UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003553 |
|---|---|
| Receipt number | R000004290 |
| Scientific Title | Continuous versus intermittent subglottic drainage for preventing ventilator-associated pneumonia in patients requiring mechanical ventilation:Single-center randomized controlled study. |
| Date of disclosure of the study information | 2010/05/01 |
| Last modified on | 2013/04/02 15:29:57 |
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Basic information
Public title
Continuous versus intermittent subglottic drainage for preventing ventilator-associated pneumonia in patients requiring mechanical ventilation:Single-center randomized controlled study.
Acronym
Continuous versus intermittent subglottic drainage for preventing ventilator-associated pneumonia in patients requiring mechanical ventilation:Single-center randomized controlled study.
Scientific Title
Continuous versus intermittent subglottic drainage for preventing ventilator-associated pneumonia in patients requiring mechanical ventilation:Single-center randomized controlled study.
Scientific Title:Acronym
Continuous versus intermittent subglottic drainage for preventing ventilator-associated pneumonia in patients requiring mechanical ventilation:Single-center randomized controlled study.
Region
| Japan |
Condition
Condition
Adult patients who is expected to undergo mechanical ventilation for more than 48 hours.
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy of continuous subglottic drainage in preventing ventilator-associated pneumonia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence of ventilator-associated pneumonia.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
continuous group:
continuous subglottic drainage
Interventions/Control_2
intermittent group:
intermittent subglottic drainage
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
Patients who is expected to undergo mechanical ventilation for more than 48 hours at Yokohama City University Medical Center General Intensive Care Unit.
Key exclusion criteria
Patients with pneumonia
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hajime Hayami |
Organization
Yokohama City University Medical Center
Division name
General Intensive Care Unit
Zip code
Address
4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL
045-261-5656
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroko Fujimoto |
Organization
Yokohama City University Medical Center
Division name
General Intensive Care Unit
Zip code
Address
4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL
045-261-5656
Homepage URL
Sponsor or person
Institute
Yokohama City University Medical Center
General Intensive Care Unit
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
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
横浜市立大学附属市民総合医療センター（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 05 | Month | 01 | 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
| 2010 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 04 | Month | 30 | Day |
Last modified on
| 2013 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004290
