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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016508
Receipt No. R000019172
Scientific Title The effect of oxygenation during left heart bypass undergoing aortic surgery via left thoracotomy approach
Date of disclosure of the study information 2015/02/11
Last modified on 2015/02/11

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Basic information
Public title The effect of oxygenation during left heart bypass undergoing aortic surgery via left thoracotomy approach
Acronym The mechanism of oxygenation during left heart bypass undergoing aortic surgery via left thoracotomy approach
Scientific Title The effect of oxygenation during left heart bypass undergoing aortic surgery via left thoracotomy approach
Scientific Title:Acronym The mechanism of oxygenation during left heart bypass undergoing aortic surgery via left thoracotomy approach
Region
Japan

Condition
Condition thoracic aortic aneurysms, thoracoabdominal aortic aneurysms
Classification by specialty
Anesthesiology Cardiovascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Partial left heart bypass (LHB) provides circulatory support for the surgical repair of distal arch, descending, and thoracoabdominal aortic aneurysms. Only one study reported improvement of data on oxygenation with LHB during one lung ventilation (OLV). However, the mechanism of oxygenation is unclear. Therefore, we evaluate arterial oxygenation with LHB during OLV and consider the mechanism of oxygenation.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes PaO2 with LHB during one lung ventilation
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria patients scheduled for aortic surgery via left thoracotomy approach using LHB as circulatory support
Key exclusion criteria patients not tolerated one-lung ventilation before institution of LHB
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name KIkuko Suga
Organization Kawasaki Municipal Hospital
Division name Anesthesiology
Zip code
Address 12-1 Shinkawadori Kawasaki-ku Kawasaki-shi Kanagawa-ken
TEL 044-233-5521
Email kikuko.suga@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Kikuko Suga
Organization Kawasaki Municipal Hospital
Division name Anesthesiology
Zip code
Address 12-1 Shinkawadori Kawasaki-ku Kawasaki-shi Kanagawa-ken
TEL 044-233-5521
Homepage URL
Email kikuko.suga@gmail.com

Sponsor
Institute Kawasaki Saiwai 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)

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
2015 Year 02 Month 11 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
2011 Year 12 Month 29 Day
Date of IRB
Anticipated trial start date
2012 Year 01 Month 09 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information measure PaO2 during surgery

Management information
Registered date
2015 Year 02 Month 11 Day
Last modified on
2015 Year 02 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019172

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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