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

NCT06834581 | Not Yet Recruiting

• 1 other identifier: 348268
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Conditions

Long-term Tracheostomy Ventilated Patients

Keywords

vibrating mesh nebuliser; jet nebuliser; long-term tracheostomy ventilated patients

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  Daily during both 30 hour periods

• Sputum weight

  At baseline and during both 30 hour nebuliser periods

• Heart rate

  At baseline and during 2 x 30 hour periods

• Respiratory Flow

  At baseline and during each 30 hour time period

• Symptoms of breathlessness (modified Borg dyspnea scale)

  At baseline and during both 30 hour nebulisation periods

Study Arms (2)

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.

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.

Device: Vibrating mesh nebuliser; Device: Jet nebuliser

Interventions

Vibrating mesh nebuliser DEVICE

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 nebulisation then vibrating mesh nebulisation; Vibrating mesh nebulisation then jet nebulisation

Jet nebuliser DEVICE

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.

Jet nebulisation then vibrating mesh nebulisation; Vibrating mesh nebulisation then jet nebulisation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead

Study Sites (1)

Lane Fox Unit, St Thomas' Hospital

London, SE1 7EH, United Kingdom

Location

Related Publications (5)

• 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.

  PMID: 37590203 BACKGROUND

• Kellett 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.

  PMID: 15672845 BACKGROUND

• Tarrant 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.

  PMID: 28397992 BACKGROUND

• Anand 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.

  PMID: 32513777 BACKGROUND

• 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.

  PMID: 26956162 BACKGROUND

Study Officials

• Eui Sik Suh, MBBS MChem(Oxon) PhD FRCP

  Guy's and St Thomas' NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eui-Sik Suh, MBBS MChem(Oxon) PhD FRCP

CONTACT

+44207 188 7727; euisik.suh@gstt.nhs.uk

Gillian Radcliffe

CONTACT

+442071888070; gillian.radcliffe@gstt.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: VMN and JN are easily distinguishable due to both their visible and audible signatures. It is therefore not feasible to blind the patient to the delivered intervention. The mode of nebulisation will be known to both the investigator and participant, and the absence of masking is acknowledged to be a potential source of bias. NRD and spirometry analysis will be masked as off-line analysis.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pilot randomised crossover trial

Study Record Dates

• First Submitted: February 6, 2025
• First Posted: February 19, 2025
• Study Start: March 1, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: March 3, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)