UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019677 |
|---|---|
| Receipt number | R000022740 |
| Scientific Title | Establishment of an effective oral care to ventilator-associated pneumonia prevention |
| Date of disclosure of the study information | 2015/11/09 |
| Last modified on | 2022/11/15 17:23:40 |
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Basic information
Public title
Establishment of an effective oral care to ventilator-associated pneumonia prevention
Acronym
Establishment of an effective oral care to ventilator-associated pneumonia prevention
Scientific Title
Establishment of an effective oral care to ventilator-associated pneumonia prevention
Scientific Title:Acronym
Establishment of an effective oral care to ventilator-associated pneumonia prevention
Region
| Japan |
Condition
Condition
Patients in endotracheal intubation in the ER-ICU admission
Classification by specialty
| Nursing | Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigate the current oral care,and creates a protocil that can accommodate differences of more oral environment, to reduce the incidence of VAP
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Comparison of the number of oral bacteria before and after oral care
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Behavior,custom | Maneuver |
Interventions/Control_1
In intubated patients at the time of admission, when the oral care and went to the next day or the day, to count the number of bacteria in the mouth before and after
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
| 15 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients in endotracheal intuation in the ER-ICU admission
Key exclusion criteria
Patients with damage in the mouth
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | AKIKO MIZOE |
Organization
Tokyo Medical and Dental University Hospital
Division name
ER-ICU
Zip code
Address
Bunkyo-ku,Tokyo Yushima
TEL
03-5803-4783
0071mnrs@tmd.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | AKIKO MIZOE |
Organization
Tokyo Medical and Dental University Hospital
Division name
ER-ICU
Zip code
Address
Bunkyo-ku,Tokyo Yushima
TEL
03-5803-4783
Homepage URL
0071mnrs@tmd.co.jp
Sponsor or person
Institute
Tokyo Medical and Dental University Scool of Medicine Affairs multiplied
Institute
Department
Personal name
Funding Source
Organization
Nipro Corporation
Organization
Division
Category of Funding Organization
Other
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 11 | Month | 09 | 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
| 2015 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 05 | Month | 26 | Day |
Anticipated trial start date
| 2015 | Year | 05 | Month | 26 | Day |
Last follow-up date
| 2015 | Year | 11 | Month | 08 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 11 | Month | 08 | Day |
Last modified on
| 2022 | Year | 11 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022740
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
| 2017/05/15 | 集中治療医学会.pptx最新.pptx |
