Effects of Vibrating Mesh Nebulisation in Patients on Long-term Tracheostomy Ventilation: a Pilot… (NCT06834581) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Effects of Vibrating Mesh Nebulisation in Patients on Long-term Tracheostomy Ventilation: a Pilot Randomised Crossover Trial
United Kingdom12 participantsStarted 2025-03-20
Plain-language 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
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Neural Respiratory Drive
Timeframe: At baseline and during both 30 hour nebuliser allocations. Following nebulisation measurements to be made at 15 and 30 minutes