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RECRUITING
NCT04163198
NA

Optimisation of Mechanical Insufflation:Exsufflation

Sponsor: Guy's and St Thomas' NHS Foundation Trust

View on ClinicalTrials.gov

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.

Official title: Investigating Methods to Improve Secretion Clearance Using Mechanical Insufflation:Exsufflation in Patients With Neuromuscular Disease.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2019-12-19

Completion Date

2027-02-28

Last Updated

2026-06-04

Healthy Volunteers

No

Interventions

DEVICE

Insufflation

Patients will receive different inspiratory (Ti) and expiratory (Te) times and inspiratory flows, at a fixed insufflation and exsufflation pressure. Optimum insufflation pressure will be determined by measuring maximal inspiratory capacity.

DEVICE

Exsufflation

Patients will receive different exsufflation pressures at fixed insufflation pressure.

Locations (1)

Guys & St. Thomas' NHS Foundation Trust

London, London, United Kingdom