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Trial registered on ANZCTR
Registration number
ACTRN12620000528954
Ethics application status
Approved
Date submitted
30/03/2020
Date registered
30/04/2020
Date last updated
30/04/2020
Date data sharing statement initially provided
30/04/2020
Type of registration
Prospectively registered
Titles & IDs
Public title
Efficacy and safety of high frequency chest wall oscillation in paediatric patients with neuromuscular disorders
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Scientific title
Efficacy and safety of high frequency chest wall oscillation in paediatric patients with neuromuscular disorders
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Secondary ID [1]
300889
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Neuromuscular disease
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Impaired airway clearance
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Condition category
Condition code
Respiratory
315029
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0
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Other respiratory disorders / diseases
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Neurological
315030
315030
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0
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Neurodegenerative diseases
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Musculoskeletal
315252
315252
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0
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
High frequency chest wall oscillation (HFCWO) is an airway clearance technique recommended for respiratory management of neuromuscular conditions. This technique applies oscillations to the chest via a vest or wrap using an air pulse generator at a frequency of up to 20 compressions per second. These oscillations are thought to generate shearing forces and bias expiratory flow in the airways, facilitating secretion clearance. Participants will receive HFCWO regardless of their involvement in this study. Observational measurements will be taken for the duration of each physiotherapy intervention and repeated daily until discharge from PICU.
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Intervention code [1]
317212
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Not applicable
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Comparator / control treatment
Standard physiotherapy treatment consisting of a combination of positioning, percussion, expiratory vibration, manually assisted cough, mechanically assisted cough and airway suctioning. These modalities may be used individually or together with the aim of optimising airway clearance. Participants will receive standard physiotherapy treatment regardless of their involvement in this study. Observational measurements will be taken for the duration of each physiotherapy intervention and repeated daily until discharge from PICU.
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Control group
Active
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Outcomes
Primary outcome [1]
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Change in End expiratory lung volume as measured using electrical impedance tomography
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Assessment method [1]
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Timepoint [1]
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Immediately pre and post-intervention
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Primary outcome [2]
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Change in Global inhomogeneity index measured using electrical impedance tomography
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Assessment method [2]
323330
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Timepoint [2]
323330
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Immediately pre and post-intervention
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Primary outcome [3]
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Change in geometric centre measured using electrical impedance tomography
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Assessment method [3]
323331
0
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Timepoint [3]
323331
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Immediately pre and post intervention
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Secondary outcome [1]
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Change in lung aeration score measured using lung ultrasound
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Assessment method [1]
381593
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Timepoint [1]
381593
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Immediately pre and post intervention
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Secondary outcome [2]
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Change in P/F ratio using bedside monitoring
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Assessment method [2]
381594
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Timepoint [2]
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Immediately pre and post intervention
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Eligibility
Key inclusion criteria
Children aged up to 18 admitted to QCH PICU with the following:
• Diagnosed neuromuscular disorder
• Requiring chest physiotherapy for airway clearance
• Using non-invasive ventilation, either for respiratory support, sleep, or with airway clearance and requiring an escalation of pressures during chest physiotherapy
• In the acute phase of a respiratory exacerbation requiring intensive care admission
• Parent or guardian able and willing to provide informed consent
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Minimum age
1
Months
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Maximum age
18
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
• Children with unclear or unconfirmed neuromuscular diagnosis
• Children not requiring physiotherapy for airway clearance
• Children contraindicated for non-invasive ventilation including significant and undrained pneumothorax, chest trauma, facial trauma or facial burns, severe cardiovascular compromise
• Children contraindicated for treatment with HFCWO including open abdominal wounds, unstable spinal injuries, rib fractures, severe haemodynamic instability
• Skin conditions which would preclude the use of electrodes as used in EIT or ECG monitoring, or application of gel for ultrasound imaging
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Study design
Purpose
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Duration
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Selection
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Timing
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
4/05/2020
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Actual
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Date of last participant enrolment
Anticipated
3/05/2021
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Actual
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Date of last data collection
Anticipated
3/05/2021
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Actual
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Sample size
Target
7
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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Queensland Children's Hospital - South Brisbane
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Recruitment postcode(s) [1]
29712
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4101 - South Brisbane
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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Queensland Children's Hospital
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Address [1]
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501 Stanley St
South Brisbane
Queensland
4101
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Country [1]
305340
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Australia
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Primary sponsor type
Hospital
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Name
Queensland Children's Hospital
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Address
501 Stanley St
South Brisbane
Queensland
4101
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Country
Australia
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Secondary sponsor category [1]
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University
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Name [1]
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University of Queensland
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Address [1]
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Centre for Children's Health Research
62 Graham St, South Brisbane QLD 4101
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Country [1]
305707
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Children's Health Queensland
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Ethics committee address [1]
305673
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Centre for Children's Health Research
62 Graham St, South Brisbane QLD 4101
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Ethics committee country [1]
305673
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Australia
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Date submitted for ethics approval [1]
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21/11/2019
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Approval date [1]
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28/11/2019
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Ethics approval number [1]
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HREC/2019/QCHQ/57427 (Nov ver 2)
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Summary
Brief summary
Patients with neuromuscular disease can have impaired airway clearance which may lead to respiratory deterioration and death. Physiotherapy is vital in assisting with airway clearance for this patient population. Recent studies have suggested the use of high-frequency chest wall oscillation (HFCWO), however, there is little physiological evidence to support its efficacy. This study will use electrical impedance tomography and lung ultrasound to assess pre and post-treatment lung volume changes for patients receiving standard chest physiotherapy and HFCWO.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Mr Cameron Greenland
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Address
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Physiotherapy Department
Queensland Children's Hospital
501 Stanley St
South Brisbane
Queensland
4101
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Country
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Australia
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Phone
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+61 433286180
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Dr Judith Hough
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Address
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Paediatric Critical Care Research Group
Level 7
Centre for Children's Health Research
62 Graham St, South Brisbane QLD 4101
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Country
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Australia
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Phone
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+61 422404369
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Judith Hough
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Address
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Paediatric Critical Care Research Group
Level 7
Centre for Children's Health Research
62 Graham St, South Brisbane QLD 4101
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Country
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Australia
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Phone
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+61 422404369
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Fax
101180
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Children under 18 years of age and ethics does not permit.
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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.
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