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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000014693
Receipt No. R000017023
Scientific Title Development of oral care method without using water, for the purpose of prevention of sewage flow into the respiratory tract
Date of disclosure of the study information 2014/07/29
Last modified on 2014/09/16

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Basic information
Public title Development of oral care method without using water, for the purpose of prevention of sewage flow into the respiratory tract
Acronym Development of oral care method without using water, for the purpose of prevention of sewage flow into the respiratory tract
Scientific Title Development of oral care method without using water, for the purpose of prevention of sewage flow into the respiratory tract
Scientific Title:Acronym Development of oral care method without using water, for the purpose of prevention of sewage flow into the respiratory tract
Region
Japan

Condition
Condition patients with mechanical ventilation
Classification by specialty
Emergency medicine Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The main purpose of this study is to clarify the effectiveness of the mouse care method with the moisturizing gel for the patients with mechanical ventilation.
We also examine handiness, reproducibility and the cost-effectiveness.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The number of times of the intratracheal absorption.
Key secondary outcomes Bacterial count.

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking YES
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Maneuver
Interventions/Control_1 The group which applies the mouth care with flushing in after having applied the mouth care without flushing.
Interventions/Control_2 The group which applies the mouth care without flushing in after having applied the mouth care with flushing.
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

Not applicable
Gender Male and Female
Key inclusion criteria 1)Patients hospitalized to Kyoto medical center.
2)Patients on the ventilator for more than 48 hours.
3)Past history, drug history, age, gender and oral environment are no object.
Key exclusion criteria 1)The cases we can not get consent for the study by patients or their family.
2)Patients with evidence of VAP.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shizuko Fukuhara
Organization National Hospital Organization, Kyoto Medical Center
Division name oral and maxillofacial surgery
Zip code
Address 1-1 Mukaihata-cho, Fukakusa, Fushimi-ku,Kyoto-shi,Kyoto
TEL 075-641-9161
Email sfukuhar@kyotolan.hosp.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shizuko Fukuhara
Organization National Hospital Organization, Kyoto Medical Center
Division name oral and maxillofacial surgery
Zip code
Address 1-1 Mukaihata-cho, Fukakusa, Fushimi-ku,Kyoto-shi,Kyoto
TEL 075-641-9161
Homepage URL
Email sfukuhar@kyotolan.hosp.go.jp

Sponsor
Institute National Hospital Organization, Kyoto Medical Center
Institute
Department

Funding Source
Organization None
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
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
2014 Year 07 Month 29 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 Enrolling by invitation
Date of protocol fixation
2014 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 07 Month 29 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
2014 Year 07 Month 28 Day
Last modified on
2014 Year 09 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017023

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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