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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018195
Receipt No. 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

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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 Obsterics 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
Email 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
Email sakiko-kataoka@kuh.kumamoto-u.ac.jp

Sponsor
Institute Department of Nursing, Kumamoto University Hospital
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020990

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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