UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039492 |
|---|---|
| Receipt number | R000045031 |
| Scientific Title | Assessment protocol for swallowing function after aspiration pneumonia: Retrospective cohort study |
| Date of disclosure of the study information | 2020/02/15 |
| Last modified on | 2020/02/15 14:31:41 |
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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
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
a5mb1037thk@gmail.com
Sponsor or person
Institute
Akashi Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045031
