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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025600
Receipt No. 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

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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
Email 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
Email ane078@osaka-med.ac.jp

Sponsor
Institute Osaka Medical College
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028326

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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