UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031882 |
|---|---|
| Receipt number | R000036401 |
| Scientific Title | Anesthetic management of One-lung ventilation in Children undergoing Atrial Septal Defect closure on Lateral thoracotomy |
| Date of disclosure of the study information | 2018/03/24 |
| Last modified on | 2021/10/28 01:08:25 |
* 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
Anesthetic management of One-lung ventilation in Children undergoing Atrial Septal Defect closure on Lateral thoracotomy
Acronym
Anesthetic management of One-lung ventilation in Children undergoing Atrial Septal Defect closure on Lateral thoracotomy
Scientific Title
Anesthetic management of One-lung ventilation in Children undergoing Atrial Septal Defect closure on Lateral thoracotomy
Scientific Title:Acronym
Anesthetic management of One-lung ventilation in Children undergoing Atrial Septal Defect closure on Lateral thoracotomy
Region
| Japan |
Condition
Condition
Pediatric diseases
Classification by specialty
| Pediatrics | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Asses the management of One-lung ventilation in Children
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Management of One-lung ventilation
Key secondary outcomes
Relationship with One-lung ventilation and pulmonary circulation in congenital heart disease
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
| 1 | years-old | <= |
Age-upper limit
| 20 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Children who undergo Atrial Septal Defect closure on Lateral thoracotomy from April 1, 2014 to September 30, 2017.
Key exclusion criteria
None
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yuko |
| Middle name | |
| Last name | Nawa |
Organization
Hokkaido Medical Center for Child Health and Rehabilitation
Division name
Anesthesiology
Zip code
006-0041
Address
240-6,1-1 kanayama,Teine-ku,Sapporo,Hokkaido
TEL
011-691-5696
nawa@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Kemmochi |
Organization
KKR Sapporo Medical Center, Sapporo, Japan.
Division name
Anesthesiology
Zip code
062-0931
Address
6-3-40 Hiragishi 1-jo Toyohira-ku Sapporo-shi Hokkaido Japan 062-0931
TEL
011-822-1811
Homepage URL
http://www.pref.hokkaido.lg.jp/db/hkr/bunrihaikankinomasuikanri.pdf
mako_sapmed@yahoo.co.jp
Sponsor or person
Institute
Hokkaido Medical Center for Child Health and Rehabilitation
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
Hokkaido Medical Center for Child Health and Rehabilitation
Address
Kanayama 1-1-240-6,Teine-ku,Sapporo,Hokkaido
Tel
011-691-5696
mako_sapmed@yahoo.co.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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 03 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
37
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 | 09 | Month | 30 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 25 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 25 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Asses the management of One-lung ventilation in Children who undergo Atrial Septal Defect closure on Lateral thoracotomy from April 1, 2014 to September 30, 2017.
Management information
Registered date
| 2018 | Year | 03 | Month | 24 | Day |
Last modified on
| 2021 | Year | 10 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036401
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
