UMIN-CTR Clinical Trial

Basic information
Public title	Researching accuracy of Stroke Volume Variation (SVV) in spontaneous breathing
Acronym	Researching accuracy of SVV in spontaneous breathing
Scientific Title	Researching accuracy of Stroke Volume Variation (SVV) in spontaneous breathing
Scientific Title:Acronym	Researching accuracy of SVV in spontaneous breathing
Region	Japan

Condition
Condition	Abdominal Aortic Aneurysm
Classification by specialty	Vascular surgery Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We research that patients monitoring with Flo Trac system can measure accurate SVV in spontaneous breathing.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Difference of SVV between positive pressure ventilation and 6 times/min , 15 times/min spontaneous breathing
Key secondary outcomes	Difference of SVV between 15 times/min spontaneous breathing and 6 times/min spontaneous breathing

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	Targets are 20 years of age or older patients doing elective surgery of abdominal aortic aneurysm. Operation is branch type artificial blood vessel replacement surgery. These patients monitor with Flo Trac system.
Key exclusion criteria	Patients with moderate or severe aortic valve stenosis or moderate or severe mitral valve regurgitation or intra-aortic balloon pimping or percutaneous cardiopulmonary support or ventricular assist device.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Hiroaki Middle name Last name Toyama
Organization	Tohoku University Hospital
Division name	Anesthesiology
Zip code	980-8574
Address	Seiryomachi, Aoba-ku Sendai-shi, Miyagi, 980-8574
TEL	022-717-7321
Email	toru.tamii.b6@tohoku.ac.jp

Public contact
Name of contact person	1st name Toru Middle name Last name Tamii
Organization	Tohoku University Hospital
Division name	Anesthesiology
Zip code	980-8574
Address	Seiryomachi, Aoba-ku Sendai-shi, Miyagi, 980-8574
TEL	022-717-7321
Homepage URL
Email	rg7.db10.zz10@gmail.com

Sponsor
Institute	Tohoku University Hospital
Institute
Department

Funding Source
Organization	Tohoku University Hospital
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	Tohoku University Hospital
Address	Seiryomachi, Aoba-ku Sendai-shi, Miyagi, 980-8574
Tel	022-717-7321
Email	rg7.db10.zz10@gmail.com

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	2016 Year 06 Month 08 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	2016 Year 05 Month 13 Day
Date of IRB	2016 Year 06 Month 08 Day
Anticipated trial start date	2016 Year 06 Month 09 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	None notices

Management information
Registered date	2016 Year 06 Month 08 Day
Last modified on	2022 Year 06 Month 13 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026106