UMIN-CTR Clinical Trial

Basic information
Public title	Changes in cerebral circulation by beach chair position
Acronym	beach chair position and cerebral circulation
Scientific Title	Changes in cerebral circulation by beach chair position
Scientific Title:Acronym	beach chair position and cerebral circulation
Region	Japan

Condition
Condition	Patients scheduled to have shoulder arthroscopy in the beach chair position
Classification by specialty	Anesthesiology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To observe the changes in cerebral circulation during shoulder arthroscopy in the beach chair position
Basic objectives2	Others
Basic objectives -Others	Search of the physiological changes
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	changes in the cerebral blood flow and carotid artery blood flow before and after the beach chair position
Key secondary outcomes	changes in the cerebral saturation and cerebral blood volume before and after the beach chair position

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	1 Patients with ASA1 or 2
Key exclusion criteria	1 Patients with orthostatic hypotension 2 Patients with cerebrovascular disease
Target sample size	20

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
Email	morim2@med.hokudai.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Yusuke Itosu
Organization	Hokkaido University Hospital
Division name	Anesthesiology
Zip code
Address	N14 W5, Kita-ku, Sapporo
TEL	011-716-1161
Homepage URL
Email	itosu831@yahoo.co.jp

Sponsor
Institute	Hokkaido University Hospital Anesthesiology
Institute
Department

Funding Source
Organization	no
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
Email

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（北海道）

Other administrative information
Date of disclosure of the study information	2018 Year 12 Month 10 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	2018 Year 12 Month 05 Day
Date of IRB	2018 Year 12 Month 18 Day
Anticipated trial start date	2019 Year 01 Month 07 Day
Last follow-up date	2020 Year 06 Month 04 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 2020.6.4 Adult patients scheduled to have arthroscopic shoulder surgery in the beach chair position in the Hokkaido University Hospital anticipated numbers 20 Observational items: Background, laboratory data, vital signs, cerebral hemoglobin concentration , cerebral blood flow and carotid artery blood flow

Management information
Registered date	2018 Year 12 Month 04 Day
Last modified on	2019 Year 12 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038383