UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006569 |
|---|---|
| Receipt number | 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 09:19:19 |
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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
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
t_kaneko@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007778
