UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029330
Receipt number R000033524
Scientific Title Examination of the instruction method of manual breathing assist technique using the visual feedback
Date of disclosure of the study information 2017/09/28
Last modified on 2019/09/30 14:36:48

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Basic information

Public title

Examination of the instruction method of manual breathing assist technique using the visual feedback

Acronym

Examination of the instruction method of manual breathing assist technique using the visual feedback

Scientific Title

Examination of the instruction method of manual breathing assist technique using the visual feedback

Scientific Title:Acronym

Examination of the instruction method of manual breathing assist technique using the visual feedback

Region

Japan


Condition

Condition

Healthy adult

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

An investigation of the instruction effect of the manual breathing assist technique using the visual feedback

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

pressure of volar aspect
tidal volume

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

4

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Maneuver

Interventions/Control_1

manual breathing assist while looking change of volar aspect pressure
10 times

Interventions/Control_2

manual breathing assist while looking change of tidal volume
10 times

Interventions/Control_3

manual breathing assist while looking change of volar aspect pressure and tidal volume
10 times

Interventions/Control_4

normal manual breathing assist
10 times

Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

60 years-old >

Gender

Male and Female

Key inclusion criteria

Healthy adult

Key exclusion criteria

Medical illness
Motility disorder
Person with the clinical experience of the manual breathing assist

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Mamiko
Middle name
Last name Kamoshida

Organization

Hokkaido University of Science

Division name

Department of Physical Therapy

Zip code

006-8585

Address

7-15-4-1 Maeda, Teine, Sapporo, Hokkaido, JAPAN

TEL

0116887194

Email

kamoshida-m@hus.ac.jp


Public contact

Name of contact person

1st name Mamiko
Middle name
Last name Kamoshida

Organization

Hokkaido University of Science

Division name

Department of Physical Therapy

Zip code

006-8585

Address

7-15-4-1 Maeda, Teine, Sapporo, Hokkaido, JAPAN

TEL

011-688-7194

Homepage URL


Email

kamoshida-m@hus.ac.jp


Sponsor or person

Institute

Hokkaido University of Science

Institute

Department

Personal name



Funding Source

Organization

Hokkaido University of Science

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

Hokkaido University of Science

Address

7-15-4-1 Maeda, Teine, Sapporo, Hokkaido, JAPAN

Tel

0116882161

Email

kamoshida-m@hus.ac.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

2017 Year 09 Month 28 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

52

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 08 Month 01 Day

Date of IRB

2017 Year 09 Month 19 Day

Anticipated trial start date

2017 Year 10 Month 10 Day

Last follow-up date

2019 Year 10 Month 10 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 09 Month 28 Day

Last modified on

2019 Year 09 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033524


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name