Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT04163198 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Optimisation of Mechanical Insufflation:Exsufflation

Study acronym: MIE2
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Primary completion date: Mar 31, 2025 to Feb 28, 2027
    • Study completion date: May 31, 2025 to Feb 28, 2027
    • Site details revised
    v6
  2. Minor Re-verified, no change to tracked fieldsv5
  3. Notable Primary completion date: Dec 2021 to Mar 31, 2025
    • Study completion date: Apr 2022 to May 31, 2025
    v4
  4. Minor Re-verified, no change to tracked fieldsv3
  5. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Dec 1, 2019 to Dec 19, 2019
    • Site details revised
    v2
  6. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04163198
Lead Sponsor Guy's and St Thomas' NHS Foundation Trust
Collaborators: Royal Brompton & Harefield NHS Foundation Trust
Conditions
(from sponsor)
Neuromuscular Diseases
Related terms Neuromuscular Diseases
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov