UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028080 |
|---|---|
| Receipt number | R000032143 |
| Scientific Title | The effectiveness and safeness of air oscillation function of Cough AssistTM for airway clearance in neuromuscular disease patient |
| Date of disclosure of the study information | 2017/10/01 |
| Last modified on | 2019/12/02 20:21:39 |
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Basic information
Public title
The effectiveness and safeness of air oscillation function of Cough AssistTM for airway clearance in neuromuscular disease patient
Acronym
The air oscillation function of Cough AssistTM
Scientific Title
The effectiveness and safeness of air oscillation function of Cough AssistTM for airway clearance in neuromuscular disease patient
Scientific Title:Acronym
The air oscillation function of Cough AssistTM
Region
| Japan |
Condition
Condition
Neuromuscular disease
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Exploratory test of Mechanical assisted coughing (MAC) with oscillation function for airway clearance in neuromuscular patient
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change value of SpO2 after MAC
Key secondary outcomes
Change value of heart rate after MAC
Incidence of adverse event
Incidence of complication
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Add oscillation function to Cough Assist E70 TM
Day by day for 7 days
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
| 0 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Hospitalized neuromuscular disease patients with airway infection
Patients who are using Cough Assist E70 or are going to use Cough Assist E70
Key exclusion criteria
Patients who require intubation
Patients who show low SpO2 (below 90 percent)
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Awano |
Organization
Kobe University Hospital
Division name
Department of Pediatrics
Zip code
Address
7-5-1, Kusucnoki-cho, Chuo-ku, Kobe, Japan
TEL
+81-78-382-6090
awahiro73@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Awano |
Organization
Kobe University Hospital
Division name
Department of Pediatrics
Zip code
Address
7-5-1, Kusucnoki-cho, Chuo-ku, Kobe, Japan
TEL
+81-78-382-6090
Homepage URL
awahiro73@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University
Institute
Department
Personal name
Funding Source
Organization
Department of Pediatrics, Kobe University Graduate School of Medicine
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
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 | 10 | Month | 01 | 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
Completed
Date of protocol fixation
| 2017 | Year | 07 | Month | 04 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 27 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
| 2019 | Year | 11 | Month | 30 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 07 | Month | 05 | Day |
Last modified on
| 2019 | Year | 12 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032143
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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