UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025581 |
|---|---|
| Receipt number | 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 20:35:55 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
ww81854@sa2.so-net.ne.jp
Sponsor or person
Institute
Niigata University Graduate School of Medical and Dental Sciences
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029439
