UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036388 |
|---|---|
| Receipt number | 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 | 2022/04/05 14:43:45 |
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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
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
ko-hamaya-923@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University Schoo of Medicine
Institute
Department
Personal name
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
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
100
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
| 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
| 2022 | Year | 04 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041458
| 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 |
