UMIN-CTR Clinical Trial

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

dysphagia

Classification by specialty

Geriatrics

Nursing

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Interventional

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

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

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

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

Email

hsanada-tky@umin.ac.jp

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

Email

yukam-tky@umin.ac.jp

Institute

The University of Tokyo, Graduate School of Medicine

Institute

Department

Personal name

Organization

Japan Society for the Promotion of Science

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan

Co-sponsor

Gerodontology, Department of Gerodontology,
Division of Gerontology and Gerodontology,
GraduateSchool, Tokyo Medical and Dental University

Name of secondary funder(s)

No

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

特別養護老人ホームアトリエ村（東京都）

Date of disclosure of the study information

2014

Year

12

Month

19

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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