UMIN-CTR Clinical Trial

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
Email	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
Email	kumiko-t@m2.gyao.ne.jp

Sponsor
Institute	Gifu University Graduate School of Medicine
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019902