Long-term Tracheostomy Ventilated PatientsEVOLVENCT06834581
Effects of Vibrating Mesh Nebulisation in Patients on Long-term Tracheostomy Ventilation: a Pilot Randomised Crossover Trial
A study testing Vibrating mesh nebuliser and Jet nebuliser in people with Long-term Tracheostomy Ventilated Patients, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Long-term Tracheostomy Ventilated Patients
- What is being tested?
- Vibrating mesh nebuliser and Jet nebuliser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Mar 2025to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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:
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Lane Fox Unit, St Thomas' Hospital
London, London, SE1 7EH
About this study
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
Read the 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.
- Being tested
- Vibrating mesh nebuliser, Jet nebuliser
- Keywords
- vibrating mesh nebuliser, jet nebuliser, long-term tracheostomy ventilated patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vibrating mesh nebuliserDevice
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.
Jet nebuliserDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Vibrating mesh nebulisation then jet nebulisation | Experimental | 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. Receives: Device: Vibrating mesh nebuliser; Device: Jet nebuliser |
| Jet nebulisation then vibrating mesh nebulisation | Experimental | 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. Receives: Device: Vibrating mesh nebuliser; Device: Jet nebuliser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neural Respiratory Drive
Parasternal electromyography, which reflects the load-capacity relationship of the respiratory system, will likely decrease with more effective bronchodilation and secretion clearance.
Measured: At baseline and during both 30 hour nebuliser allocations. Following nebulisation measurements to be made at 15 and 30 minutes
Secondary outcomes (8)
Sputum viscosity
Sputum viscosity will be measured by a single assessor using the Qualitative Sputum Analysis Tool (QSAT) score daily during both 30-hour periods. The QSAT score includes sputum volume, type (mucoid, mucopurulent and purulent) and grades viscosity from 1 (adherent) to 4 (easily pourable) in 0.5 increments.
Measured: Daily during both 30 hour periods
Sputum weight
24 hour cumulative wet sputum weight will be measured at baseline and during each nebuliser phase
Measured: At baseline and during both 30 hour nebuliser periods
Heart rate
Heart rate will be assessed by continuous ECG monitoring to detect changes following administration of salbutamol and hypertonic saline by VMN versus JN. Heart rate will be measured in beats per minute.
Measured: At baseline and during 2 x 30 hour periods
Respiratory Flow
Assessment of respiratory flow via pneumotach within both 30 hour time periods
Measured: At baseline and during each 30 hour time period
Symptoms of breathlessness (modified Borg dyspnea scale)
Patient perception of breathlessness will be assessed using the modified Borg dyspnoea scale (mBorg). The scale ranges from 0 to 10 (whole numbers plus 0.5), where 0 indicates no breathing difficulty and 10 represents maximal breathing difficulty.
Measured: At baseline and during both 30 hour nebulisation periods
Symptoms of breathlessness (numerical rating scale)
Patient perception of breathlessness will be assessed using a numerical rating scale from 0 to 10, where 0 represents no breathlessness and 10 represents the worst breathlessness imaginable.
Measured: At baseline and during both 30 hour nebulisation periods
Symptoms of sputum burden
Patient perception of secretion burden will be assessed using a numerical rating scale rated from 0 to 10, where 0 represents no burdensome secretions and 10 represents secretions being the worst imaginable.
Measured: At baseline and during both 30 hour nebulization periods
Heart Rhythm
Changes in heart rhythm will be assessed by ECG monitoring to detect variations following administration of salbutamol and hypertonic saline by VMN versus JN. Any changes in heart rhythm or arrhythmias will be documented.
Measured: At baseline and during the 2 x 30 hour periods
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2025
- Study start20 Mar 2025
- Primary completion10 Sep 2025
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Long-term Tracheostomy Ventilated PatientsStudies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Pilot randomised crossover trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eui Sik Suh, MBBS MChem(Oxon) PhD FRCP, Principal investigator, Guy's and St Thomas' NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06834581
- Sponsor's protocol ID
- 348268
- Acronym
- EVOLVE
- Status last verified
- Jul 2026
- First submitted
- 6 Feb 2025
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37590203Kellett F, Redfern J, Niven RM. Evaluation of nebulised hypertonic saline (7%) as an adjunct to physiotherapy in patients with stable bronchiectasis. Respir Med. 2005 Jan;99(1):27-31. doi: 10.1016/j.rmed.2004.05.006.
PubMed 15672845Tarrant BJ, Le Maitre C, Romero L, Steward R, Button BM, Thompson BR, Holland AE. Mucoactive agents for chronic, non-cystic fibrosis lung disease: A systematic review and meta-analysis. Respirology. 2017 Aug;22(6):1084-1092. doi: 10.1111/resp.13047. Epub 2017 Apr 11.
