UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012076 |
|---|---|
| Receipt number | R000014116 |
| Scientific Title | Safety comparison in the double-lumen tube intubation. |
| Date of disclosure of the study information | 2014/04/01 |
| Last modified on | 2020/04/02 13:10:44 |
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Basic information
Public title
Safety comparison in the double-lumen tube intubation.
Acronym
Safety comparison in the double-lumen tube intubation.
Scientific Title
Safety comparison in the double-lumen tube intubation.
Scientific Title:Acronym
Safety comparison in the double-lumen tube intubation.
Region
| Japan |
Condition
Condition
Patients who required thoracic surgery in general anesthesia.
Classification by specialty
| Surgery in general | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Safety comparison of the double-lumen tube intubation procedures.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Occurrence frequency of the complication
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Intubation with a bronchus fiberscope in left lumen.
Interventions/Control_2
Intubation with a bronchus fiberscope in right lumen.
Interventions/Control_3
Intubation without a bronchus fiberscope.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who required a double-lumen tube intubation.
Key exclusion criteria
Patients with difficult airway, with full stomach, and with anomal airway.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Tanaka |
Organization
Asahikawa Medical University
Division name
Anesthesiology and Critical Care Medicine
Zip code
Address
2-1-1-1 Midorigaoka Higashi, Asahikawa, Japan
TEL
0166-68-2583
rxe06152@nifty.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Tanaka |
Organization
Asahikawa Medical Universit
Division name
Anesthesiology and Critical Care Medicine
Zip code
Address
2-1-1-1 Midorigaoka Higashi, Asahikawa, Japan
TEL
0166-68-2583
Homepage URL
rxe06152@nifty.ne.jp
Sponsor or person
Institute
Asahikawa Medical University
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 | 04 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2013 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2013 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2013 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 10 | Month | 19 | Day |
Last modified on
| 2020 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014116
| 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 |
