None listed
Conditions
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.
Interventions
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 t
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.
Sponsors
Curtin University
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
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.
Outcome results
None listed