Trial Review

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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
Scientific title
Efficacy and safety of high frequency chest wall oscillation in paediatric patients with neuromuscular disorders
Secondary ID [1] 300889 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neuromuscular disease 316821 0
Impaired airway clearance 316822 0
Condition category
Condition code
Respiratory 315029 315029 0 0
Other respiratory disorders / diseases
Neurological 315030 315030 0 0
Neurodegenerative diseases
Musculoskeletal 315252 315252 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 317212 0
Not applicable
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.
Control group
Active

Outcomes
Primary outcome [1] 323329 0
Change in End expiratory lung volume as measured using electrical impedance tomography
Timepoint [1] 323329 0
Immediately pre and post-intervention
Primary outcome [2] 323330 0
Change in Global inhomogeneity index measured using electrical impedance tomography
Timepoint [2] 323330 0
Immediately pre and post-intervention
Primary outcome [3] 323331 0
Change in geometric centre measured using electrical impedance tomography
Timepoint [3] 323331 0
Immediately pre and post intervention
Secondary outcome [1] 381593 0
Change in lung aeration score measured using lung ultrasound
Timepoint [1] 381593 0
Immediately pre and post intervention
Secondary outcome [2] 381594 0
Change in P/F ratio using bedside monitoring
Timepoint [2] 381594 0
Immediately pre and post intervention

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
Minimum age
1 Months
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/05/2020
Actual
Date of last participant enrolment
Anticipated
3/05/2021
Actual
Date of last data collection
Anticipated
3/05/2021
Actual
Sample size
Target
7
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 16171 0
Queensland Children's Hospital - South Brisbane
Recruitment postcode(s) [1] 29712 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 305340 0
University
Name [1] 305340 0
Queensland Children's Hospital
Country [1] 305340 0
Australia
Primary sponsor type
Hospital
Name
Queensland Children's Hospital
Address
501 Stanley St
South Brisbane
Queensland
4101
Country
Australia
Secondary sponsor category [1] 305707 0
University
Name [1] 305707 0
University of Queensland
Address [1] 305707 0
Centre for Children's Health Research
62 Graham St, South Brisbane QLD 4101
Country [1] 305707 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305673 0
Children's Health Queensland
Ethics committee address [1] 305673 0
Centre for Children's Health Research
62 Graham St, South Brisbane QLD 4101
Ethics committee country [1] 305673 0
Australia
Date submitted for ethics approval [1] 305673 0
21/11/2019
Approval date [1] 305673 0
28/11/2019
Ethics approval number [1] 305673 0
HREC/2019/QCHQ/57427 (Nov ver 2)

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 101178 0
Mr Cameron Greenland
Address 101178 0
Physiotherapy Department
Queensland Children's Hospital
501 Stanley St
South Brisbane
Queensland
4101
Country 101178 0
Australia
Phone 101178 0
+61 433286180
Fax 101178 0
Email 101178 0
cameron.greenland2@health.qld.gov.au
Contact person for public queries
Name 101179 0
Dr Judith Hough
Address 101179 0
Paediatric Critical Care Research Group
Level 7
Centre for Children's Health Research
62 Graham St, South Brisbane QLD 4101
Country 101179 0
Australia
Phone 101179 0
+61 422404369
Fax 101179 0
Email 101179 0
j.hough@uq.edu.au
Contact person for scientific queries
Name 101180 0
Dr Judith Hough
Address 101180 0
Paediatric Critical Care Research Group
Level 7
Centre for Children's Health Research
62 Graham St, South Brisbane QLD 4101
Country 101180 0
Australia
Phone 101180 0
+61 422404369
Fax 101180 0
Email 101180 0
j.hough@uq.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Children under 18 years of age and ethics does not permit.


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.