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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000028307
Receipt No. R000032402
Scientific Title The study of oral care methods of mechanically ventilated patients:prospective intervention study
Date of disclosure of the study information 2017/09/01
Last modified on 2017/07/20

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Basic information
Public title The study of oral care methods of mechanically ventilated patients:prospective intervention study
Acronym oral care of mechanically ventilated patients
Scientific Title The study of oral care methods of mechanically ventilated patients:prospective intervention study
Scientific Title:Acronym oral care of mechanically ventilated patients
Region
Japan

Condition
Condition ventilator-associated pneumonia(VAP)
Classification by specialty
Pneumology Infectious disease Intensive care medicine
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the efficacy of the oral care methods, removal of tongue coating and using antiseptic after irrigation of oral cavity, in mechanically ventilated patients
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The total number of bacteria in the oropharyngeal fluid
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
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 intervention:removal of tongue coating by using 3% hydrogen peroxide
Interventions/Control_2 intervention:removal of tongue coating by using 3% hydrogen peroxide, next 5ml of 10% povidone iodine is dropped in oropharynx after irrigation
Interventions/Control_3 intervention:removal of tongue coating by using 3% hydrogen peroxide, next 5ml of 0.05% chlorhexidine is dropped in oropharynx after irrigation
Interventions/Control_4 control:general oral care in ICU
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 mechanically ventilated patients in ICU
Key exclusion criteria 1. patinets who is difficult to doing oral care because of getting worse in general condition
2. patients who have allergy to used antiseptic
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Saki hayashida
Organization Nagasaki university hospital
Division name Oral and maxillofacial surgery
Zip code
Address 1-7-1 Sakamoto, Nagasaki 852-8588, Japan
TEL 095-819-7698
Email sakihaya@nagasaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Saki hayashida
Organization Nagasaki university hospital
Division name Oral and maxillofacial surgery
Zip code
Address 1-7-1 Sakamoto, Nagasaki 852-8588, Japan
TEL 095-819-7698
Homepage URL
Email sakihaya@nagasaki-u.ac.jp

Sponsor
Institute Nagasaki university hospital
Institute
Department

Funding Source
Organization self
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
Email

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 09 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 Preinitiation
Date of protocol fixation
2017 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 09 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 07 Month 20 Day
Last modified on
2017 Year 07 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032402

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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