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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025581
Receipt No. R000029439
Scientific Title Proper position with surgical cannulation of the inferior vena cava using transesophageal echocardiography in patients who underwent congenital heart disease repair.
Date of disclosure of the study information 2017/01/09
Last modified on 2017/10/27

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Basic information
Public title Proper position with surgical cannulation of the inferior vena cava using transesophageal echocardiography in patients who underwent congenital heart disease repair.
Acronym Proper position with cannulation of the inferior vena cava
Scientific Title Proper position with surgical cannulation of the inferior vena cava using transesophageal echocardiography in patients who underwent congenital heart disease repair.
Scientific Title:Acronym Proper position with cannulation of the inferior vena cava
Region
Japan

Condition
Condition pediatric patients who underwent congenital heart disease repair.
Classification by specialty
Vascular surgery Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Examination of proper position in cannula to inferior vena cava using transesophageal echocardiography with congenital heart disease surgery
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes perfusion volume of cardiopulmonary bypass with respect to the perfusion index
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 proximal group
Interventions/Control_2 distal group
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
0 years-old <=
Age-upper limit
6 years-old >
Gender Male and Female
Key inclusion criteria pediatric patients with congenital heart disease using cardiopulmonary bypass
Key exclusion criteria over the 15 kg of weight
inferior vena cava abnormality
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nobuko Ohashi
Organization Niigata University Graduate School of Medical and Dental Sciences
Division name Anesthesiology
Zip code
Address 1-757 Asahimachi Dori, Chuo-Ku, Niigata City, 951-8510 Japan
TEL +81-25-227-2328
Email ww81854@sa2.so-net.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Nobuko Ohashi
Organization Niigata University Graduate School of Medical and Dental Sciences
Division name Anesthesiology
Zip code
Address 1-757 Asahimachi Dori, Chuo-Ku, Niigata City, 951-8510 Japan
TEL +81-25-227-2328
Homepage URL
Email ww81854@sa2.so-net.ne.jp

Sponsor
Institute Niigata University Graduate School of Medical and Dental Sciences
Institute
Department

Funding Source
Organization none
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
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
2017 Year 01 Month 09 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 09 Day
Date of IRB
Anticipated trial start date
2017 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

Management information
Registered date
2017 Year 01 Month 09 Day
Last modified on
2017 Year 10 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029439

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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