UMIN-CTR Clinical Trial

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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036401