UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025359 |
|---|---|
| Receipt number | 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 13:46:22 |
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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
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
rehabili@chibatoku.or.jp
Sponsor or person
Institute
Tibatokushuukai hospital of okinawatokushuukai medical Corporation
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029133
