Effects of Vibrating Mesh Nebulisation in Patients With COPD During Non-invasive Ventilation (VMN-NIV)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Change in neural respiratory drive
研究概览
简要总结
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.
详细描述
Background Chronic obstructive pulmonary disease (COPD) remains a leading cause of morbidity and mortality in the United Kingdom. Acute exacerbations of COPD (AECOPD) frequently necessitate hospitalisation, with standard treatment comprising nebulised bronchodilators, antibiotics, and systemic corticosteroids. Approximately 20% of patients hospitalised with AECOPD require non-invasive ventilation (NIV) to manage decompensated hypercapnic respiratory failure, often necessitating concurrent administration of nebulised therapy.
Home NIV use is increasing among COPD patients to improve respiratory symptoms, quality of life, reduce hospitalisation frequency, and enhance survival. These patients may also require nebulised bronchodilator therapy during NIV, particularly when managing acute exacerbations not severe enough to warrant hospitalisation.
Currently, two nebulisation modalities are used as standard of care for patients on NIV:
Jet nebulisation (JN) - the conventional delivery method Vibrating mesh nebulisation (VMN) - a newer technology that utilises a mesh membrane oscillating at high frequency to produce drug-carrying droplets of predetermined size
VMN has been developed to optimise drug delivery in various patient populations, including those who are spontaneously breathing, receiving invasive mechanical ventilation, or on NIV. This technology is designed to enhance pulmonary drug deposition while minimising residual drug volume post-nebulisation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
1st Vibrating mesh nebulisation and 2nd jet nebulisation
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.
干预措施: Vibrating mesh nebulisation (Device)
1st Vibrating mesh nebulisation and 2nd jet nebulisation
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.
干预措施: Jet nebuliser (Device)
1st Jet nebulisation and 2nd vibrating mesh nebulisation
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.
干预措施: Vibrating mesh nebulisation (Device)
1st Jet nebulisation and 2nd vibrating mesh nebulisation
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.
干预措施: Jet nebuliser (Device)
结局指标
主要结局
Change in neural respiratory drive
时间窗: NRD assessed on both visits at baseline and 5, 15, 30 and 60 minutes after nebulisation
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.
次要结局
- Spirometry - Forced vital capacity(At baseline and during 1 hour after administration of nebuliser on both visits)
- Respiratory flow(At baseline and for 60 minutes following nebulisation)
- Cardiac rhythm(At baseline and for 60 minutes following nebulisation)
- Spirometry ratio - FEV1/FVC(At baseline and during 1 hour after administration of nebuliser on both visits)
- 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)
- Cardiac rate(At baseline and for 60 minutes following nebulisation)