UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018103 |
|---|---|
| Receipt number | 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 13:50:52 |
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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
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
shunty5323@gmail.com
Sponsor or person
Institute
Yokohama City University Department of Anesthesiology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020959
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
