UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017158 |
|---|---|
| Receipt number | R000019902 |
| Scientific Title | Influences of cardiovascular function by beach chair position during arthroscopic shoulder surgery under general anesthesia |
| Date of disclosure of the study information | 2015/05/08 |
| Last modified on | 2019/06/12 13:07:58 |
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Basic information
Public title
Influences of cardiovascular function by beach chair position during arthroscopic shoulder surgery under general anesthesia
Acronym
beach chair position surgery
Scientific Title
Influences of cardiovascular function by beach chair position during arthroscopic shoulder surgery under general anesthesia
Scientific Title:Acronym
beach chair position surgery
Region
| Japan |
Condition
Condition
arthroscopic shoulder surgery
Classification by specialty
| Orthopedics | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In the beach chair position, patients may be at risk for cerebral ischemia. Therefore, anesthesiologists increase blood pressure in patients. However, the influences of the elevated blood pressure in the beach chair position for cardiac functions are not clarified.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We evaluated cardiovascular functions by Flo Trac.
Key secondary outcomes
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 undergoing shoulder surgery in the beach chair position under general anesthesia
Key exclusion criteria
none
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kumiko |
| Middle name | |
| Last name | Tanabe |
Organization
Gifu University Graduate School of Medicine
Division name
Anesthesiology and Pain Medicine
Zip code
501-1194
Address
Gifu City Yanagido 1-1
TEL
058-230-6404
kumiko-t@m2.gyao.ne.jp
Public contact
Name of contact person
| 1st name | Kumiko |
| Middle name | |
| Last name | Tanabe |
Organization
Gifu University Graduate School of Medicine
Division name
Anesthesiology and Pain Medicine
Zip code
501-1194
Address
Gifu City Yanagido 1-1
TEL
058-230-6404
Homepage URL
kumiko-t@m2.gyao.ne.jp
Sponsor or person
Institute
Gifu University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Gifu University Graduate School of Medicine
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
Gifu University Graduate School of Medicine
Address
Yanagido 1-1, Gifu City
Tel
058-230-6404
kumiko-t@m2.gyao.ne.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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 05 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Published
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 | 04 | Month | 08 | Day |
Date of IRB
| 2015 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2015 | Year | 04 | Month | 08 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2016 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2016 | Year | 12 | Month | 30 | Day |
Other
Other related information
Blood pressure, cardiac output, cardiac index, stroke volume, stroke volume index, stroke volume variation)
during surgery
Management information
Registered date
| 2015 | Year | 04 | Month | 17 | Day |
Last modified on
| 2019 | Year | 06 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019902
