UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012758
Receipt number R000014864
Scientific Title MDCT Predicts the Optimal Depth of Insertion of a Left Double lumen Endobronchial Tube
Date of disclosure of the study information 2014/02/01
Last modified on 2015/07/05 09:58:40

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Basic information

Public title

MDCT Predicts the Optimal Depth of Insertion of a Left Double lumen Endobronchial Tube

Acronym

Prediction of the Depth in Left Double lumen Endobronchial Tube

Scientific Title

MDCT Predicts the Optimal Depth of Insertion of a Left Double lumen Endobronchial Tube

Scientific Title:Acronym

Prediction of the Depth in Left Double lumen Endobronchial Tube

Region

Japan


Condition

Condition

lung cancer

Classification by specialty

Chest surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

to predict the optimal depth of insertion of double lumen endobronchial tubes

Basic objectives2

Others

Basic objectives -Others

safety

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

to evaluate the association between the true depth of insertion,which was calculated from MDCT

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


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


Not applicable

Gender

Male and Female

Key inclusion criteria

patient who was scheduled elective thoracic surgery with DLT

Key exclusion criteria

1 history of tracheal or laryngeal operation
2 pregnancy
3 under 20 years old
4 patient who was assessed inapopropriate

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takeshi Tateda

Organization

St. Marianna University School of Medicine

Division name

Anesthesiology

Zip code


Address

2-16-1,Sugao,Miyamae-ku,Kawasaki Kanagawa

TEL

044-977-8111

Email

t2tateda@mariannna-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Saori Tanigawa

Organization

St. Marianna University School of Medicine

Division name

Anesthesiology

Zip code


Address

2-16-1,Sugao,Miyamae-ku,Kawasaki Kanagawa

TEL

044-977-8111

Homepage URL


Email

fytdb494@yahoo.co.jp


Sponsor or person

Institute

St. Marianna University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

St. Marianna University School of Medicine

Organization

Division

Category of Funding Organization

Self funding

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

聖マリアンナ医科大学病院


Other administrative information

Date of disclosure of the study information

2014 Year 02 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

2013 Year 12 Month 21 Day

Date of IRB


Anticipated trial start date

2014 Year 02 Month 01 Day

Last follow-up date

2015 Year 03 Month 31 Day

Date of closure to data entry

2015 Year 04 Month 30 Day

Date trial data considered complete

2015 Year 05 Month 31 Day

Date analysis concluded

2016 Year 12 Month 31 Day


Other

Other related information

prospective study


Management information

Registered date

2014 Year 01 Month 05 Day

Last modified on

2015 Year 07 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014864


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name