UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013400 |
|---|---|
| Receipt number | R000015631 |
| Scientific Title | The randomized control trial about the stability of double-lumen tube |
| Date of disclosure of the study information | 2014/03/11 |
| Last modified on | 2017/04/30 21:13:39 |
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Basic information
Public title
The randomized control trial about the stability of double-lumen tube
Acronym
The randomized control trial about the stability of double-lumen tube
Scientific Title
The randomized control trial about the stability of double-lumen tube
Scientific Title:Acronym
The randomized control trial about the stability of double-lumen tube
Region
| Japan |
Condition
Condition
Lung cancer, pneumothorax, mediastinal tumor
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare the stability of the double-lumen tubes (newly developed and existing products)
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Malposition of bronchus lumen
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is 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
Double-lumen tube (new product group)
Interventions/Control_2
Double-lumen tube (existing product group)
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
patient who was scheduled elective thoracic surgery with DLT
Key exclusion criteria
1) history of tracheal or laryngeal operation
2) pregnancy
3) under 20 years old
4) patient who was assessed inapopropriate
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshimi Inagaki |
Organization
Tottori University, Faculty of Medicine
Division name
Division of Anesthesiology and Critical Care Medicine
Zip code
Address
36-1 Nishi-cho, Yonago, 683-8504, Japan
TEL
0859-38-6657
yinagaki@grape.med.tottori-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshinori Kitagawa |
Organization
Tottori University Hospital
Division name
Department of Anesthesiology
Zip code
Address
36-1 Nishi-cho, Yonago, 683-8504, Japan
TEL
0859-38-6657
Homepage URL
kitagawa@med.tottori-u.ac.jp
Sponsor or person
Institute
Tottori University, Faculty of Medicine, Division of Anesthesiology and Critical Care Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 03 | Month | 11 | 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
| 2014 | Year | 02 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 03 | Month | 12 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 03 | Month | 11 | Day |
Last modified on
| 2017 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015631
