Optimisation of mechanical insufflation:exsufflation v1.0

  • Research type

    Research Study

  • Full title

    Investigating methods to improve secretion clearance using mechanical insufflation:exsufflation in patients with neuromuscular disease.

  • IRAS ID

    255312

  • Contact name

    Patrick Murphy

  • Contact email

    patrick.murphy@gstt.nhs.uk

  • Sponsor organisation

    Guy's and St Thomas Hospital

  • Duration of Study in the UK

    2 years, 6 months, 1 days

  • Research summary

    Patients with neuromuscular diseases (NMD) can suffer from a range of respiratory problems due to respiratory muscle weakness. Cough muscle weakness means secretion clearance from the airways can be problematic, a source of infection, and importantly a cause of death, in this patient group. Therefore, these patients are often supported with devices to aid clearance, such as mechanical insufflation-exsufflation (MIE). Although evidence supports the use of these devices, the optimal technique or settings on the device are not clear. Increasingly, higher pressures are used during MIE and recent work has demonstrated that there may be a physiological benefit to this. However, higher pressures increase the risk of causing lung collapse and may cause detriment to blood flow back to the heart, which is important as NMD patients frequently have concurrent heart muscle weakness. Further, recent work has demonstrated that higher pressures can cause closure of the throat, which is counter-productive in secretion clearance.

    The overall aim of this study is to investigate methods to manipulate MIE to improve secretion clearance in patients with NMD. The questions it seeks to answer are:

    (i) how can we maximally improve lung recruitment during inspiration, whilst maintaining patient comfort and lower pressures
    (ii) what is the smallest pressure difference required in expiration to achieve an improvement in cough
    (iii) do these proposed changes to MIE also cause throat closure
    (iv) what factors do patients believe contribute to their adherence to MIE therapy?

    Patients with slowly progressive or stable neuromuscular diseases will be included in the study. Participation will involve two visits to the Lane Fox Respiratory Unit, each lasting approximately four hours. Patients will be recruited from specialist neuromuscular respiratory clinics by their clinical teams.

    The study is funded by Breas Medical.

  • REC name

    London - Harrow Research Ethics Committee

  • REC reference

    19/LO/1257

  • Date of REC Opinion

    30 Sep 2019

  • REC opinion

    Further Information Favourable Opinion