UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036919 |
|---|---|
| Receipt number | R000042072 |
| Scientific Title | A study of usefulness of the cuff-leak test of the robotically-assisted surgery in head-down position. |
| Date of disclosure of the study information | 2019/06/02 |
| Last modified on | 2024/06/04 17:04:06 |
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Basic information
Public title
A study of usefulness of the cuff-leak test of the robotically-assisted surgery in head-down position.
Acronym
CLT study
Scientific Title
A study of usefulness of the cuff-leak test of the robotically-assisted surgery in head-down position.
Scientific Title:Acronym
CLT study
Region
| Japan |
Condition
Condition
Prostate cancer
Gynecologic diseases
Classification by specialty
| Obstetrics and Gynecology | Urology | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Usefulness of the cuff-leak test.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The wheezing after extubation.
Key secondary outcomes
The factor related to result of the cuff-leak test.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
The cuff-leak test before extubation
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients undergoing robotically-assisted surgery in head-down position.
Key exclusion criteria
Patients without consent.
Patients who did not extubate
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Koji |
| Middle name | |
| Last name | Saito |
Organization
Tohoku University Hospital
Division name
Intensive care unit
Zip code
980-8574
Address
Seiryo-cho 1-1,Sendai-shi,Miyagi.
TEL
022-717-7321
k-saito@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Koji |
| Middle name | |
| Last name | Saito |
Organization
Tohoku University Hospital
Division name
Intensive care unit
Zip code
980-8574
Address
Seiryo-cho 1-1,Sendai-shi,Miyagi.
TEL
022-717-7321
Homepage URL
k-saito@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Hospital
Institute
Department
Personal name
Funding Source
Organization
Tohoku University Hospital
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
Tohoku University Hospital
Address
Seiryo-cho 1-1,Sendai-shi,Miyagi.
Tel
022-717-7321
k-saito@tohoku.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 | 06 | Month | 02 | 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
Completed
Date of protocol fixation
| 2019 | Year | 05 | Month | 21 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 03 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 03 | Day |
Last follow-up date
| 2021 | Year | 06 | Month | 03 | 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 | 06 | Month | 01 | Day |
Last modified on
| 2024 | Year | 06 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042072
