UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019934 |
|---|---|
| Receipt number | 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 22:45:31 |
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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
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
hidakas@chugokuh.rofuku.go.jp
Sponsor or person
Institute
Japan Labour Health and Welfare Organization, Chugoku Rosai Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023016
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
