UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030441
Receipt number R000034756
Scientific Title Comparison of non-invasive continuous cardiac monitoring for thoracic aortic aneurysm surgery
Date of disclosure of the study information 2017/12/18
Last modified on 2019/05/26 22:13:28

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Basic information

Public title

Comparison of non-invasive continuous cardiac monitoring for thoracic aortic aneurysm surgery

Acronym

Non-invasive continuous cardiac monitoring comparison

Scientific Title

Comparison of non-invasive continuous cardiac monitoring for thoracic aortic aneurysm surgery

Scientific Title:Acronym

Non-invasive continuous cardiac monitoring comparison

Region

Japan


Condition

Condition

Thoracic aortic aneurysm

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Comparison of non-invasive cardiac output monitoring during thoracic aortic aneurysm surgery and post-cardiac surgery state in ICU

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

Evaluation the accuracy and trending ability of CCO, APCO, esCCO

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

Inclusion criteria is patients undergoing elective thoracic aortic aneurysm surgery performing PAC and APCO monitoring, age>20years old, mentally oriented and getting informed consent. for the study.

Key exclusion criteria

Exclusion criteria: patients without informed consent, who is difficult to insert arterial pressure line, change of surgical procedure, re-do operation, emergency surgery, who is intubated, IABP insertion, Pacemaker insertion, and who cannot insert pulmonary aortic catheter.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Misa Kajitani

Organization

Kawasaki Saiwai Hospital

Division name

Department of anesthesiology

Zip code


Address

31-27 Omiyacho, Saiwai-ku, Kawasaki, Kanagawa, Japan

TEL

044-544-4611

Email

misa@yj8.so-net.ne.jp


Public contact

Name of contact person

1st name
Middle name
Last name Misa Kajitani

Organization

Kawasaki saiwai hospital

Division name

Department of anesthesiology

Zip code


Address

31-27 Omiyacho, Saiwai-ku, Kawasaki, Kanagawa, Japan

TEL

044-544-4611

Homepage URL


Email

misa@yj8.so-net.ne.jp


Sponsor or person

Institute

Kawasaki saiwai hosipital

Institute

Department

Personal name



Funding Source

Organization

Kawasaki saiwai 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


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



Other administrative information

Date of disclosure of the study information

2017 Year 12 Month 18 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

Completed

Date of protocol fixation

2017 Year 12 Month 01 Day

Date of IRB

2017 Year 04 Month 27 Day

Anticipated trial start date

2017 Year 10 Month 01 Day

Last follow-up date

2018 Year 04 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Observational study


Management information

Registered date

2017 Year 12 Month 18 Day

Last modified on

2019 Year 05 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034756


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name