Clinical trial NCT06834581: Effects of Vibrating Mesh Nebulisation in Patients on Long-term Tracheostomy Ventilation: a Pilot Randomised Crossover Trial
Official title: Effects of Vibrating Mesh Nebulisation in Patients on Long-term Tracheostomy Ventilation: a Pilot Randomised Crossover Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Long-term Tracheostomy Ventilated Patients
Keywords: vibrating mesh nebuliser
jet nebuliser
long-term tracheostomy ventilated patients
Lead sponsor: Guy's and St Thomas' NHS Foundation Trust
Sponsor class: OTHER
First posted: 2025-02-19
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Pilot randomised crossover trial
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Neural Respiratory Drive
timeFrame: At baseline and during both 30 hour nebuliser allocations. Following nebulisation measurements to be made at 15 and 30 minutes
Secondary outcomes:
measure: Sputum viscosity
timeFrame: Daily during both 30 hour periods
measure: Sputum weight
timeFrame: At baseline and during both 30 hour nebuliser periods
measure: Heart rate
timeFrame: At baseline and during 2 x 30 hour periods
measure: Respiratory Flow
timeFrame: At baseline and during each 30 hour time period
measure: Symptoms of breathlessness (modified Borg dyspnea scale)
timeFrame: At baseline and during both 30 hour nebulisation periods
measure: Symptoms of breathlessness (numerical rating scale)
timeFrame: At baseline and during both 30 hour nebulisation periods
measure: Symptoms of sputum burden
timeFrame: At baseline and during both 30 hour nebulization periods
measure: Heart Rhythm
timeFrame: At baseline and during the 2 x 30 hour periods
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Lane Fox Unit, St Thomas' Hospital
Study officials:
affiliation: Guy's and St Thomas' NHS Foundation Trust
name: Eui Sik Suh, MBBS MChem(Oxon) PhD FRCP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Arnott A, Hart R, McQueen S, Watson M, Sim M. Prospective randomised unblinded comparison of sputum viscosity for three methods of saline nebulisation in mechanically ventilated patients: A pilot study protocol. PLoS One. 2023 Aug 17;18(8):e0290033. doi: 10.1371/journal.pone.0290033. eCollection 2023.
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citation: Mifsud Bonnici D, Sanctuary T, Warren A, Murphy PB, Steier J, Marino P, Pattani H, Creagh-Brown BC, Hart N. Prospective observational cohort study of patients with weaning failure admitted to a specialist weaning, rehabilitation and home mechanical ventilation centre. BMJ Open. 2016 Mar 8;6(3):e010025. doi: 10.1136/bmjopen-2015-010025.