UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025600 |
|---|---|
| Receipt number | R000028326 |
| Scientific Title | Evaluation of prediction score of postoperative hoarseness after general anesthesia |
| Date of disclosure of the study information | 2017/01/10 |
| Last modified on | 2018/03/05 13:25:06 |
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Basic information
Public title
Evaluation of prediction score of postoperative hoarseness after general anesthesia
Acronym
Prediction score of postoperatice hoarseness after general anesthesia
Scientific Title
Evaluation of prediction score of postoperative hoarseness after general anesthesia
Scientific Title:Acronym
Prediction score of postoperatice hoarseness after general anesthesia
Region
| Japan |
Condition
Condition
Patient who undergo general anesthesia with tracheal intubation
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1To validate the sex, laryngeal deviation, intubation resistance for postoperative hoarseness.
2To validate the Cormack grade, intubation resistance, aneesthesia time for postoperative sore throat
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To validate the sex, laryngeal deviation, intubation resistance for postoperative hoarseness.
Key secondary outcomes
To validate the Cormack grade, intubation resistance, aneesthesia time for postoperative sore throat
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who underwent general anesthesia under tracheal intubation
Key exclusion criteria
Patients with apparent difficult airway
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiaki Minami |
Organization
Osaka Medical College
Division name
Dept of Anestheisology
Zip code
Address
2-7 Daigaku-machi, Takatsuk city
TEL
0726-84-6361
ane022@osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nobuyasu Komasawa |
Organization
Osaka Medical College
Division name
Department of Anesthesiology
Zip code
Address
2-7Daigaku-machi, Takatsuki city
TEL
0726-84-6361
Homepage URL
ane078@osaka-med.ac.jp
Sponsor or person
Institute
Osaka Medical College
Institute
Department
Personal name
Funding Source
Organization
Osaka Medical College
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
Address
Tel
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
大阪医科大学附属病院、松下記念病院、第一東和会病院、北摂総合病院
国立循環器病研究センターは統計解析を担当する
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 01 | 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
Resistance and anesthetic time was an independent risk factor for postoperative hoarseness.
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
| 2017 | Year | 01 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 01 | Month | 13 | Day |
Last follow-up date
| 2017 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2017 | Year | 07 | Month | 03 | Day |
Date trial data considered complete
| 2017 | Year | 07 | Month | 10 | Day |
Date analysis concluded
| 2017 | Year | 07 | Month | 18 | Day |
Other
Other related information
To validate the sex, laryngeal deviation, intubation resistance for postoperative hoarseness.
To validate the Cormack grade, intubation resistance, aneesthesia time for postoperative sore throat
Management information
Registered date
| 2017 | Year | 01 | Month | 10 | Day |
Last modified on
| 2018 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028326
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
