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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000036388
Receipt No. R000041458
Scientific Title the inhibitory effect of postoperative sore throat by continuous measurement of cuff pressure
Date of disclosure of the study information 2019/04/03
Last modified on 2020/04/05

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Basic information
Public title the inhibitory effect of postoperative sore throat by continuous measurement of cuff pressure
Acronym the inhibitory effect of postoperative sore throat by continuous measurement of cuff pressure
Scientific Title the inhibitory effect of postoperative sore throat by continuous measurement of cuff pressure
Scientific Title:Acronym the inhibitory effect of postoperative sore throat by continuous measurement of cuff pressure
Region
Japan

Condition
Condition the patients scheduled to laparoscopic surgery
Classification by specialty
Anesthesiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We evaluate the contribution of postoperative sore throat and horseness by maintaining cuff pressure
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes We evaluate the degree of postoperative sore throat and horseness using visual analog scale (VAS) at 1 postoperative day.
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 Treatment
Type of intervention
Device,equipment
Interventions/Control_1 our study will be continuing for 3 days.
The low cuff pressure group (20 cmH2O)
Interventions/Control_2 our study will be continuing for 3 days.
The high cuff pressure group (30 cmH2O)
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 The patients scheduled to laparoscopic surgery
Key exclusion criteria The patients who are difficult of mutual understanding
or who don't have an agreement for our study
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Mitsutaka
Middle name
Last name Edanaga
Organization Sapporo Medical University Schoo of Medicine
Division name Department of Anesthesiology
Zip code 060-8543
Address S1, W16, Chuo-ku, Sapporo, Hokkaido, Japan
TEL 011-611-2111
Email edanaka@sapmed.ac.jp

Public contact
Name of contact person
1st name Kouji
Middle name
Last name Hamaya
Organization Sapporo Medical University Schoo of Medicine
Division name hospital section
Zip code 060-8543
Address S1, W16, Chuo-ku, Sapporo, Hokkaido, Japan
TEL 011-611-2111
Homepage URL
Email ko-hamaya-923@sapmed.ac.jp

Sponsor
Institute Sapporo Medical University Schoo of Medicine
Institute
Department

Funding Source
Organization Sapporo Medical University Schoo of Medicine
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 Hospital section
Address S1, W16, Chuo-ku, Sapporo, Hokkaido, Japan
Tel 011-611-2111
Email ko-hamaya-923@sapmed.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
2019 Year 04 Month 03 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 No longer recruiting
Date of protocol fixation
2019 Year 03 Month 14 Day
Date of IRB
2019 Year 03 Month 14 Day
Anticipated trial start date
2019 Year 04 Month 08 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 04 Month 02 Day
Last modified on
2020 Year 04 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041458

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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