UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021890 |
|---|---|
| Receipt number | R000025240 |
| Scientific Title | Effects of neck rotation on left-sided double lumen tube positioning |
| Date of disclosure of the study information | 2016/04/12 |
| Last modified on | 2017/03/30 14:50:29 |
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Basic information
Public title
Effects of neck rotation on left-sided double lumen tube positioning
Acronym
Effects of neck rotation on left-sided double lumen tube positioning
Scientific Title
Effects of neck rotation on left-sided double lumen tube positioning
Scientific Title:Acronym
Effects of neck rotation on left-sided double lumen tube positioning
Region
| Japan |
Condition
Condition
Differential lung ventilation
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Compare the neck rotation and fiberoptic bronchoscopy guide as a correction method of left-sided double lumen tube malposition.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Success ratio of left bronchial intubation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
| Maneuver |
Interventions/Control_1
Right rotation of the neck
Interventions/Control_2
Fiberoptic bronchoscopy guided insertion
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Cases resulted in right sided malposition of left double lumen tube.
Key exclusion criteria
none
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiromi Katoh |
Organization
Hyogo Cancer Center
Division name
Department of Anesthesia
Zip code
Address
13-70 Kitaoji Akashi
TEL
0789291151
whoami@hp.pref.hyogo.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiromi Katoh |
Organization
Hyogo Cancer Center
Division name
Department of Anesthesia
Zip code
Address
13-70 Kitaoji Akashi
TEL
0789291151
Homepage URL
whoami@hp.pref.hyogo.jp
Sponsor or person
Institute
Department of Anesthesia
Hyogo Cancer Center
Institute
Department
Personal name
Funding Source
Organization
Department of Anesthesia
Hyogo Cancer Center
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Japan
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
兵庫県立がんセンター
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 04 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://confit.atlas.jp/guide/event/jsa64/static/64th_program
Number of participants that the trial has enrolled
Results
Twenty six cases resulted 26cases of misplacement into the left double lumen tube into the right bronchus. Optical bronchofiber scope guide corrected 24 of 26cases into the left bronchus. The right sided neck rotation also revealed 24 correct placement of bronchial tube into the left bronchus. The two failed cases were correctly placed by another method respectively.
The neck rotation was effective for correct positioning of left double lumen tube as bronchofiber guide, and these two method are suspected as complementary.
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
| 2016 | Year | 03 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | Month | 13 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 30 | Day |
Date trial data considered complete
| 2017 | Year | 03 | Month | 30 | Day |
Date analysis concluded
| 2017 | Year | 03 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 04 | Month | 12 | Day |
Last modified on
| 2017 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025240
