UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030519
Receipt number R000034843
Scientific Title Study about a breathing timing and the deglutition timing in the respirator wearing patients
Date of disclosure of the study information 2017/12/22
Last modified on 2017/12/22 13:20:43

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Basic information

Public title

Study about a breathing timing and the deglutition timing in the respirator wearing patients

Acronym

Study of the timing of breathing and the deglutition

Scientific Title

Study about a breathing timing and the deglutition timing in the respirator wearing patients

Scientific Title:Acronym

Study of the timing of breathing and the deglutition

Region

Japan


Condition

Condition

Myopathy
Neurologic disease

Classification by specialty

Neurology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Examine whether you are associated with the ventilatory pattern of the use of respirator patients in a deglutition timing.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Ventilation timing of the respirator.
Hearing of the deglutition sound.

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Being neurologic disease and myopathy.

Key exclusion criteria

pneumonia.
The patients who cannot do mutual understanding.
The patients who were judged to be inadequate.s who were judged to be inadequate.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tomotaka Ueda

Organization

Nishikyusyu University

Division name

Faculty of Rehabilitation Sciences

Zip code


Address

4490-9 Ozaki Kanzaki-city, Saga, JP

TEL

0952-52-4191

Email

tmtk0612-nisikyu@yahoo.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tomotaka Ueda

Organization

Nishikyusyu University

Division name

Faculty of Rehabilitation Sciences

Zip code


Address

4490-9 Ozaki Kanzaki-city, Saga, JP

TEL

0952-52-4191

Homepage URL


Email

tmtk0612-nisikyu@yahoo.co.jp


Sponsor or person

Institute

Nishikyusyu University

Institute

Department

Personal name



Funding Source

Organization

Nishikyusyu University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

長崎川棚医療センター(長崎県)仙台徳洲会病院(宮城県)


Other administrative information

Date of disclosure of the study information

2017 Year 12 Month 22 Day


Related information

URL releasing protocol


Publication of results

Partially published


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

2016 Year 03 Month 26 Day

Date of IRB


Anticipated trial start date

2016 Year 04 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Ventilation timing of the respirator.
Hearing of the deglutition sound.


Management information

Registered date

2017 Year 12 Month 22 Day

Last modified on

2017 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=R000034843


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name