UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Proper position with surgical cannulation of the inferior vena cava using transesophageal echocardiography in patients who underwent congenital heart disease repair.
Title of the study (Brief title)	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	Nobuko Ohashi
Organization	Niigata University Graduate School of Medical and Dental Sciences
Division name	Anesthesiology
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	Nobuko Ohashi
Organization	Niigata University Graduate School of Medical and Dental Sciences
Division name	Anesthesiology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 01 Month 09 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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