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

NCT06884228 | Not Yet Recruiting

• 1 other identifier: 348845
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COPD (Chronic Obstructive Pulmonary Disease); Non-invasive Ventilation

Keywords

vibrating mesh nebuliser; jet nebuliser

Outcome Measures

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.

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

Secondary Outcomes (10)

• Respiratory System impedence

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

• Symptom of Breathlessness (numerical rating scale)

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

• Symptom of Breathlessness (modified Borg Dyspnoea scale)

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

• Transcutaneous CO2 Monitoring

  At baseline and for 60 minutes following nebulisation

• Spirometry - Forced expiratory volume in 1 second

  At baseline and during 1 hour after administration of nebuliser on both visits

Other Outcomes (1)

• Arterial blood gas

  At baseline on first visit

Study Arms (2)

1st Vibrating mesh nebulisation and 2nd jet nebulisation

EXPERIMENTAL

Participants will receive a single dose of salbutamol whilst on NIV via vibrating mesh nebulisation on their first visit. After a minimum 48-hour washout period, they will receive the same dose of salbutamol via jet nebulisation while on NIV.

Device: Vibrating mesh nebulisation; Device: Jet nebuliser

1st Jet nebulisation and 2nd vibrating mesh nebulisation

EXPERIMENTAL

Participants will receive a single dose of salbutamol whilst on NIV via jet nebuliser on their first visit. After a minimum 48-hour washout period, they will receive the same dose of salbutamol via vibrating mesh nebuliser while on NIV.

Device: Vibrating mesh nebulisation; Device: Jet nebuliser

Interventions

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

1st Jet nebulisation and 2nd vibrating mesh nebulisation; 1st Vibrating mesh nebulisation and 2nd jet nebulisation

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.

1st Jet nebulisation and 2nd vibrating mesh nebulisation; 1st Vibrating mesh nebulisation and 2nd jet nebulisation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Able to give informed consent for participation in the study
• Clinical stability, with no acute exacerbations of COPD for 2 weeks prior to enrolment

You may not qualify if:

• Severe, non-respiratory organ dysfunction including, but not limited to:
• Congestive cardiac failure
• Significant cardiovascular disease
• End-stage malignancy
• End-stage renal failure
• Acute pulmonary pathology requiring emergency treatment including, but not limited to:
• Pneumonia
• Pneumothorax
• Pulmonary embolism
• Severe cognitive impairment
• Psychosocial factors that would preclude completion of the study protocol

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead

Study Sites (1)

Lane Fox Unit, St Thomas' Hospital, Guy's and St Thomas' NHS Foundation Trust

London, SE1 7EH, United Kingdom

Location

Related Publications (3)

• Davidson AC, Banham S, Elliott M, Kennedy D, Gelder C, Glossop A, Church AC, Creagh-Brown B, Dodd JW, Felton T, Foex B, Mansfield L, McDonnell L, Parker R, Patterson CM, Sovani M, Thomas L; BTS Standards of Care Committee Member, British Thoracic Society/Intensive Care Society Acute Hypercapnic Respiratory Failure Guideline Development Group, On behalf of the British Thoracic Society Standards of Care Committee. BTS/ICS guideline for the ventilatory management of acute hypercapnic respiratory failure in adults. Thorax. 2016 Apr;71 Suppl 2:ii1-35. doi: 10.1136/thoraxjnl-2015-208209. No abstract available.

  PMID: 26976648 BACKGROUND

• Plant PK, Owen JL, Elliott MW. Early use of non-invasive ventilation for acute exacerbations of chronic obstructive pulmonary disease on general respiratory wards: a multicentre randomised controlled trial. Lancet. 2000 Jun 3;355(9219):1931-5. doi: 10.1016/s0140-6736(00)02323-0.

  PMID: 10859037 BACKGROUND

• Brochard L. Non-invasive ventilation for acute exacerbations of COPD: a new standard of care. Thorax. 2000 Oct;55(10):817-8. doi: 10.1136/thorax.55.10.817. No abstract available.

  PMID: 10992531 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Eui-Sik Suh, MBBS MChem(Oxon) PhD FRCP

  Guy's and St Thomas' NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eui-Sik Suh, MBBS MChem(Oxon) PhD FRCP

CONTACT

+44 207 188 7727; euisik.suh@gstt.nhs.uk

Gillian Radcliffe

CONTACT

+442071888070; gillian.radcliffe@gstt.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: VMN and JN are easily distinguishable due to both their visible and audible signatures. It is therefore not feasible to blind the patient to the delivered intervention. The mode of nebulisation will be known to both the investigator and participant, and the absence of masking is acknowledged to be a potential source of bias. Analysis of NRD and spirometry will be masked as an offline analysis.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pilot randomised crossover trial

Study Record Dates

• First Submitted: February 27, 2025
• First Posted: March 19, 2025
• Study Start: March 21, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: March 19, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)