UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039540 |
|---|---|
| Receipt number | R000044908 |
| Scientific Title | Cerebral oxygen saturation during arthroscopic shoulder surgery in beach chair position ver.2 |
| Date of disclosure of the study information | 2020/03/01 |
| Last modified on | 2022/02/23 07:20:56 |
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Basic information
Public title
Cerebral oxygen saturation during arthroscopic shoulder surgery in beach chair position ver.2
Acronym
Cerebral oxygen saturation during arthroscopic shoulder surgery in beach chair position ver.2
Scientific Title
Cerebral oxygen saturation during arthroscopic shoulder surgery in beach chair position ver.2
Scientific Title:Acronym
Cerebral oxygen saturation during arthroscopic shoulder surgery in beach chair position ver.2
Region
| Japan |
Condition
Condition
Patients schedules to have arthroscopic shoulder surgery
Classification by specialty
| Orthopedics | 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 tNIRS-1
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
Comparison of changes in cerebral oxygen saturation by beach chair position between awake and anesthetic state
Comparison of changes in cerebral oxygenation between the sides without brachial plexus block
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
Patients who have arthroscopic shoulder surgery under general anesthesia in the beach chair position at Hokkaido University Hospital
Key exclusion criteria
1 ASA-PS 3,4,5
2 Patients with cerebrovascular disease
3 Patients with cardiac failure above NYHA 3
4 Patients who is not applicable for the brachial plexus block
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Morimoto |
| Middle name | |
| Last name | Yuji |
Organization
Hokkaido University Hospital
Division name
Anesthesiology
Zip code
0608648
Address
N14 W5, Kita-ku, Sapporo
TEL
011-716-1161
morim2@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Itosu |
| Middle name | |
| Last name | Yusuke |
Organization
Hokkaido University Hospital
Division name
Anesthesiology
Zip code
0608648
Address
N14 W5, Kita-ku, Sapporo
TEL
011-716-1161
Homepage URL
itosu831@yahoo.co.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
Hokkaido University Hospital Division of Clinical Research Administration
Address
N14 W4, 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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 03 | 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
Terminated
Date of protocol fixation
| 2020 | Year | 01 | Month | 22 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 05 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 02 | Day |
Last follow-up date
| 2022 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study
Study period: until 2022.2.28
Patients who have arthroscopic shoulder surgery under general anesthesia in the beach chair position at the Hokkaido University Hospital and meet the criteria
Observational items: Patient's background, laboratory data, vital signs, cerebral hemoglobin concentration(Cerebral oxygenation)
Management information
Registered date
| 2020 | Year | 02 | Month | 20 | Day |
Last modified on
| 2022 | Year | 02 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044908
