UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018195 |
|---|---|
| Receipt number | R000020990 |
| Scientific Title | Study of oral management for patients with intubation in ICU |
| Date of disclosure of the study information | 2015/07/15 |
| Last modified on | 2017/05/19 11:02:23 |
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Basic information
Public title
Study of oral management for patients with intubation in ICU
Acronym
Study of oral management for patients with intubation in ICU
Scientific Title
Study of oral management for patients with intubation in ICU
Scientific Title:Acronym
Study of oral management for patients with intubation in ICU
Region
| Japan |
Condition
Condition
All patients admitted in ICU (except patients under 15 years old)
Classification by specialty
| Medicine in general | Gastroenterology | Hepato-biliary-pancreatic medicine |
| Cardiology | Pneumology | Endocrinology and Metabolism |
| Hematology and clinical oncology | Nephrology | Neurology |
| Clinical immunology | Psychosomatic Internal Medicine | Infectious disease |
| Geriatrics | Surgery in general | Gastrointestinal surgery |
| Hepato-biliary-pancreatic surgery | Vascular surgery | Chest surgery |
| Endocrine surgery | Breast surgery | Obstetrics and Gynecology |
| Ophthalmology | Dermatology | Psychiatry |
| Oto-rhino-laryngology | Orthopedics | Urology |
| Radiology | Oral surgery | Neurosurgery |
| Cardiovascular surgery | Plastic surgery | Emergency medicine |
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study the effect of oral care protocol on the onset ratio of ventilator-assosiated -pneumonia (VAP) and the oral environmental changes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Onset ratio of VAP and oral environment changes (moisture, odor.fur and bacterial numbers)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom | Maneuver |
Interventions/Control_1
Gruoup A: Use of oral humectant after oral brushing and rinse with water three times a day.
The deta were collected during the period of intubation.
Interventions/Control_2
Group B: Use of oral humectant after oral brushing and rinse with water twice a day. Use of oral bacterial plaque stain for teeth before mouth brushing and rinse once a day. The deta were collected during the period of intubation.
Interventions/Control_3
Group C: Use of oral humectant each 2 hours after oral brushing and rinse with water three times a day.The deta were collected during the period of intubation.
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
Patients who needed intubation over 3 days in ICU.
Key exclusion criteria
Patients who are under 15 years old or drawing near death.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sakiko Kataoka |
Organization
Kumamoto University Hospital
Division name
Intensive Care Unit
Zip code
Address
1-1-1 Honjo, Chuou- ku, Kumamoto city
TEL
096-373-7031
sakiko-kataoka@kuh.kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sakiko Kataoka |
Organization
Kumamoto University Hospital
Division name
Intensive Care Unit
Zip code
Address
1-1-1 Honjo, Chuou- ku, Kumamoto city
TEL
096-373-7031
Homepage URL
sakiko-kataoka@kuh.kumamoto-u.ac.jp
Sponsor or person
Institute
Department of Nursing, Kumamoto University Hospital
Institute
Department
Personal name
Funding Source
Organization
Kumamoto University Hospital
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
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
| 2015 | Year | 07 | Month | 15 | 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
| 2015 | Year | 07 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | Month | 15 | Day |
Last follow-up date
| 2016 | Year | 10 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2017 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 07 | Month | 05 | Day |
Last modified on
| 2017 | Year | 05 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020990
