Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001681145
Ethics application status
Approved
Date submitted
18/09/2019
Date registered
29/11/2019
Date last updated
19/07/2022
Date data sharing statement initially provided
29/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Does the MetaNeb®, a new airway clearance device, change lung function in adults
with cystic fibrosis when they are hospitalised for a lung infection?
Scientific title
Effect of the MetaNeb® on measures of lung clearance index, other measures of lung function and patient reported outcomes in individuals admitted to hospital for an acute exacerbation of their Cystic Fibrosis: a randomised controlled trial
Secondary ID [1] 299093 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cystic Fibrosis 314133 0
Condition category
Condition code
Human Genetics and Inherited Disorders 312508 312508 0 0
Cystic fibrosis
Respiratory 313654 313654 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The MetaNeb® System (Hill-Rom, Inc. Batesville, Indiana, USA) is a relatively new device that has been developed to facilitate airway clearance in individuals with acute and chronic
lung conditions, including CF. It was introduced for clinical use in Australia in 2016. The
MetaNeb® incorporates two modes; (i) continuous positive expiratory pressure (CPEP) and, (ii) continuous high frequency oscillation (CHFO). The CPEP mode assists with lung expansion and recruitment by delivering PEP, whereas the CHFO mode aids secretion clearance by providing pulsatile positive airway pressure at two different frequencies (similar to intrapulmonary percussive ventilation [IPV].)These modes deliver positive airway pressure and airway oscillation throughout both inspiration and expiration. The device also allows three varying levels of PEP to be applied at the mouthpiece, and a nebulised mucolytic (e.g. saline or hypertonic saline) to be delivered while the device is in use. Multiple interfaces can be used to deliver the therapy including a face mask, mouthpiece or tracheostomy. In this study we will be using the mouthpiece only.

Participants allocated to the experimental group will be asked to complete 30 minutes of supervised physiotherapy, twice daily, using the MetaNeb® system (Hill-Rom, Inc. Batesville, Indiana, USA) with their usual inhaled mucolytics (either normal or hypertonic saline) and if needed supplemental oxygen. The 30 minute MetaNeb treatment session will comprise breathing in and out of the mouthpiece for 5x 5 minute cycles of MetaNeb® therapy (2.5 mins each of CPEP and CHFO modes) interspersed with 1 minute of sputum clearance using huff and/or cough. This treatment will be used for the first 5 days of the participants inpatient admission. Each participant will have the settings of the MetaNeb® titrated to optimise comfort and these settings will be recorded and used for subsequent treatment sessions. All treatment sessions will occur in the patients room on the Respiratory Ward at Sir Charles Gairdner Hospital (SCGH) and will be conducted by either the PhD candidate or another trained member of the SCGH Cystic Fibrosis (CF) Physiotherapy team.
Intervention code [1] 315360 0
Treatment: Devices
Comparator / control treatment
Participants allocated to the control group will be asked to complete 30 minutes of supervised physiotherapy, twice daily, using their usual airway clearance technique (ACT) for example positive expiratory pressure (PEP) or oscillatory PEP device, and inhaled mucolytics. These sessions will be instructed and supervised by members of the SCGH CF Physiotherapy team that are trained in the study protocol and will be conducted in the patients room on the Respiratory Ward at SCGH.
Control group
Active

Outcomes
Primary outcome [1] 321447 0
Lung clearance index measured via multiple breath washout
Timepoint [1] 321447 0
Admission and day 6 of admission (study completion)
Secondary outcome [1] 374978 0
Impedance of the respiratory system (Zrs) and its two components (respiratory reactance [Xrs] and resistance [Rrs]) using forced oscillation technique
Timepoint [1] 374978 0
On admission and day 6 of admission (study completion)
Secondary outcome [2] 374979 0
Forced expiratory volume in one second (FEV1) via spirometry
Timepoint [2] 374979 0
On admission and day 6 of admission (study completion)
Secondary outcome [3] 374980 0
Sputum expectorated using digital scale to measure sputum wet weight
Timepoint [3] 374980 0
At completion of each airway clearance session and each 24 hours.
Secondary outcome [4] 374981 0
Airway inflammation via sputum neutrophil elastase and interleukin 8 levels
Timepoint [4] 374981 0
On admission and day 6 of admission (study completion)
Secondary outcome [5] 374982 0
Health related quality of life using the Alfred Wellness score (AweScore)
Timepoint [5] 374982 0
On admission and day 6 of admission (study completion)
Secondary outcome [6] 374983 0
Symptoms commonly reported by individuals with CF such as fatigue, dyspnoea, chest wall pain, nausea, dizziness, ease of sputum expectoration and sense of chest congestion using a modified Edmonton Symptom Assessment Scale revised.
Timepoint [6] 374983 0
Pre and post each airway clearance session
Secondary outcome [7] 374984 0
Patient satisfaction with allocated airway clearance technique via a questionnaire created by the study investigators
Timepoint [7] 374984 0
Day 6 (study completion)
Secondary outcome [8] 377436 0
Forced vital capacity (FVC) via spirometry
Timepoint [8] 377436 0
On admission and day 6 of admission (study completion)

