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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034891
Receipt No. R000037357
Scientific Title Analysis of factors influencing pulmonary artery cathere passage of tricuspid valve and pulmonary valve.
Date of disclosure of the study information 2018/11/14
Last modified on 2018/11/14

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Basic information
Public title Analysis of factors influencing pulmonary artery cathere passage of tricuspid valve and pulmonary valve.
Acronym Analysis of facotors influencing pulmonary artery catheter placement
Scientific Title Analysis of factors influencing pulmonary artery cathere passage of tricuspid valve and pulmonary valve.
Scientific Title:Acronym Analysis of facotors influencing pulmonary artery catheter placement
Region
Japan

Condition
Condition Patients undegoing cardio-vascluar suregeries.
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To analyze facotrs influencing pulmonary artery catheter placement.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase

Assessment
Primary outcomes Time required to pass the tricuspid and pulmonary artery valve and facoters and factors influencing the time.
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 Ptients undergong cardiovacular surgery and requiring placemant of pulmolnary artery catherter.
Key exclusion criteria Patients with history of tricupid valve annnulo-plasty
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yukio Hayashi
Organization Sakurabashi-Watanabe Hospital
Division name Anesthesiology Service
Zip code
Address 2-4-32, Umeda, Kita-ku, Osaka, JAPAN
TEL 06-6341-8651
Email yhayashi@anes.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yukio Hayashi
Organization Sakurabashi- Watanabe Hospital
Division name Anesthesiology
Zip code
Address 2-4-32, Umeda, Kita-ku, Osaka, JAPAN
TEL 06-6341-8651
Homepage URL
Email yhayashi@anes.med.osaka-u.ac.jp

Sponsor
Institute Sakurabashi-Watanabe 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
2018 Year 11 Month 14 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
2017 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information none

Management information
Registered date
2018 Year 11 Month 14 Day
Last modified on
2018 Year 11 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037357

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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