About this trial
Assessment of the effects of vibrating mesh nebulisation versus jet nebulisation on the electrical activity of the muscles involved in breathing (neural respiratory drive), breathing mechanics (respiratory impedance measured by forced oscillation technique), respiratory flow, heart rate and rhythm, spirometry and breathlessness symptoms in patients with chronic obstructive pulmonary disease who require non-invasive ventilation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with COPD receiving home non-invasive ventilation for chronic respiratory failure under the Lane Fox Respiratory Service at Guy's and St Thomas' NHS Foundation Trust
Tolerating home non-invasive ventilation for at least 4 hours/24 hours
Aged 18-80 years old
Able to communicate symptom burden to the research team
Disqualifiers
Congestive cardiac failure
Significant cardiovascular disease
End-stage malignancy
End-stage renal failure
Trial design
Crossover
Treatments tested in this trial
Vibrating mesh nebulisation
DeviceVibrating mesh nebulisation (VMN) uses a mesh membrane that oscillates at high frequency (typically 128kHz) to produce a stream of drug-carrying droplets of pre-determined size to be inhaled
Jet nebuliser
DeviceJet nebulisers use the flow of a gas (air or oxygen) to draw medication up through a capillary tube to generate small particles to be inhaled.
Treatment groups
Trial outcomes
Primary outcomes
Change in neural respiratory drive
Change in neural respiratory drive (NRD) 30 mins following vibrating mesh or jet nebulisation with a bronchodilator (2.5mg salbutamol) during NIV. This will be measured using surface second intercostal space parasternal muscle EMG. This reflects the load-capacity relationship of the respiratory system and will likely decrease with more effective bronchodilation and secretion clearance.
Secondary outcomes
Respiratory System impedence
Change in respiratory system impedance 5 and 60 minutes after vibrating mesh or jet nebulisation therapy with 2.5mg salbutamol during NIV. Respiratory system impedance will be assessed using the forced oscillation technique (FOT). Change in the difference in within-breath respiratory reactance at 5Hz (ΔXrs,5Hz) 5 and 60 minutes after vibrating mesh or jet nebulisation therapy with 2.5mg salbutamol during NIV, as measured by FOT
Symptom of Breathlessness (numerical rating scale)
Breathlessness numerical rating scale: This will allow patients to report their dyspnoea and how it may change with treatment. The scale ranges from 0 to 10, where 0 indicates no breathing difficulty and 10 represents maximal breathing difficulty.
Symptom of Breathlessness (modified Borg Dyspnoea scale)
Patient perception of breathlessness will be assessed using the modified Borg dyspnoea scale (mBorg). The scale ranges from 0 to 10 (whole numbers plus 0.5), where - indicates no breathing difficulty and 10 represents maximal breathing difficulty.
Transcutaneous CO2 Monitoring
Continuous transcutaneous carbon dioxide levels will be measured
Other outcomes
Arterial blood gas
Allows assessment of the persistence and severity of the respiratory failure in addition to being a safety check.
Sponsors and contacts
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