UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026614 |
|---|---|
| Receipt number | R000030567 |
| Scientific Title | Risk factor analysis for postoperative nausea and vomiting in patients undergoing transcatheter aortic valve implantation. |
| Date of disclosure of the study information | 2017/03/20 |
| Last modified on | 2020/03/23 20:19:54 |
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Basic information
Public title
Risk factor analysis for postoperative nausea and vomiting in patients undergoing transcatheter aortic valve implantation.
Acronym
Risk factor analysis for postoperative nausea and vomiting in patients undergoing transcatheter aortic valve implantation.
Scientific Title
Risk factor analysis for postoperative nausea and vomiting in patients undergoing transcatheter aortic valve implantation.
Scientific Title:Acronym
Risk factor analysis for postoperative nausea and vomiting in patients undergoing transcatheter aortic valve implantation.
Region
| Japan |
Condition
Condition
postoperative nausea and vomiting
Classification by specialty
| Surgery in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to identify the risk factors for PONV undergoing TAVI.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postoperative nausea and vomiting within 24h after surgery
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 who performed tranfemoral TAVI between January 2016 and February 2017 under general anesthesia in Osaka City University Hospital.
Key exclusion criteria
Patients who could not be extubeted in the operating room.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Tokihiro |
| Middle name | |
| Last name | Yamada |
Organization
Osaka City University Graduate School of Medicine
Division name
Anesthesiology
Zip code
5458586
Address
1-5-7, Asahimachi, Abeno-ku, Osaka 545-8585 Japan
TEL
06-6645-2186
anesth@med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Juri |
Organization
Osaka City University Graduate School of Medicine
Division name
Anesthesiology
Zip code
5458586
Address
1-5-7, Asahimachi, Abeno-ku, Osaka 545-8585 Japan
TEL
06-6645-2186
Homepage URL
anesth@med.osaka-cu.ac.jp
Sponsor or person
Institute
Osaka City University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Osaka City University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Osaka City University Graduate School of Medicine
Address
1-5-7, Asahimachi, Abeno-ku, Osaka 545-8586 Japan
Tel
81-6-6646-6125
ethics@med.osaka-cu.ac.jp
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
大阪市立大学病院(大阪府)
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 03 | Month | 20 | 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
| 2017 | Year | 01 | Month | 31 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We collect data related to postoperative nausea and vomiting from perioperative records of patients who performed TAVI. Multiple logistic regression analysis are performed using them.
Management information
Registered date
| 2017 | Year | 03 | Month | 20 | Day |
Last modified on
| 2020 | Year | 03 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030567
| Research Plan | |
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| 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 |
