UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033990 |
|---|---|
| Receipt number | 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 | 2022/09/06 14:40:33 |
* 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
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 | Yuji |
| Middle name | |
| Last name | MORIMOTO |
Organization
Hokkaido University Hospital
Division name
Department of anesthesiology
Zip code
060-8648
Address
N 14 W 5, kita-ku, Sapporo
TEL
011-716-1161
morim2@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Masataka |
| Middle name | |
| Last name | YAMAMOTO |
Organization
Hokkaido University Hospital
Division name
Department of anesthesiology
Zip code
060-8648
Address
N 14 W 5, kita-ku, Sapporo
TEL
011-716-1161
Homepage URL
m030044y@gmail.com
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
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
Hokkaido University Hospital IRB
Address
N14 W5, Kita-ku, Sapporo
Tel
011-706-7636
crjimu@huhp.hokudai.ac.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
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
Completed
Date of protocol fixation
| 2018 | Year | 08 | Month | 31 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 24 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 03 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
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
| 2022 | Year | 09 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038515
