UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027040
Receipt number R000030995
Scientific Title Investigation of the deviation of trachea, bronchi, and diaphragm with position change
Date of disclosure of the study information 2017/05/01
Last modified on 2017/09/05 15:24:58

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Basic information

Public title

Investigation of the deviation of trachea, bronchi, and diaphragm with position change

Acronym

Investigation of the deviation of trachea, bronchi, and diaphragm with position change

Scientific Title

Investigation of the deviation of trachea, bronchi, and diaphragm with position change

Scientific Title:Acronym

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

1st name
Middle name
Last name Yusuke Ubukata

Organization

Ebara Hospital

Division name

Department of Anesthesiology

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 Anesthesiology

Zip code


Address

4-5-10 Higashiyukigaya, Ota-ku, Tokyo, Japan

TEL

03-5734-8000

Homepage URL


Email

yuusuke-ubukata1@tokyo-hmt.jp


Sponsor or person

Institute

Department of Anesthesiology, Ebara Hospital

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


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

2017 Year 05 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

Completed

Date of protocol fixation

2017 Year 04 Month 14 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030995


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name