UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026521 |
|---|---|
| Receipt number | R000021566 |
| Scientific Title | A randomized clinical trial of the disposable oral care kit for preventing ventilator-associated pneumonia. |
| Date of disclosure of the study information | 2017/03/13 |
| Last modified on | 2017/03/13 11:06:40 |
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Basic information
Public title
A randomized clinical trial of the disposable oral care kit for preventing ventilator-associated pneumonia.
Acronym
A randomized clinical trial of the disposable oral care kit for preventing ventilator-associated pneumonia.
Scientific Title
A randomized clinical trial of the disposable oral care kit for preventing ventilator-associated pneumonia.
Scientific Title:Acronym
A randomized clinical trial of the disposable oral care kit for preventing ventilator-associated pneumonia.
Region
| Japan |
Condition
Condition
ventilator-associated pneumonia
Classification by specialty
| Intensive care medicine | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
--
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
CPIS
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
disposable oral care
Interventions/Control_2
toothbrush and swab
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
--
Key exclusion criteria
--
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiromitsu Kishimoto |
Organization
Hyogo College of Medicine
Division name
Dental and Oral Surgery
Zip code
Address
1-1,Mukogawa,Nishinomiya-city,HYOGO,JAPAN
TEL
0798-45-6510
kadoi@dd.iij4u.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | kanenori kadoi |
Organization
Hyogo College of Medicine
Division name
Department of Emergency and Critical Care Medicine
Zip code
Address
1-1,Mukogawa,Nishinomiya-city,HYOGO,JAPAN
TEL
0798-45-6510
Homepage URL
kadoi@dd.iij4u.or.jp
Sponsor or person
Institute
Hyogo College of Medicine
Institute
Department
Personal name
Funding Source
Organization
NIPRO
Organization
Division
Category of Funding Organization
Profit organization
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
| 2017 | Year | 03 | Month | 13 | 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
No longer recruiting
Date of protocol fixation
| 2014 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 08 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 03 | Month | 13 | Day |
Last modified on
| 2017 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021566
