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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000025359
Receipt No. R000029133
Scientific Title The effect of mechanically In-Exsufflator (MIE: Cough assist E70) for patients with pneumonia or bronchitis
Date of disclosure of the study information 2017/01/01
Last modified on 2019/08/30

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Basic information
Public title The effect of mechanically In-Exsufflator (MIE: Cough assist E70) for patients with pneumonia or bronchitis
Acronym The effect of mechanically In-Exsufflator
Scientific Title The effect of mechanically In-Exsufflator (MIE: Cough assist E70) for patients with pneumonia or bronchitis
Scientific Title:Acronym The effect of mechanically In-Exsufflator
Region
Japan

Condition
Condition Pneumonia or bronchitis
Classification by specialty
Medicine in general Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of mechanically In-Exsufflator for inpatients with pneumonia or bronchitis
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Availability of self-expectration volume of sputum by bronchus aspiration
Key secondary outcomes SpO2, peak inspiratory pressure (PIP), tidal volume (TV),CPF, rattling, breath sound

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 MIE use
Interventions/Control_2 6 deep breaths
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria *CPF:<=270
*Patients are adaptable to MIE judged by doctor
*Patients are able to cough or huff on one's own under therapist's orders
Key exclusion criteria *Patients with a history of pneumothorax, mediastinal emphysema, emphysema with severe bulla
*Patients with pulmonary disorder by ventilator, arrhythmia, heart failure
*Patients feel poorly or discomfort using MIE, or refuse to use MIE
Target sample size 14

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shoutarou Ishimori
Organization Tibatokushuukai hospital of okinawatokushuukai medical Corporation
Division name Respiratory medicine department
Zip code
Address 2-11-1 Takasudai Funabashi,Chiba Prefecture,Japan 274-0065
TEL 047-466-7111
Email rehabili@chibatoku.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shoutarou Ishimori
Organization Tibatokushuukai hospital of okinawatokushuukai medical Corporation
Division name Respiratory medicine department
Zip code
Address 2-11-1 Takasudai Funabashi,Chiba Prefecture,Japan 274-0065
TEL 047-466-7111
Homepage URL
Email rehabili@chibatoku.or.jp

Sponsor
Institute Tibatokushuukai hospital of okinawatokushuukai medical Corporation
Institute
Department

Funding Source
Organization Tibatokushuukai hospital of okinawatokushuukai medical Corporation
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

Other administrative information
Date of disclosure of the study information
2017 Year 01 Month 01 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 Terminated
Date of protocol fixation
2016 Year 02 Month 05 Day
Date of IRB
2016 Year 02 Month 26 Day
Anticipated trial start date
2016 Year 02 Month 26 Day
Last follow-up date
2018 Year 08 Month 06 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 12 Month 21 Day
Last modified on
2019 Year 08 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029133

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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