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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033990
Receipt No. R000038515
Scientific Title The change of cerebral oxygen saturation in pediatric cardiac surgery
Date of disclosure of the study information 2018/09/01
Last modified on 2018/09/01

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Basic information
Public title The change of cerebral oxygen saturation in pediatric cardiac surgery
Acronym Cerebral oxygen saturation in pediatric cardiac surgery
Scientific Title The change of cerebral oxygen saturation in pediatric cardiac surgery
Scientific Title:Acronym Cerebral oxygen saturation in pediatric cardiac surgery
Region
Japan

Condition
Condition Congenital heart disease
Classification by specialty
Anesthesiology Cardiovascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We investigate the change of cerebral oxygen saturation using near infrared spectroscopy (NIRO-200NX or FORE-SIGHT ELITE).
Basic objectives2 Others
Basic objectives -Others Search of physiological changes (including cerebral blood flow and cerebral vascular resistance)
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changes of cerebral oxygen saturation and physiological parameter in pediatric cardiac surgery
Key secondary outcomes The difference between NIRO-200NX and FORE-SIGHT ELITE

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
15 years-old >=
Gender Male and Female
Key inclusion criteria The patients who have cardiac surgery at Hokkaido University Hospital
Key exclusion criteria None
Target sample size 200

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 N 14 W 5, kita-ku, Sapporo
TEL 011-716-1161
Email morim2@med.hokudai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masataka YAMAMOTO
Organization Hokkaido University Hospital
Division name Department of anesthesiology
Zip code
Address N 14 W 5, kita-ku, Sapporo
TEL 011-716-1161
Homepage URL
Email m030044y@gmail.com

Sponsor
Institute 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 09 Month 01 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 Enrolling by invitation
Date of protocol fixation
2018 Year 08 Month 31 Day
Date of IRB
Anticipated trial start date
2018 Year 09 Month 03 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Design: Prospective observational study
Last follow-up date: Mar 31, 2021
Subjects: Patients under the age of 15 who have cardiac surgery at Hokkaido University Hospital
Observational points: patients background, imaging examination, blood test, vital signs, cerebral oxygen saturation, cerebral blood flow, cerebral vascular resistance

Management information
Registered date
2018 Year 09 Month 01 Day
Last modified on
2018 Year 09 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038515

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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