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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000037508
Receipt No. 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

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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
Institute Asahikawa medical University
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)

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
URL(English) https://upload.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


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