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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021890
Receipt No. 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

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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
Last 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
Email whoami@hp.pref.hyogo.jp

Public contact
1st 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
Email whoami@hp.pref.hyogo.jp

Sponsor
Institute Department of Anesthesia
Hyogo Cancer Center
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025240

Research Plan
Registered date File name
2017/10/13 NECK_DLT研究実施計画書_2.pages

Research case data specifications
Registered date File name

Research case data
Registered date File name
2017/10/13 左用挿管 broncho ver処理用.xlsx


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