Optimisation of Mechanical Insufflation:Exsufflation (MIE2)
Investigating Methods to Improve Secretion Clearance Using Mechanical Insufflation:Exsufflation in Patients With Neuromuscular Disease.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Patrick Murphy, PhD
- Phone Number: +442071888070
- Email: patrick.murphy@gstt.nhs.uk
Study Locations
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London
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London, London, United Kingdom, SE1 7EH
- Recruiting
- Guys & St. Thomas' NHS Foundation Trust
-
Contact:
- Neeraj Shah, MBBS
- Email: neeraj.shah@gstt.nhs.uk
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Stable or slowly progressive neuromuscular disease
- Respiratory muscle weakness (FVC <60%, snip <60%, sleep disordered breathing)
- Clinical evidence of respiratory secretions or cough peak expiratory flow <270 and history of lower respiratory tract infection
- Documented clinical stability by supervising clinician
Exclusion Criteria:
- Rapidly progressive neuromuscular disease (such as motor neuron disease)
- Decompensated respiratory failure (pH < 7.35)
- Pregnancy
- Aged <18
- Change in ventilator settings in preceding 4 weeks
- Significant physical or psychiatric co-morbidity that would prevent compliance with trial protocol
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Insufflation optimisation
Patient will receive different inspiratory time and expiratory time, and inspiratory flow at a fixed insufflation pressure.
To determine how best to recruit lung.
|
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.
|
|
Experimental: Exsufflation optimisation
Patient will receive different expiratory pressures at a fixed inspiratory pressure (optimal determine in Arm 1).
To determine minimum flow bias needed to generate cPEF
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Patients will receive different exsufflation pressures at fixed insufflation pressure.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cough peak expiratory flow (cPEF)
Time Frame: 2 days
|
Change in cPEF with different modalities of MI-E
|
2 days
|
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Patrick Murphy, PhD, Guy's and St Thomas' NHS Foundation Trust
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1.0
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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