UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016002 |
|---|---|
| Receipt number | R000018600 |
| Scientific Title | A randomized controlled trial on the effects of the prevention of aspiration pneumonia by an ultrasound method to detect aspiration |
| Date of disclosure of the study information | 2014/12/19 |
| Last modified on | 2014/12/22 20:55:33 |
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Basic information
Public title
A randomized controlled trial on the effects of the prevention of aspiration pneumonia by an ultrasound method to detect aspiration
Acronym
A randomized controlled trial on the effects of the prevention of aspiration pneumonia by an ultrasound method to detect aspiration
Scientific Title
A randomized controlled trial on the effects of the prevention of aspiration pneumonia by an ultrasound method to detect aspiration
Scientific Title:Acronym
A randomized controlled trial on the effects of the prevention of aspiration pneumonia by an ultrasound method to detect aspiration
Region
| Japan |
Condition
Condition
dysphagia
Classification by specialty
| Geriatrics | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the effect of a detection method for aspiration by ultrasonography in older adult residents in a nursing home. The effect is a reduction of the risk of aspiration pneumonia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The proportion of the residents with reduced frequency of aspiration which was detected by ultrasonography at eight weeks after the intervention.
Key secondary outcomes
Comparison between intervention group and control group at eight week point;
1. Incidence of aspiration pneumonia (Aspiration pneumonia is defined as 1) a condition in which fever more than 37.5C accompanied by the symptoms of the upper respiratory tract infection, or 2) a condition diagnosed as aspiration pneumonia by physicians)
2. Incidence of change in the swallowing care (modification of the type of the food, use of the thickener and practice of alternative swallowing) and the operation of the videoendoscopic examination for swallowing.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver | Other |
Interventions/Control_1
Control group: the residents receive the standard swallowing care based on the conventional observation and tests during eight weeks.
Interventions/Control_2
1. Individuals without oral food intake on a daily basis.
2. Individuals whose physicians or care staffs have determined that they are not eligible for ultrasound examination due to tracheostomy or laryngectomy.
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Residents in a nursing home with oral intake of food.
Key exclusion criteria
1. Individuals without oral food intake on a daily basis.
2. Individuals whose physicians or care staffs have determined that they are not eligible for ultrasound examination due to tracheostomy or laryngectomy.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiromi Sanada |
Organization
The University of Tokyo, Graduate School of Medicine
Division name
Division of Health Science and Nursing, Department of Gerontological Nursing and Wound Care Management
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033, JAPAN
TEL
03-5841-3419
hsanada-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuka Miura |
Organization
The University of Tokyo, Graduate School of Medicine
Division name
Division of Health Science and Nursing, Department of Gerontological Nursing and Wound Care Manageme
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033, JAPAN
TEL
03-5841-3439
Homepage URL
yukam-tky@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo, Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Gerodontology, Department of Gerodontology,
Division of Gerontology and Gerodontology,
GraduateSchool, Tokyo Medical and Dental University
Name of secondary funder(s)
No
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
特別養護老人ホームアトリエ村（東京都）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 12 | Month | 19 | 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
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
Enrolling by invitation
Date of protocol fixation
| 2014 | Year | 12 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 12 | Month | 20 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 12 | Month | 19 | Day |
Last modified on
| 2014 | Year | 12 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018600
