UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation of the deviation of trachea, bronchi, and diaphragm with position change
Title of the study (Brief title)	Investigation of the deviation of trachea, bronchi, and diaphragm with position change
Region	Japan

Condition
Condition	healthy adult volunteers
Classification by specialty	Anesthesiology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the deviation of trachea, bronchi, and diaphragm after turning from supine to lateral position in healthy volunteers.
Basic objectives2	Others
Basic objectives -Others	To examine the deviation of trachea, bronchi, and diaphragm.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Deviation of trachea, bronchi, 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 in supine position
Interventions/Control_2	Chest radiography in lateral position
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	70 years-old >=
Gender	Male and Female
Key inclusion criteria	Healthy male or female volunteers with prior written consent, aged from 20 to70
Key exclusion criteria	1.Known or possible pregnancy 2.Subjects who do not provide written informed consent
Target sample size	20

Research contact person
Name of lead principal investigator	Yusuke Ubukata
Organization	Ebara Hospital
Division name	Department of Anesthesiology
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	Yusuke Ubukata
Organization	Ebara Hospital
Division name	Department of Anesthesiology
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 Anesthesiology, 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)

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	2017 Year 05 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 04 Month 14 Day
Anticipated trial start date	2017 Year 05 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 04 Month 18 Day
Last modified on	2017 Year 09 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030995