UMIN-CTR Clinical Trial

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
Email	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
Email	awahiro73@med.kobe-u.ac.jp

Sponsor
Institute	Kobe University
Institute
Department

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
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 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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032143