NCT06834581

Effects of Vibrating Mesh Nebulisation in Patients on Long-term Tracheostomy Ventilation: a Pilot Randomised Crossover Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Guy's and St Thomas' NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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 Participants will be recruited as inpatients within the Lane Fox Unit. Following consent for trial involvement, there will be a 24-hour washout period receiving normal saline nebulisers. Baseline data including ventilator settings, anthropometrics and clinical observations will be recorded before participants are randomly allocated to receive salbutamol and hypertonic (3%) saline via either VMN or JN four times per day for 30 hours. During this period, measurements will include: Neural respiratory drive (via parasternal EMG) Carbon dioxide levels (via forehead probe) Breathlessness and sputum burden (using numerical scales) 24-hour sputum volume with samples for bacterial/viral analyses Following a 24-hour washout period, participants will receive salbutamol and hypertonic saline via the alternative nebuliser type for 30 hours, with identical data collection.

Conditions

• Long-term Tracheostomy Ventilated Patients

Interventions

Type	Name	Description
DEVICE	Vibrating mesh nebuliser	Vibrating mesh nebulisation (VMN) uses a mesh membrane that oscillates at high frequency (typically 128 kHz) to produce a stream of drug-carrying droplets of pre-determined size to be inhaled.
DEVICE	Jet nebuliser	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.

Timeline

• Start date: 2025-03-01
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2025-02-19
• Last updated: 2025-03-03

Locations

1 site across 1 country: United Kingdom