UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study on the effects of oral care on the prevention of fever and pneumonia in tube-fed patients.
Title of the study (Brief title)	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	Kaoru Matsusaka
Organization	National Hospital Organization Hachinohe National Hospital
Division name	Nursing section
Address	3-13-1 Fukiage, Hachinohe City, Aomori Prefercture, 031-0003, Japan
TEL	0178-45-6111
Email	107sy01@hosp.go.jp

Public contact
Name of contact person	Mutsuo Yamaya
Organization	Tohoku University Graduate School of Medicine
Division name	Department of Advanced Preventive Medicine for Infectious Disease
Address	2-1 Seiryo-machi, Aoba-ku, Sendai, 980-8575 Japan
TEL	022-717-7184
Homepage URL
Email	myamaya@med.tohoku.ac.jp

Sponsor
Institute	National Hospital Organization Hachinohe National Hospital
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 12 Month 07 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://onlinelibrary.wiley.com/journal/14470594
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).
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023220