5555
Address
1878-1, Yoka, Yoka-cho, Yabu, Hyogo, 667-0021, Japan
TEL
09039933175
yhayashi@anes.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Yukio |
| Middle name | |
| Last name | Hayashi |
Organization
Yoka Municipal Hospital
Division name
Anesthesiology
Zip code
667-0021
Address
1878-1, Yoka, Yoka-cho, Yabu, Hyogo, 667-0021, Japan
TEL
09039933175
Homepage URL
yhayashi@anes.med.osaka-u.ac.jp
Sponsor or person
Institute
Yoka Municipal Hospital
Institute
Department
Personal name
Yukio Hayashi
Funding Source
Organization
none
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
IRB of Yoka Municipal Hospital
Address
1878-1, Yoka, Yoka-cho, Yabu, Hyogo, 667-0021, Japan
Tel
0796625555
somu1@hosp.yoka.hyogo.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
| 2025 | Year | 11 | Month | 10 | 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
| 2025 | Year | 05 | Month | 08 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 14 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 15 | Day |
Last follow-up date
| 2026 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 06 | Month | 10 | Day |
Date trial data considered complete
| 2026 | Year | 06 | Month | 15 | Day |
Date analysis concluded
| 2026 | Year | 12 | Month | 30 | Day |
Other
Other related information
None
Management information
Registered date
| 2025 | Year | 11 | Month | 10 | Day |
Last modified on
| 2025 | Year | 11 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068290
