UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026969 |
|---|---|
| Receipt number | R000030873 |
| Scientific Title | Oral Care Intervention Study for Ventilator-associated-pneumonia at Cho Ray Hospital in Ho Chi Minh City, Vietnam |
| Date of disclosure of the study information | 2017/05/01 |
| Last modified on | 2023/11/07 19:51:12 |
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Basic information
Public title
Oral Care Intervention Study for Ventilator-associated-pneumonia at Cho Ray Hospital in Ho Chi Minh City, Vietnam
Acronym
Oral Care Intervention Study for VAP
Scientific Title
Oral Care Intervention Study for Ventilator-associated-pneumonia at Cho Ray Hospital in Ho Chi Minh City, Vietnam
Scientific Title:Acronym
Oral Care Intervention Study for VAP
Region
| Asia(except Japan) |
Condition
Condition
Ventilator associated pneumonia
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the effects of the standard oral care intervention to HCW in the general ICU at CRH in Ho Chi Minh City, Vietnam
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
VAP cumulative incidence comparing before and after the standard oral care intervention
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
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom | Maneuver |
Interventions/Control_1
Dentists from NCGM trained for the standard oral care to local doctors and nurses in the general ICU at CRH in Ho Chi Minh City, Vietnam. After the oral care training phase (1 month), doctors and nurses in the general ICU at CRH performed the standard oral care to patients who fulfill the conditions of the disease and agree to participate in the study.
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The target who are received standard oral care are any patients who require the use of mechanical ventilator in the general ICU at CRH in Ho Chi Minh City, Vietnam
Key exclusion criteria
Any patients and their family members who do not agree or wish to be involved in this study.
The definition of VAP is a clinical diagnosis of pneumonia 48 hours and more after the initiation of mechanical ventilation. Based on the definition, the following patients are excluded:
-Patients who are extubated within 48 hours after the initiation of mechanical ventilation.
-Patients who die within 48 hours after the initiation of mechanical ventilation.
-Patients who are transferred to another ward from the general ICU at CRH within 48 hours after the initiation of mechanical ventilation.
-Patients who are transferred to another hospital from the general ICU at CRH within 48 hours after the initiation of mechanical ventilation.
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoshi Kutsuna |
Organization
National Center for Global Health and Medicine Hospital
Division name
Disease Control and Prevention Center
Zip code
Address
1-21-1 Toyama, Shinjuku-ku Tokyo, 162-8655
TEL
03-3202-7181
skutsuna@hosp.ncgm.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masahiro Ishikane |
Organization
National Center for Global Health and Medicine Hospital
Division name
Disease Control and Prevention Center
Zip code
Address
1-21-1 Toyama, Shinjuku-ku Tokyo, 162-8655
TEL
03-3202-7181
Homepage URL
mishikane@hosp.ncgm.go.jp
Sponsor or person
Institute
National Center for Global Health and Medicine Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development (AMED)
Organization
Division
Category of Funding Organization
Japanese Governmental office
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 | 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
| 2017 | Year | 02 | Month | 27 | Day |
Date of IRB
| 2017 | Year | 02 | Month | 26 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 11 | 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
| 2017 | Year | 04 | Month | 12 | Day |
Last modified on
| 2023 | Year | 11 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030873
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