PubMed 28397992Anand R, McAuley DF, Blackwood B, Yap C, ONeill B, Connolly B, Borthwick M, Shyamsundar M, Warburton J, Meenen DV, Paulus F, Schultz MJ, Dark P, Bradley JM. Mucoactive agents for acute respiratory failure in the critically ill: a systematic review and meta-analysis. Thorax. 2020 Aug;75(8):623-631. doi: 10.1136/thoraxjnl-2019-214355. Epub 2020 Jun 8.
PubMed 32513777Mifsud 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.
PubMed 26956162
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Vibrating Mesh Nebulisation in Patients on Long-term Tracheostomy Ventilation: a Pilot Randomised Crossover Trial
- ClinicalTrials.gov ID
- NCT06834581
- Acronym / sponsor ID
- EVOLVE / 348268
- Keywords
- vibrating mesh nebuliser, jet nebuliser, long-term tracheostomy ventilated patients
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Study start
- 20 Mar 2025 (actual)
- Primary completion
- 10 Sep 2025 (actual)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 19 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Pilot randomised crossover trial
| Arm | Type | Receives |
|---|---|---|
| Vibrating mesh nebulisation then jet nebulisation | Experimental | Device: Vibrating mesh nebuliser, Device: Jet nebuliserParticipants 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. |
| Jet nebulisation then vibrating mesh nebulisation | Experimental | Device: Vibrating mesh nebuliser, Device: Jet nebuliserParticipants 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (12 listed)
- Severe, non-respiratory organ dysfunction including, but not limited to:
- Acute pulmonary pathology requiring emergency treatment including, but not limited to:
- Severe cognitive impairment
- Psychosocial factors that would preclude completion of the study protocol
- Previous intolerance of aerosolised hypertonic 3% saline or nebulised salbutamol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vibrating mesh nebuliserVibrating 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 nebulisation then vibrating mesh nebulisation, Vibrating mesh nebulisation then jet nebulisation |
| Jet nebuliserJet 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. | Device | Jet nebulisation then vibrating mesh nebulisation, Vibrating mesh nebulisation then jet nebulisation |
Primary outcome
Neural Respiratory Drive
Time frame: 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.
8 secondary outcomes
Sputum viscosity
Time frame: Daily during both 30 hour periods
Sputum weight
Time frame: At baseline and during both 30 hour nebuliser periods
Heart rate
Time frame: At baseline and during 2 x 30 hour periods
Respiratory Flow
Time frame: At baseline and during each 30 hour time period
Symptoms of breathlessness (modified Borg dyspnea scale)
Time frame: At baseline and during both 30 hour nebulisation periods
Symptoms of breathlessness (numerical rating scale)
Time frame: At baseline and during both 30 hour nebulisation periods
Symptoms of sputum burden
Time frame: At baseline and during both 30 hour nebulization periods
Heart Rhythm
Time frame: At baseline and during the 2 x 30 hour periods
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Background: PubMed 37590203Arnott 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.
- Background: PubMed 15672845Kellett F, Redfern J, Niven RM. Evaluation of nebulised hypertonic saline (7%) as an adjunct to physiotherapy in patients with stable bronchiectasis. Respir Med. 2005 Jan;99(1):27-31. doi: 10.1016/j.rmed.2004.05.006.
- Background: PubMed 28397992Tarrant BJ, Le Maitre C, Romero L, Steward R, Button BM, Thompson BR, Holland AE. Mucoactive agents for chronic, non-cystic fibrosis lung disease: A systematic review and meta-analysis. Respirology. 2017 Aug;22(6):1084-1092. doi: 10.1111/resp.13047. Epub 2017 Apr 11.
- Background: PubMed 32513777Anand R, McAuley DF, Blackwood B, Yap C, ONeill B, Connolly B, Borthwick M, Shyamsundar M, Warburton J, Meenen DV, Paulus F, Schultz MJ, Dark P, Bradley JM. Mucoactive agents for acute respiratory failure in the critically ill: a systematic review and meta-analysis. Thorax. 2020 Aug;75(8):623-631. doi: 10.1136/thoraxjnl-2019-214355. Epub 2020 Jun 8.
- Background: PubMed 26956162Mifsud 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eui Sik Suh, MBBS MChem(Oxon) PhD FRCP principal investigator
Guy's and St Thomas' NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vibrating mesh nebuliser and Jet nebuliser in people with Long-term Tracheostomy Ventilated Patients, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neural Respiratory Drive (time frame: At baseline and during both 30 hour nebuliser allocations. Following nebulisation measurements to be made at 15 and 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06834581, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.