UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	An observation of cardiac function with transesophageal echocardiography during sitting-positioned neurosurgery.
Title of the study (Brief title)	An observation of cardiac function with transesophageal echocardiography during sitting-positioned neurosurgery.
Region	Japan

Condition
Condition	Patients who recieved neurosurgery in sitting position.
Classification by specialty	Anesthesiology Neurosurgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Hemodynamic effect of sitting position during neurosurgery is not well investigated. We investigate the hemodynamics during sitting neurosurgery with transesophageal echocardiography.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Cardiac function during sitting neurosurgery.
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	7 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who underwent neurosurgery in sitting position.
Key exclusion criteria	Patients for whom transesophageal echocardiography is contraindication.
Target sample size	30

Research contact person
Name of lead principal investigator	Hiroki Iida
Organization	Gifu University Graduate School of Medicine
Division name	Department of Anesthesiology and Pain Medicine
Address	1-1 Yanagido, Gifu, Gifu 501-1194, Japan
TEL	+81-58-230-6404
Email	iida@gifu-u.ac.jp

Public contact
Name of contact person	Kimito Minami
Organization	Gifu University Graduate School of Medicine
Division name	Department of Anesthesiology and Pain Medicine
Address	1-1 Yanagido, Gifu, Gifu, Japan
TEL	+81-58-230-6404
Homepage URL
Email	nann_5115@ybb.ne.jp

Sponsor
Institute	Gifu University Graduate School of Medicine, Department of Anesthesiology and Pain Medicine
Institute
Department

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)

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	2014 Year 10 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 08 Month 12 Day
Anticipated trial start date	2014 Year 10 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Investigate cardiac function of the patients who underwent neurosurgery in sitting position.

Management information
Registered date	2014 Year 08 Month 12 Day
Last modified on	2017 Year 08 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017244