Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000627954
Ethics application status
Approved
Date submitted
11/06/2011
Date registered
21/06/2011
Date last updated
21/06/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Can regular use of the Cough Assist machine maintain lung function in children and adolescents with neuromuscular disease?
Scientific title
Can regular use of the Cough Assist machine maintain lung function in children and adolescents with neuromuscular disease?
Secondary ID [1] 262363 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
neuromuscular disease with diminished lung function 268067 0
Condition category
Condition code
Respiratory 268212 268212 0 0
Other respiratory disorders / diseases
Musculoskeletal 268244 268244 0 0
Other muscular and skeletal disorders
Neurological 268245 268245 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
using the Cough Assist machine every day and night (ie twice daily) taking 3-5 breaths, then coughing and repeating 3-5 cycles. For each breath there should be a 2 second inspiration and a 3 second expiration, with a 30 second rest between breaths. Pressure used fell between 30-40cm H2O but was left up to individual patient comfort, for a period of four months. The machine is used via a face mask or mouth piece connecting the mask via a tube to the actual machine
Intervention code [1] 266757 0
Treatment: Devices
Comparator / control treatment
nil treatment added
Control group
Active

Outcomes
Primary outcome [1] 268949 0
using the Vitalograph Alpha 6000 spirometer to measure vital capacity (L), peak expiratory flow (L/min) and peak cough flow (L/min) of all participants. This will give an indication of whether lung function is being maintained.
Timepoint [1] 268949 0
these meaures will be taken monthly over a four month period (March 2011 - June 2011)
Secondary outcome [1] 276673 0
nil
Timepoint [1] 276673 0
nil

Eligibility
Key inclusion criteria
neuromuscular disease, under 18 yrs of age, able to provide consent, English speaking,
Minimum age
10 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
ambulant, unable to provide appropriate spirometry measures

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
7/03/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
8
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 267238 0
Self funded/Unfunded
Name [1] 267238 0
Laura Gotti
Country [1] 267238 0
Australia
Primary sponsor type
University
Name
University of Notre Dame Australia
Address
19 Mouat Street, (PO Box 1225), Fremantle, WA 6959
Country
Australia
Secondary sponsor category [1] 266303 0
None
Name [1] 266303 0
nil
Address [1] 266303 0
nil
Country [1] 266303 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
the main hypothesis of this study is to prove whether using the cough assist regularly twice a day will help maintain lung function in children with neuromuscular disease
Trial website
nil
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32734 0
Address 32734 0
Country 32734 0
Phone 32734 0
Fax 32734 0
Email 32734 0
Contact person for public queries
Name 15981 0
Laura Gotti, 4th year physiotherapy student
Address 15981 0
19 Mouat Street, (PO Box 1225), Fremantle, WA 6959
Country 15981 0
Australia
Phone 15981 0
(61 8) 9433 0555 / FREECALL: 1800 640 500/
Fax 15981 0
Email 15981 0
[email protected]
Contact person for scientific queries
Name 6909 0
Laura Gotti, 4th year physiotherapy student
Address 6909 0
19 Mouat Street, (PO Box 1225), Fremantle, WA 6959
Country 6909 0
Australia
Phone 6909 0
(61 8) 9433 0555 / FREECALL: 1800 640 500/
Fax 6909 0
Email 6909 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.