Improving cough assistance for patients with neuromuscular diseases
Investigating Methods to Improve Secretion Clearance Using Mechanical Insufflation:Exsufflation in Patients With Neuromuscular Disease.
NA · Guy's and St Thomas' NHS Foundation Trust · NCT04163198
This study is testing better ways to use cough-assisting machines for people with neuromuscular diseases to help them breathe easier and clear mucus safely.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Guy's and St Thomas' NHS Foundation Trust (other) |
| Locations | 1 site (London) |
| Trial ID | NCT04163198 on ClinicalTrials.gov |
What this trial studies
This study focuses on optimizing the use of mechanical insufflation-exsufflation (MIE) devices for patients with neuromuscular diseases who experience respiratory muscle weakness. It aims to determine the most effective techniques and settings for these devices to enhance airway secretion clearance while minimizing risks such as lung collapse and impaired blood flow. The study will involve patients with stable or slowly progressive neuromuscular conditions and will assess their respiratory function and secretions. By refining the use of MIE, the study seeks to improve patient outcomes in respiratory health.
Who should consider this trial
Good fit: Ideal candidates are adults with stable or slowly progressive neuromuscular diseases and respiratory muscle weakness.
Not a fit: Patients with rapidly progressive neuromuscular diseases or those experiencing decompensated respiratory failure may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly enhance respiratory function and reduce complications for patients with neuromuscular diseases.
How similar studies have performed: While there is existing evidence supporting the use of MIE devices, this specific optimization approach is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
London
- Guys & St. Thomas' NHS Foundation Trust — London, United Kingdom (RECRUITING)
Study contacts
- Study coordinator: Patrick Murphy, PhD
- Email: patrick.murphy@gstt.nhs.uk
- Phone: +442071888070
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.
Conditions: Neuromuscular Diseases