Could a vibrating mesh nebuliser help clear airways in Long-Term tracheostomy patients?
NCT ID NCT06834581
First seen Jul 13, 2026 · Last updated Jul 14, 2026 · Updated 1 time
Summary
This pilot study tests whether a vibrating mesh nebuliser works better than a standard jet nebuliser for people who need long-term breathing support through a tube in their windpipe (tracheostomy). The trial will measure how well the lungs work, how easily mucus is cleared, and how breathless patients feel. Twelve adults who are already on a ventilator for at least 6 hours a day will try both devices in random order for 30 hours each.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Vibrating mesh nebuliser
- What this could lead to
- If effective, vibrating mesh nebulisers could become a standard way to deliver inhaled medications and clear mucus in people who need long-term breathing support through a tracheostomy.
- What could go wrong
- This is a very small pilot study with only 12 participants, so results may not apply to all tracheostomy patients. The crossover design is short (30 hours per device), so longer-term benefits or risks remain unknown.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 12 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2025
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Lane Fox Unit, St Thomas' Hospital
London, London, SE1 7EH, United Kingdom