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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031882
Receipt No. 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 2021/04/08

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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
Email 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
Email mako_sapmed@yahoo.co.jp

Sponsor
Institute Hokkaido Medical Center for Child Health and Rehabilitation
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 Hokkaido Medical Center for Child Health and Rehabilitation
Address Kanayama 1-1-240-6,Teine-ku,Sapporo,Hokkaido
Tel 011-691-5696
Email 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 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 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 04 Month 08 Day


Link to view the page
URL(English) https://upload.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


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