Effects of Vibrating Mesh Nebulisation in Patients on Long-term Tracheostomy Ventilation: a Pilot Randomised Crossover Trial
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
- Neural Respiratory Drive
研究概览
简要总结
Assessment of the effects of vibrating mesh nebulisation versus jet nebulisation on respiratory function in patients with long-term tracheostomy ventilation: evaluating neural respiratory drive, breathing mechanics, cardiac parameters, secretions, and breathlessness
详细描述
Long-term tracheostomy ventilation (LTTV) is frequently complicated by high secretion burden, arising from accumulation of oronasal and bronchial secretions due to impaired bulbar or cough function. Patients are therefore at an increased risk of sputum plugging and respiratory infection, leading to potentially life-threatening deterioration. In patients undergoing weaning from prolonged mechanical ventilation, liberation from invasive mechanical ventilation can be delayed by excessive secretion burden, detrimentally affecting quality of life and escalating healthcare costs.
The principal treatment strategies for secretion retention are oral and tracheal suction, mucolytic therapy (enteral or nebulised) and mechanical insufflation-exsufflation (MIE). There are few robust data to support the use of these treatment modalities, although they are routinely used in clinical practice on an empirical basis. The use of nebulised hypertonic saline is well-established in the management of non-cystic fibrosis bronchiectasis and is frequently used to aid airway clearance in LTTV patients. Nebulised salbutamol is widely used as a bronchodilator in tracheostomised patients with a tendency to develop bronchospasm, whether due to established obstructive airways disease or airways inflammation from secretion retention or ventilator-associated pneumonia.
Vibrating mesh nebulisation (VMN) is increasingly used for aerosol delivery in mechanically ventilated patients, with advantages including reduced residual volume, quieter operation and higher levels of drug deposition. However, its superiority in improving secretion clearance and bronchodilation compared with jet nebulisation (JN) is yet to be established. Both VMN and JN are currently utilised within clinical practice as standards of care.
This pilot randomised crossover trial seeks to recruit 12 patients to establish whether VMN of hypertonic saline and salbutamol has a greater effect than standard JN in improving:
Neural respiratory drive (measured by assessment of the electrical activity of breathing muscles via parasternal EMG) Secretion burden Breathlessness
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
- Single (Outcomes Assessor)
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. NRD and spirometry analysis will be masked as off-line 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 receiving long-term tracheostomy ventilation as inpatients of the Lane Fox Respiratory Service at Guy's and St Thomas' NHS Foundation Trust
- •Requiring prolonged mechanical ventilation for at least 6 hours per day for at least 21 days
- •Has a cuffed tracheostomy in situ
- •Aged 18-80 years old
- •Receiving normal (0.9%) saline or hypertonic saline nebulisation at the time of enrolment into the study
- •Requiring and tolerating tracheal suctioning for secretion management
- •Able to communicate symptom burden to the research team
- •Able to give informed consent for participation in the study
- •Clinical stability, with no requirement for changes in ventilatory support, as assessed by the responsible clinician for at least 48 hours prior to enrolment in study
排除标准
- •Severe, non-respiratory organ dysfunction including, but not limited to:
- •Congestive cardiac failure
- •Cardiac arrhythmia
- •End-stage malignancy
- •End-stage renal failure
- •Acute pulmonary pathology requiring emergency treatment including, but not limited to:
- •Ventilator associated pneumonia at the time of screening
- •Pneumothorax
- •Pulmonary embolism
- •Severe cognitive impairment
- •Psychosocial factors that would preclude completion of the study protocol
- •Previous intolerance of aerosolised hypertonic 3% saline or nebulised salbutamol
研究组 & 干预措施
Vibrating mesh nebulisation then jet nebulisation
Participants will receive hypertonic saline and salbutamol via vibrating mesh nebulisation for the first 30 hours. After a 24-hour washout period, they will receive the same medications via jet nebulisation.
干预措施: Vibrating mesh nebuliser (Device)
Vibrating mesh nebulisation then jet nebulisation
Participants will receive hypertonic saline and salbutamol via vibrating mesh nebulisation for the first 30 hours. After a 24-hour washout period, they will receive the same medications via jet nebulisation.
干预措施: Jet nebuliser (Device)
Jet nebulisation then vibrating mesh nebulisation
Participants will receive hypertonic saline and salbutamol via jet nebulisation for the first 30 hours. After a 24-hour washout period, they will receive the same medications via vibrating mesh nebulisation.
干预措施: Vibrating mesh nebuliser (Device)
Jet nebulisation then vibrating mesh nebulisation
Participants will receive hypertonic saline and salbutamol via jet nebulisation for the first 30 hours. After a 24-hour washout period, they will receive the same medications via vibrating mesh nebulisation.
干预措施: Jet nebuliser (Device)
结局指标
主要结局
Neural Respiratory Drive
时间窗: At baseline and during both 30 hour nebuliser allocations. Following nebulisation measurements to be made at 15 and 30 minutes
Parasternal electromyography, which reflects the load-capacity relationship of the respiratory system, will likely decrease with more effective bronchodilation and secretion clearance.
次要结局
- Sputum viscosity(Daily during both 30 hour periods)
- Sputum weight(At baseline and during both 30 hour nebuliser periods)
- Heart rate(At baseline and during 2 x 30 hour periods)
- Respiratory Flow(At baseline and during each 30 hour time period)
- Symptoms of breathlessness (modified Borg dyspnea scale)(At baseline and during both 30 hour nebulisation periods)
- Symptoms of breathlessness (numerical rating scale)(At baseline and during both 30 hour nebulisation periods)
- Symptoms of sputum burden(At baseline and during both 30 hour nebulization periods)
- Heart Rhythm(At baseline and during the 2 x 30 hour periods)