Eligibility
Key inclusion criteria
Inclusion criteria will comprise individuals with CF who: (i) are aged 18 years or older, (ii) self-report they produce 30mL or more of sputum per 24 hours and (iii) are currently admitted to SCGH for an acute exacerbation of their CF.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria will comprise: (i) current pregnancy, (ii) current fresh haemoptysis (if a participant has blood stained sputum but not fresh blood, advice will be sought from medical team about suitability for the study), (iii) current or previous pneumothorax within the last 12 months, (iv) current or previous colonisation with Nontuberculous Mycobacteria (NTM) within the last 12 months and (v) the inability to provide written informed consent. Further we will also exclude the very small fraction of individuals who are at any time currently listed for transplant or admitted to the respiratory high dependence/intensive care unit.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/01/2020
Actual
8/02/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
35
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 14830 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 28082 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 303628 0
Charities/Societies/Foundations
Name [1] 303628 0
Institute for Respiratory Health
Country [1] 303628 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
Kent St, Bentley WA 6102
Country
Australia
Secondary sponsor category [1] 303997 0
None
Name [1] 303997 0
Address [1] 303997 0
Country [1] 303997 0
Other collaborator category [1] 280960 0
Hospital
Name [1] 280960 0
Sir Charles Gairdner Hospital
Address [1] 280960 0
Hospital Ave, Nedlands WA 6009
Country [1] 280960 0
Australia
Other collaborator category [2] 280961 0
Charities/Societies/Foundations
Name [2] 280961 0
Telethon Kids Institute
Address [2] 280961 0
Northern Entrance, Perth Children's Hospital, 15 Hospital Ave, Nedlands WA 6009
Country [2] 280961 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304154 0
Sir Charles Gairdner and Osborne Park Health Care Group Human Research Ethics Committee
Ethics committee address [1] 304154 0
Level 2 A Block, Hospital Ave, Nedlands, WA 6009
Ethics committee country [1] 304154 0
Australia
Date submitted for ethics approval [1] 304154 0
10/09/2019
Approval date [1] 304154 0
15/10/2019
Ethics approval number [1] 304154 0
RGS0000003485

Summary
Brief summary

This project will look at the effects of twice daily treatment using a new airway clearance device called the MetaNeb®, on lung function, secretion clearance and CF related symptoms compared to twice daily treatment using usual ACT in adults with CF who are hospitalised with a respiratory exacerbation. We hypothesise that in adults with CF, hospitalised with a respiratory exacerbation, twice daily MetaNeb® treatment, compared with usual ACT, will produce greater improvements in lung function, secretion clearance, health-related quality of life (HRQoL) and respiratory signs and symptoms. If this device is shown to be more effective than the commonly used techniques, this would be of great clinical significance as it will assist in guiding clinical use of the device throughout CF centres in Australia and internationally.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 95986 0
Miss Naomi Chapman
Address 95986 0
Physiotherapy Department, Ground Floor A block
Sir Charles Gairdner Hospital
Verdun Street
Nedlands WA 6009
Country 95986 0
Australia
Phone 95986 0
+61 08 6457 2337
Fax 95986 0
Email 95986 0
[email protected]
Contact person for public queries
Name 95987 0
Miss Naomi Chapman
Address 95987 0
Physiotherapy Department, Ground Floor A block
Sir Charles Gairdner Hospital
Verdun Street
Nedlands WA 6009
Country 95987 0
Australia
Phone 95987 0
+61 08 6457 2337
Fax 95987 0
Email 95987 0
[email protected]
Contact person for scientific queries
Name 95988 0
Miss Naomi Chapman
Address 95988 0
Physiotherapy Department, Ground Floor A block
Sir Charles Gairdner Hospital
Verdun Street
Nedlands WA 6009
Country 95988 0
Australia
Phone 95988 0
+61 08 6457 2337
Fax 95988 0
Email 95988 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.