UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016508 |
|---|---|
| Receipt number | 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 13:17:45 |
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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
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
kikuko.suga@gmail.com
Sponsor or person
Institute
Kawasaki Saiwai 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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019172
