Effects of Vibrating Mesh Nebulisation in Patients With COPD During Non-invasive Ventilation (VMN-NIV)

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorGuy's and St Thomas' NHS Foundation Trust

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 volunteers

Qualifiers

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

Design model

Crossover

Treatments tested in this trial

  • Vibrating mesh nebulisation

    Device

    Vibrating 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

    Device

    Jet 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

12 Participants
are divided into 2 treatment groups
Group A: 1st Vibrating mesh nebulisation and 2nd jet nebulisationExperimental treatment 2 interventions
Group B: 1st Jet nebulisation and 2nd vibrating mesh nebulisationExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
NRD assessed on both visits at baseline and 5, 15, 30 and 60 minutes after nebulisation

Secondary outcomes

1

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

Time frame
Both visits at baseline, 5 and 60 minutes post nebulisation therapy.
2

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.

Time frame
At baseline and at 5, 15, 30 and 60 minutes post nebulisation on both visits
3

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.

Time frame
At baseline and at 5, 15, 30 and 60 minutes post nebulisation on both visits
4

Transcutaneous CO2 Monitoring

Continuous transcutaneous carbon dioxide levels will be measured

Time frame
At baseline and for 60 minutes following nebulisation

Other outcomes

1

Arterial blood gas

Allows assessment of the persistence and severity of the respiratory failure in addition to being a safety check.

Time frame
At baseline on first visit

Sponsors and contacts

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