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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033840
Receipt No. R000037787
Scientific Title Examine wheather the bronchial curvature under spontaneous breathing occurs under general anesthesia
Date of disclosure of the study information 2018/08/21
Last modified on 2018/08/21

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Basic information
Public title Examine wheather the bronchial curvature under spontaneous breathing occurs under general anesthesia
Acronym Examination of bronchial deviation with position change
Scientific Title Examine wheather the bronchial curvature under spontaneous breathing occurs under general anesthesia
Scientific Title:Acronym Examination of bronchial deviation with position change
Region
Japan

Condition
Condition patients receiving thoracic surgery
Classification by specialty
Anesthesiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To measure deviation of the bronchus by postural change from supine to surgical lateral position in patients under general anesthesia for thoracic surgery
Basic objectives2 Others
Basic objectives -Others To measure deviation of the diaphragm with position change
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Deviation of bronchus and diaphragm
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 Chest radiography under spontaneous respiration
Interventions/Control_2 Chest radiography under general anesthesia
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
75 years-old >=
Gender Male and Female
Key inclusion criteria Patients scheduled to undergo thoracic surgery in lateral position
ASA physical status 1 or 2
Patients with prior written consent
Key exclusion criteria Patient with past history of lobectomy
Presence of pleural effusion, a very distorted anatomy of the tracheobronchial tree and severe pleural adhesions such as tuberculosis
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yusuke Ubukata
Organization Ebara Hospital
Division name Department of Anesthesiolosy
Zip code
Address 4-5-10 Higashiyukigaya, Ota-ku, Tokyo, Japan
TEL 03-5734-8000
Email yuusuke-ubukata1@tokyo-hmt.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yusuke Ubukata
Organization Ebara Hospital
Division name Department of Anesthesiolosy
Zip code
Address 4-5-10 Higashiyukigaya, Ota-ku, Tokyo, Japan
TEL 03-5734-8000
Homepage URL
Email yuusuke-ubukata1@tokyo-hmt.jp

Sponsor
Institute Department of Anesthesiolosy, Ebara Hospital
Institute
Department

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
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

Other administrative information
Date of disclosure of the study information
2018 Year 08 Month 21 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 Enrolling by invitation
Date of protocol fixation
2018 Year 06 Month 10 Day
Date of IRB
Anticipated trial start date
2018 Year 08 Month 21 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
2018 Year 08 Month 21 Day
Last modified on
2018 Year 08 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037787

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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