UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022660
Receipt number R000026106
Scientific Title Researching accuracy of Stroke Volume Variation (SVV) in spontaneous breathing
Date of disclosure of the study information 2016/06/08
Last modified on 2022/06/13 12:25:34

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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 or person

Institute

Tohoku University Hospital

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026106


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name