EVOLVE

  • Research type

    Research Study

  • Full title

    Effects of vibrating mesh nebulisation in patients on long-term tracheostomy ventilation: a pilot randomised crossover trial

  • IRAS ID

    348268

  • Contact name

    Eui-Sik Suh

  • Contact email

    euisik.suh@gstt.nhs.uk

  • Sponsor organisation

    Guy's and St Thomas' NHS Foundation Trust

  • Duration of Study in the UK

    2 years, 0 months, 1 days

  • Research summary

    People who require long-term tracheostomy ventilation often have a lot of respiratory secretions. Managing these secretions uses nebulisers as well as suction and other techniques. It is currently unclear if giving medications through different nebuliser technologies has an improved impact on the neural respiratory drive or if it can improve breathing or secretion clearance.

    This study is investigating two types of nebuliser that are currently both used in clinical practice. The two nebulisers a) a jet nebuliser which blows air or oxygen through the liquid medicine to turn it into a spray to be breathed into the lungs b) a vibrating mesh nebuliser that vibrates to create small droplets of the liquid medicine to be breathed into the lungs. Both types of nebulisers are available commercially and have been through extensive safety testing they have different mechanisms of delivering the medication into the lungs.

    This is a feasibility, randomised crossover study which will be conducted at a single site and we are aiming to recruit 12 patients (allowing for 18 participants to allow for drop outs). Participants will be involved for a week during their inpatient admission.

    We are now conducting this study to determine if there is a difference in the mechanics of breathing following being given saline and salbutamol by the two different nebulisers for patients requiring long term tracheostomy ventilation. We hope this study will inform the design and development of a full multi-centre randomised control trial to assess whether giving medications through different nebuliser technologies has a clinical benefit to patients who require long-term tracheostomy ventilation.

  • REC name

    East Midlands - Nottingham 1 Research Ethics Committee

  • REC reference

    25/EM/0007

  • Date of REC Opinion

    21 Jan 2025

  • REC opinion

    Favourable Opinion