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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006569
Receipt No. R000007778
Scientific Title A comparison of two oral-care protocols using the plaque control record.
Date of disclosure of the study information 2011/10/18
Last modified on 2014/05/13

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Basic information
Public title A comparison of two oral-care protocols using the plaque control record.
Acronym A comparison of two oral-care protocols using the plaque control record.
Scientific Title A comparison of two oral-care protocols using the plaque control record.
Scientific Title:Acronym A comparison of two oral-care protocols using the plaque control record.
Region
Japan

Condition
Condition Post elective cardiovascular or esophagus surgery patients with teeth under tracheal intubation.
Classification by specialty
Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Compare the effectiveness and safety of the careful oral-care protocol with conventional oral-care using plaque control record.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The oral hygiene state evaluated by the plaque control record.
Key secondary outcomes The morbidity of pneumonia and the mortality.

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 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Experimental arm
Period:From ICU admission just after the surgery to the second day of the surgery.
Method:Brush the teeth and clean up the intraoral mucous secretion with leaving the secured tape for the tube and the bite block alone three times a day.
1)On ICU admission
2)After the oral-care on the second day of the ICU.
3)Before the oral-care on the third day of the ICU.
Interventions/Control_2 Control arm
Method:Remove the fixed tape of the tracheal tube and provide the oral-care using a gag once a day on day time.
Only mucosal cleaning is provided at the night time, without removing of the fixed tape of the tracheal tube.
1)On ICU admission
2)After the oral-care on the second day of the ICU.
3)Before the oral-care on the third day of the ICU.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)The patients of post elective surgery of the cardiovascular system or esophagus.
2)The patients who admit ICU with oro-tracheal intubation.
3)Existence teeth people.
4)The patients who agreed and signed the consent.
Key exclusion criteria None

Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomoko Kaneko
Organization Yokohama City University Medical Center
Division name GICU
Zip code
Address 4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL 045-261-5656
Email t_kaneko@yokohama-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomoko Kaneko
Organization Yokohama City University Medical Center
Division name GICU
Zip code
Address 4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL 045-261-5656
Homepage URL
Email t_kaneko@yokohama-cu.ac.jp

Sponsor
Institute Yokohama City University Medical Center
Institute
Department

Funding Source
Organization Yokohama Foundation for Advancement of Medical Science.
Organization
Division
Category of Funding Organization Non profit foundation
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 横浜市立大学附属市民総合医療センター(神奈川県)

Other administrative information
Date of disclosure of the study information
2011 Year 10 Month 18 Day

Related information
URL releasing protocol
Publication of results Published

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
2011 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 10 Month 01 Day
Last follow-up date
2013 Year 12 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
2011 Year 10 Month 18 Day
Last modified on
2014 Year 05 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007778

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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