Using cough assist devices to improve airway responses in neuromuscular disease patients
Can Waveform and Flow Traces From Mechanical Insuflattion:Exsufflation (MI:E) be Used to Identify Laryngeal Responses to MI:E and Thus Optimise Treatment Algorithms?
This study is testing if physiotherapists can use cough assist machines to better understand and improve how patients with neuromuscular diseases respond when they cough.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Royal Free Hospital NHS Foundation Trust Academic / other |
| Locations | 1 site (London) |
| Trial ID | NCT05189600 on ClinicalTrials.gov |
What this trial studies
This observational study aims to determine if physiotherapists can utilize waveform traces from cough assist machines to identify abnormal airway responses in patients with neuromuscular diseases. It will assess how different settings on the cough assist device, particularly breath and cough pressures, influence patient responses. Participants will undergo breathing tests and use a nasal camera to evaluate their airway function while receiving cough assistance. The goal is to provide clinical guidance for optimizing treatment algorithms for these patients.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with neuromuscular diseases such as Motor Neurone Disease, Multiple Sclerosis, or Muscular Dystrophy.
Not a fit: Patients with obstructive airway diseases or those unable to comply with the study protocol may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the effectiveness of cough assist devices, leading to improved respiratory outcomes for patients with neuromuscular diseases.
How similar studies have performed: While this approach is innovative, similar studies have not been widely reported, indicating that this may be a novel exploration in optimizing cough assist device usage.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with neuromuscular disease(NMD) including but not limited to Motor Neurone Disease (MND), Multiple Sclerosis (MS) and Muscular Dystrophy * Age ≥18 Exclusion Criteria: * Unable to comply with protocol * Unable to give informed consent * Evidence of obstructive airways disease FEV1:FVC \<0.7 * Patients with a history of: * Un-drained pneumothorax * Severe bronchospasm * Head injury with ICP \> 25mmHg * Severe arterial hypotension * Trache-oesophageal fistula * Significant haemoptysis * Facial fractures * Vomiting * Flail segment * Epistaxis within two weeks
Where this trial is running
London
- Royal Free London NHS foundation Trust — London, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Stephanie Mansell
- Email: stephanie.mansell1@nhs.net
- Phone: 0207 794 0500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.