UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Predictive factors for achieving oral intake in elderly patients with aspiration pneumonia: videofluoroscopic evaluation of swallowing function.
Title of the study (Brief title)	Predictive factors for achieving oral intake in elderly patients with aspiration pneumonia
Region	Japan

Condition
Condition	Aspiration Pneumonia
Classification by specialty	Geriatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	to examine the predictive factors, including videofluoroscopic swallowing evaluation, for achieving oral intake in elderly patients with aspiration pneumonia.
Basic objectives2	Others
Basic objectives -Others	exmine the predictive factors
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Acheivement of oral intake after 4 weeks from performing Videofluoroscopic evaluation of swallowing function
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	65 years-old <=
Age-upper limit	100 years-old >=
Gender	Male and Female
Key inclusion criteria	Study participants were selected from among 246 consecutive patients who were aged over than 65 years hospitalized at Kawasaki municipal hospital from April 2012 through March 2014 due to aspiration pneumonia.
Key exclusion criteria	patients with alternative nutrition patients who died during their hospital stay patients who started to oral nutrition just after admission without evaluating detailed swallowing function patients who didnt start oral intake by using bedside screening test
Target sample size	150

Research contact person
Name of lead principal investigator	Mari Ito
Organization	Keio University School of Medicine
Division name	Department of Rehabilitation Medicine
Address	35 Shinanomachi Shinjuku ku Tokyo
TEL	0353633833
Email	marippe419@yahoo.co.jp

Public contact
Name of contact person	Mari Ito
Organization	Kawasaki municipal hospital
Division name	Department of Rehabilitation
Address	12-1 Shinkawa tori Kawasaki ku Kawasaki city
TEL	0442335521
Homepage URL
Email	marippe419@yahoo.co.jp

Sponsor
Institute	Kawasaki Municipal Hospital
Institute
Department

Funding Source
Organization	Kawasaki Municipal 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

Other administrative information
Date of disclosure of the study information	2017 Year 11 Month 13 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 08 Month 10 Day
Anticipated trial start date	2016 Year 08 Month 10 Day
Last follow-up date	2016 Year 08 Month 10 Day
Date of closure to data entry	2017 Year 11 Month 10 Day
Date trial data considered complete	2017 Year 11 Month 13 Day
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Factors likely related with oral intake including swallowing, nutritional, metabolic and functional status, pneumonia severity and comorbidities were extracted from the medical record. Multiple logistic regression analysis was performed to identify independent predictive factors for acquisition of oral intake.

Management information
Registered date	2017 Year 11 Month 13 Day
Last modified on	2017 Year 11 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034204