RecruitingACTRN12619001681145

Does the MetaNeb®, a new airway clearance device, change lung function in adults with cystic fibrosis when they are hospitalised for a lung infection?

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


Sponsor

Curtin University

Enrollment

80 participants

Start Date

Feb 8, 2020

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Cystic fibrosis (CF) is a genetic condition that causes thick, sticky mucus to build up in the lungs, making it very difficult to breathe and increasing the risk of serious lung infections. Physiotherapy plays a crucial role in CF management — airway clearance techniques (ACT) are used daily to loosen and clear this mucus. When someone with CF develops a lung infection (exacerbation), they are often admitted to hospital for intensive treatment including intravenous antibiotics and increased physiotherapy. The MetaNeb is a new airway clearance device that combines several techniques in one: it delivers oscillating positive pressure, aerosol medication, and lung expansion therapy simultaneously. This study is comparing twice-daily MetaNeb treatment to the participant's usual airway clearance technique during a hospital admission for a CF lung flare-up. The primary question is whether the MetaNeb clears mucus more effectively and improves lung function better than the standard approach. You may be eligible if you are an adult (18 or older) with cystic fibrosis, currently admitted to hospital with a lung infection, and produce at least 30 mL of sputum per day. Pregnant patients, those with recent significant coughing up of blood, a previous collapsed lung in the past year, or those listed for a lung transplant would not be eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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,

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.


Locations(1)

Sir Charles Gairdner Hospital - Nedlands

WA, Australia

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ACTRN12619001681145


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