UMIN-CTR Clinical Trial

Basic information
Public title	Assessment protocol for swallowing function after aspiration pneumonia: Retrospective cohort study
Acronym	Assessment protocol for swallowing function after aspiration pneumonia: Retrospective cohort study
Scientific Title	Assessment protocol for swallowing function after aspiration pneumonia: Retrospective cohort study
Scientific Title:Acronym	Assessment protocol for swallowing function after aspiration pneumonia: Retrospective cohort study
Region	Japan

Condition
Condition	aspiration pneumonia
Classification by specialty	Medicine in general Geriatrics Rehabilitation medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Our assessment protocol for swallowing function refers to Japanese practical guidelines for dysphagia. We evaluate the protocol and whether it could be used as a basis for decision on safe and timely restart of adequate food intake for patients with aspiration pneumonia.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	days until oral intake
Key secondary outcomes	aspiration and/or choking the amount of nutritional intake duration of hospitalization decline in swallowing ability(assessed by differences between premorbid FOIS scores before onset and at the end of treatment)

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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Diagnosis of aspiration pneumonia was made according to the following criteria: 1) Presence of a new gravity-dependent infiltrate on a chest radiography or computed tomography image. 2) Presence of two or more of the following: leukocytosis, fever, purulent sputum, or high C-reactive protein (CRP) level. 3) Positive for a simple dysphagia screening, which included a water swallowing or food test administered by nurses.
Key exclusion criteria	Those unable to eat due to severe dysphagia according to assessment by an expert nurse, patients dependent on artificial nutrition (gastrostomy or total parenteral nutrition), and patients who died during hospitalization.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Yohei Middle name Last name Kanzawa
Organization	Akashi Medical Center
Division name	Department of General Internal Medicine
Zip code	674-0063
Address	743-33 Yagi, Okubo-Cho, Akashi, Hyogo
TEL	078-936-1101
Email	a5mb1037thk@gmail.com

Public contact
Name of contact person	1st name Yohei Middle name Last name Kanzawa
Organization	Akashi Medical Center
Division name	Department of General Internal Medicine
Zip code	674-0063
Address	743-33 Yagi, Okubo-Cho, Akashi, Hyogo
TEL	078-936-1101
Homepage URL
Email	a5mb1037thk@gmail.com

Sponsor
Institute	Akashi Medical Center
Institute
Department

Funding Source
Organization	none
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	Akashi Medical Center
Address	743-33 Yagi, Okubo-Cho, Akashi, Hyogo
Tel	078-936-1101
Email	kawata@amc1.jp

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	2020 Year 02 Month 15 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	101
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	2017 Year 06 Month 08 Day
Date of IRB	2017 Year 06 Month 08 Day
Anticipated trial start date	2017 Year 06 Month 08 Day
Last follow-up date	2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	We conducted a retrospective cohort study of adult patients with aspiration pneumonia admitted to Department of General Internal Medicine, Akashi Medical Center. We recorded outcome and patient information by chart review.

Management information
Registered date	2020 Year 02 Month 15 Day
Last modified on	2020 Year 02 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045031