UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053428 |
|---|---|
| Receipt number | R000060973 |
| Scientific Title | A prospective observational study of influence of surgical position on cerebral perfusion assessed by zero flow pressure measuring |
| Date of disclosure of the study information | 2024/01/24 |
| Last modified on | 2024/01/24 17:03:34 |
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Basic information
Public title
A prospective observational study of influence of surgical position on cerebral perfusion assessed by zero flow pressure measuring
Acronym
A prospective observational study of influence of surgical position on cerebral perfusion assessed by zero flow pressure measuring
Scientific Title
A prospective observational study of influence of surgical position on cerebral perfusion assessed by zero flow pressure measuring
Scientific Title:Acronym
A prospective observational study of influence of surgical position on cerebral perfusion assessed by zero flow pressure measuring
Region
| Japan |
Condition
Condition
Patients in sitting, prone or Trendelenburg position under general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will measure the zero flow pressure (effective downstream pressure) of the patients in sitting, prone or Trendelenburg position under general anesthesia. The aim of this study is to explore adequate blood pressure that can maintain cerebral perfusion of patients in sitting, prone or Trendelenburg position under general anesthesia.
Basic objectives2
Others
Basic objectives -Others
We will calculate cerebral perfusion pressure using zero flow pressure
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Difference in zero flow pressure caused by patient's position change
Key secondary outcomes
Cerebral perfusion pressure calculated by zero flow pressure
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients in sitting, prone or Trendelenburg position under general anesthesia
Key exclusion criteria
The patient with cerebrovascular disease
The patient who has a hemodialysis shunt on non-surgical side arm
The patient who cannot measure cerebral blood flow by transcranial doppler
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Hideo |
| Middle name | |
| Last name | Oka |
Organization
Japan Community Health care Organization Tokuyama Central Hospital
Division name
Department of Anesthesiology
Zip code
745-8522
Address
Koda-cho 1-1, Shunan City, Yamaguchi Prefecture, Japan
TEL
0834-28-4411
okabyouin@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Shunichi |
| Middle name | |
| Last name | Murakami |
Organization
Japan Community Health care Organization Tokuyama Central Hospital
Division name
Department of Anesthesiology
Zip code
745-8522
Address
Koda-cho 1-1, Shunan City, Yamaguchi Prefecture, Japan
TEL
0834-28-4411
Homepage URL
d007ubu@yamaguchi-u.ac.jp
Sponsor or person
Institute
Japan Community Health care Organization Tokuyama Central Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokuyama Central Hospital Ethics Committee
Address
Koda-cho 1-1, Shunan City, Yamaguchi Prefecture, Japan
Tel
0834-28-4411
irb-cr@tokuyama.jcho.go.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
独立行政法人地域医療機能推進機構徳山中央病院（山口県）、山口大学医学部附属病院（山口県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 01 | Month | 24 | 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
| 2024 | Year | 01 | Month | 11 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 11 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 18 | Day |
Last follow-up date
| 2025 | 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
After January 11th, 2024, patients (18-year-old or over) have an operation in sitting, prone or Trendelenburg position under general anesthesia at Tokuyama Central Hospital.
Management information
Registered date
| 2024 | Year | 01 | Month | 24 | Day |
Last modified on
| 2024 | Year | 01 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060973
| 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 |
