UMIN-CTR Clinical Trial

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
Email	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
Email	anesth@med.osaka-cu.ac.jp

Sponsor
Institute	Osaka City University Graduate School of Medicine
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030567