UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027199 |
|---|---|
| Receipt number | R000031079 |
| Scientific Title | Changes in cerebral oxygen saturation during arthroscopic shoulder surgery in beach chair position |
| Date of disclosure of the study information | 2017/05/01 |
| Last modified on | 2018/05/01 12:32:28 |
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Basic information
Public title
Changes in cerebral oxygen saturation during arthroscopic shoulder surgery in beach chair position
Acronym
Beach chair position and changes in cerebral oxygen saturation
Scientific Title
Changes in cerebral oxygen saturation during arthroscopic shoulder surgery in beach chair position
Scientific Title:Acronym
Beach chair position and changes in cerebral oxygen saturation
Region
| Japan |
Condition
Condition
Patients schedules to have arthroscopic shoulder surgery
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate a brain oxygen saturation change in the arthroscope shoulder surgery with the beach chair position using NIRO-200NX which can measure it with both spatial resolved and Lambert-Beer methods.
Basic objectives2
Others
Basic objectives -Others
Search of the physiological changes
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
brain oxygen saturation changes in the arthroscope shoulder surgery with the beach chair position
Key secondary outcomes
postoperative dementia and complications
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients with written informed consent
Key exclusion criteria
1 Patients with cerebrovascular disease
2 Patients orthostatic hypotension
3 ASA-PS 3,4,5
Target sample size
21
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuji Morimoto |
Organization
Hokkaido University Hospital
Division name
Anesthesiology
Zip code
Address
N14 W5, Kita-ku, Sapporo
TEL
011-716-1161
morim2@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuji Morimoto |
Organization
Hokkaido University Hospital
Division name
Anesthesiology
Zip code
Address
N14 W5, Kita-ku, Sapporo
TEL
011-716-1161
Homepage URL
morim2@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
Anesthesiology
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 05 | 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
| 2015 | Year | 06 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 11 | Month | 10 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study
Observational items: Background, laboratory data, vital signs during operation cerebral oxygenation, postoperative dementia and complications
Management information
Registered date
| 2017 | Year | 04 | Month | 30 | Day |
Last modified on
| 2018 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031079
