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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018103
Receipt No. R000020959
Scientific Title Predictor of longterm outcome in patients who have prolonged mechanical ventilation after cardiac surgery.
Date of disclosure of the study information 2015/06/30
Last modified on 2016/12/27

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Basic information
Public title Predictor of longterm outcome in patients who have prolonged mechanical ventilation after cardiac surgery.
Acronym Strategy of respiratory management and transfusion therapy
Scientific Title Predictor of longterm outcome in patients who have prolonged mechanical ventilation after cardiac surgery.
Scientific Title:Acronym Strategy of respiratory management and transfusion therapy
Region
Japan

Condition
Condition Cardiac surgical patients
Classification by specialty
Anesthesiology Cardiovascular surgery Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of present study is assessment of usefulness of minitracheostomy for one year mortality and preventable extubation failure in cardiac patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes one year mortality after surgery
Key secondary outcomes Duration of ventilation, intensive care unit, hospital stay

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

Not applicable
Gender Male and Female
Key inclusion criteria We enrolled cardiac surgical patients who admitted intensive care unit after operation.
Key exclusion criteria We excluded patients who were less than 18 y old, insufficient data.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name shunsuke takaki
Organization Yokohama City University
Division name Intensive Care Unit
Zip code
Address 3-9 Fukuura Kanazawaku Yokohama
TEL 045-787-2918
Email shunty5323@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name shunsuke takaki
Organization Yokohama City University
Division name Intensive Care Medicine
Zip code
Address 3-9 Fukuura Kanazawaku Yokohama
TEL 045-787-2918
Homepage URL
Email shunty5323@gmail.com

Sponsor
Institute Yokohama City University Department of Anesthesiology
Institute
Department

Funding Source
Organization Yokohama City University Department of Anesthesiology
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
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 横浜市立大学附属病院、横浜市立大学市民総合医療センター
Yokohama City University Hospital, Yokohama City University Medical Center

Other administrative information
Date of disclosure of the study information
2015 Year 06 Month 30 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Minitracheostomy after cardiac surgery decreased length of ICU stay and hospital stay. However, one year survival of patients who performed minitracheostomy was not significantly difference compared to patients with tracheostomy.  
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
2015 Year 06 Month 27 Day
Date of IRB
Anticipated trial start date
2015 Year 06 Month 30 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Transfusion strategy of Hct > 30% at the end of surgery improved patients mortality compared to those Hct < 30%.

In the prolonged mechanical ventilation after cardiac surgery, Higher hematocrit which could transport sufficient oxygen to the tissue may be useful strategy.

Management information
Registered date
2015 Year 06 Month 26 Day
Last modified on
2016 Year 12 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020959

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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