UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037508
Receipt number R000042753
Scientific Title Minimally Invasive Awake Mitral Valve Surgery and Cardiopulmonary Bypass Without General Anesthesia
Date of disclosure of the study information 2019/07/27
Last modified on 2020/06/02 09:54:18

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Basic information

Public title

Minimally Invasive Awake Mitral Valve Surgery and Cardiopulmonary Bypass Without General Anesthesia

Acronym

Minimally Invasive Awake Mitral Valve Surgery and Cardiopulmonary Bypass Without General Anesthesia

Scientific Title

Minimally Invasive Awake Mitral Valve Surgery and Cardiopulmonary Bypass Without General Anesthesia

Scientific Title:Acronym

Minimally Invasive Awake Mitral Valve Surgery and Cardiopulmonary Bypass Without General Anesthesia

Region

Japan


Condition

Condition

mitral regurgitation, tricuspid regurgitation, atrial septal defect and cardiac tumor

Classification by specialty

Surgery in general Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this present study is to evaluate the mortality, the period of ICU stay between regional anesthesia and general anesthesia in minimum invasive cardiac surgery.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

morbidity

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

18 years-old <=

Age-upper limit

100 years-old >

Gender

Male and Female

Key inclusion criteria

Consecutive patients who underwent scheduled minimum invasive cardiac surgery were enrolled.

Key exclusion criteria

Severe cardiac hypofunction and refusal to participate.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Hirotsugu
Middle name
Last name Kanda

Organization

Asahikawa medical University

Division name

Department of Anesthesiology and Critical Care Medicine

Zip code

078-8510

Address

Midorigaoka-higashi 2-1-1-1, Asahikawa, Hokkaido, 078-8510, Japan

TEL

0166-68-2583

Email

hirotsgukanda0629@gmail.com


Public contact

Name of contact person

1st name Hirotsugu
Middle name
Last name Kanda

Organization

Asahikawa medical University

Division name

Department of Anesthesiology and Critical Care Medicine

Zip code

078-8510

Address

Midorigaoka-higashi 2-1-1-1, Asahikawa, Hokkaido, 078-8510, Japan

TEL

0166-68-2583

Homepage URL


Email

hirotsgukanda0629@gmail.com


Sponsor or person

Institute

Asahikawa medical University

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization

Asahikawa Medical University Research Ethics Committee

Address

Midorigaoka-higashi 2-1-1-1, Asahikawa, Hokkaido, 078-8510, Japan

Tel

0166-68-2297

Email

rs-kk.g@asahikawa-med.ac.jp


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

2019 Year 07 Month 27 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

2014 Year 04 Month 01 Day

Date of IRB

2019 Year 06 Month 28 Day

Anticipated trial start date

2014 Year 04 Month 01 Day

Last follow-up date

2020 Year 03 Month 16 Day

Date of closure to data entry

2020 Year 03 Month 16 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information

None


Management information

Registered date

2019 Year 07 Month 27 Day

Last modified on

2020 Year 06 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042753


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name