UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020099 |
|---|---|
| Receipt number | R000023220 |
| Scientific Title | Study on the effects of oral care on the prevention of fever and pneumonia in tube-fed patients. |
| Date of disclosure of the study information | 2015/12/07 |
| Last modified on | 2018/06/09 12:17:55 |
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Basic information
Public title
Study on the effects of oral care on the prevention of fever and pneumonia in tube-fed patients.
Acronym
Study on the effects of oral care on the prevention of fever and pneumonia in tube-fed patients.
Scientific Title
Study on the effects of oral care on the prevention of fever and pneumonia in tube-fed patients.
Scientific Title:Acronym
Study on the effects of oral care on the prevention of fever and pneumonia in tube-fed patients.
Region
| Japan |
Condition
Condition
Tube-fed patients
Classification by specialty
| Pneumology | Geriatrics | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study the effects of oral care to prevent fever and pneumonia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Frequency of fever,
Frequency of pneumonia and the time to the first pneumonia
Key secondary outcomes
Serum protein concentration, number of lymphocytes in the peripheral venous blood at the admission to the hospital
Cause of death
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Perform oral care
Frequency: Brushing palate, mandibular mucosa and tongue dorsum with a toothbrush, once daily
Period: During the admission to the Hachinohe Hospital
Interventions/Control_2
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Tube-fed and bedridden patients
Key exclusion criteria
Patients judged inappropriate by physicians
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kaoru Matsusaka |
Organization
National Hospital Organization Hachinohe National Hospital
Division name
Nursing section
Zip code
Address
3-13-1 Fukiage, Hachinohe City, Aomori Prefercture, 031-0003, Japan
TEL
0178-45-6111
107sy01@hosp.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mutsuo Yamaya |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Advanced Preventive Medicine for Infectious Disease
Zip code
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, 980-8575 Japan
TEL
022-717-7184
Homepage URL
myamaya@med.tohoku.ac.jp
Sponsor or person
Institute
National Hospital Organization Hachinohe National Hospital
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization Hachinohe National Hospital
Organization
Division
Category of Funding Organization
Self funding
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
独立行政法人国立病院機構八戸病院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 12 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/journal/14470594
Number of participants that the trial has enrolled
Results
The levels of serum total protein and albumin in patients with pneumonia were lower than the levels in patients without pneumonia. In the multivariate analysis, low levels of albumin and urine bacteria were independently associated with pneumonia. We developed a bedridden patient pneumonia risk (BPPR) score using these two risk factors to assess pneumonia risk. The proportion of pneumonia patients increased with increasing BPPR score when the patients were divided into three groups, low, moderate and high risk, according to the BPPR score (0, 1 or 2, respectively).
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 | 12 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 12 | Month | 07 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 12 | Month | 07 | Day |
Last modified on
| 2018 | Year | 06 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023220
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
