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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000019934
Receipt No. R000023016
Scientific Title Switching One-Lung and Two-Lung Ventilation by an Extra-Easy Simple Method.
Date of disclosure of the study information 2015/11/26
Last modified on 2015/12/12

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Basic information
Public title Switching One-Lung and Two-Lung Ventilation by an Extra-Easy Simple Method.
Acronym Switching One-Lung and Two-Lung Ventilation.
Scientific Title Switching One-Lung and Two-Lung Ventilation by an Extra-Easy Simple Method.
Scientific Title:Acronym Switching One-Lung and Two-Lung Ventilation.
Region
Japan

Condition
Condition Patients scheduled for lung surgery
Classification by specialty
Chest surgery Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Sometimes like massive air leak is apparent in the latter part of lung surgery, we have to switch OLV to TLV and vice versa in a short period of time to assist finding the site of leak and sealing the origin of it. In such occasions, attaching simple adaptor will offset complicated process of exchanging OLV and TLV.
The purpose of this study is to demonstrate the safety, efficacy and user-friendliness of this adaptor.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Check the time requiring switching one lung ventilation to two lung ventilation and vice versa.
The safety, efficacy and user-friendliness of this adaptor will evaluate with a questionnaire answered by an anesthesiologist who charges in this study.


Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 Measuring the time to change OLV to TLV and TLV to OLV, in the situation when adaptor is attached or not.
This measure is planned before the surgery is started.
After this adaptor is attached, smoothness of exchanging OLV to TLV or vice versa and any issue related attaching this adaptor are asked by filling out some questionnaires.

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 1) Patients scheduled for lung surgery with double-lumen endobronchial tube.
2) Patients with 20 years or older.
Key exclusion criteria 1) Emergency cases.
2) Patients having a chronic respiratory failure or chronic obstructive lung disease.
3) Patients with critical cardiovascular illness.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Syozo Hidaka
Organization Japan Labour Health and Welfare Organization, Chugoku Rosai Hospital
Division name Department of Anesthessiology
Zip code
Address Hiro Tagaya 1-5-1, Kure, Hiroshima, Japan
TEL 0823-72-7171
Email hidakas@chugokuh.rofuku.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Syozo Hidaka
Organization Japan Labour Health and Welfare Organization, Chugoku Rosai Hospital
Division name Department of Anesthessiology
Zip code
Address Hiro Tagaya 1-5-1, Kure, Hiroshima, Japan
TEL 0823-72-7171
Homepage URL
Email hidakas@chugokuh.rofuku.go.jp

Sponsor
Institute Japan Labour Health and Welfare Organization, Chugoku Rosai Hospital
Institute
Department

Funding Source
Organization Japan Labour Health and Welfare Organization, Chugoku Rosai Hospital
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 中国労災病院(広島県)

Other administrative information
Date of disclosure of the study information
2015 Year 11 Month 26 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 Open public recruiting
Date of protocol fixation
2015 Year 10 Month 30 Day
Date of IRB
Anticipated trial start date
2015 Year 11 Month 01 Day
Last follow-up date
2016 Year 05 Month 01 Day
Date of closure to data entry
2016 Year 05 Month 01 Day
Date trial data considered complete
2016 Year 05 Month 31 Day
Date analysis concluded
2016 Year 05 Month 31 Day

Other
Other related information non

Management information
Registered date
2015 Year 11 Month 25 Day
Last modified on
2015 Year 12 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023016

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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