UMIN-CTR Clinical Trial

Basic information
Public title	Cerebral oxygenation saturation in childhood-difference by age and model of near infrared spectroscopy
Acronym	Cerebral oxygenation saturation in childhood
Scientific Title	Cerebral oxygenation saturation in childhood-difference by age and model of near infrared spectroscopy
Scientific Title:Acronym	Cerebral oxygenation saturation in childhood
Region	Japan

Condition
Condition	Patients scheduled to have general anesthesia
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the difference of a brain oxygen saturation between children under 1 year old, 1-6, and 7-12 years old using both INVOS5100 and tNIRS-1. The Difference was also compared between the two devices.
Basic objectives2	Others
Basic objectives -Others	Search of the physiological changes
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	difference of rSO2 in each age of patient
Key secondary outcomes	difference of rSO2 between the two devices

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	Not applicable
Age-upper limit	12 years-old >=
Gender	Male and Female
Key inclusion criteria	1)Patients who are in ASA 1-2 and scheduled surgery under general anesthesia at Hokkaido University hospital. 2)Patients who are measured about hemoglobin consentration by blood inspection within a week before operation. 3)Written consent has been obtained by the parents concerning research participation.
Key exclusion criteria	1)Patients with brain, cardiovascular, or respiratory disease. 2)Patients who are bleeding or terrible anemia.
Target sample size	78

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yuji Morimoto
Organization	Hokkaido University Hospital
Division name	Department of Anesthesiology
Zip code
Address	Kita-ku N14 W5, Sapporo, Hokkaido, 060-8648, Japan
TEL	+81-11-706-5732
Email	morim2@med.hokudai.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Yasunori Kubo
Organization	Hokkaido University Hospital
Division name	Department of Anesthesiology
Zip code
Address	Kita-ku N14 W5, Sapporo, Hokkaido, 060-8648, Japan
TEL	+81-11-706-5732
Homepage URL
Email	yasu-kubo@mvd.biglobe.ne.jp

Sponsor
Institute	Department of Anesthesiology,Hokkaido University Hospital
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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	北海道大学病院(北海道)

Other administrative information
Date of disclosure of the study information	2018 Year 01 Month 15 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 11 Month 09 Day
Date of IRB	2017 Year 12 Month 15 Day
Anticipated trial start date	2017 Year 12 Month 15 Day
Last follow-up date	2019 Year 05 Month 31 Day
Date of closure to data entry	2019 Year 05 Month 31 Day
Date trial data considered complete	2019 Year 05 Month 31 Day
Date analysis concluded	2019 Year 05 Month 31 Day

Other
Other related information	Prospective observational study Observational items: Background, laboratory data, vital signs during operation, regional cerebral oxygenation index

Management information
Registered date	2018 Year 01 Month 14 Day
Last modified on	2019 Year 06 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035170