UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030799 |
|---|---|
| Receipt number | R000035170 |
| Scientific Title | Cerebral oxygenation saturation in childhood-difference by age and model of near infrared spectroscopy |
| Date of disclosure of the study information | 2018/01/15 |
| Last modified on | 2019/06/13 10:11:47 |
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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
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
yasu-kubo@mvd.biglobe.ne.jp
Sponsor or person
Institute
Department of Anesthesiology,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
Address
Tel
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035170
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
