Reliability of MIE PCF

• Research type

  Research Study

• Full title

  Accuracy of peak cough flow measurements using a mechanical insufflator-exsufflator in patients with neuromuscular disease

• IRAS ID

  272851

• Contact name

  Patrick Murphy

• Contact email

  patrick.murphy@gstt.nhs.uk

• Sponsor organisation

  Guy's and St Thomas' Foundation NHS Trust

• Duration of Study in the UK

  0 years, 6 months, 1 days

• Research summary

  Patients with a neuromuscular disease (NMD) lose strength in their breathing muscles which leads to an inability to generate an effective cough. Peak Cough Flow (PCF)is a simple objective measure of cough and is the recommended measure in patients with NMD. Critical peak cough flow values are used to evaluate cough, these include PCF less than 160 L/min to indicate an ineffective cough, PCF between 161- 270 to indicate an impaired cough and PCF greater than 270 L/min to indicate an effective cough. Mechanical insufflator- exsufflator (MIE) devices more commonly known as 'cough assist' devices have an inbuilt measure of PCF however they aren't currently recommended for use to due to limited information available regarding their accuracy.

  The overall aim of this study is to evaluate the accuracy of cough assist devices PCF measurements during usual care in patients with NMD. The questions it seeks to answer includes

  - What is the agreement of cough assist PCF measures with the gold standard pneumotachograph
  - What is the variability of repeated measures in patients receiving more than one cycle of cough assist

  As it will be the first study to accurately measure PCF during cough assist interventions using a pneumotachograph it also seeks to to answer the following questions

  - What proportion of interventions improve cough to an effective level (i.e PCF greater than 270 L/min) ?
  - What is treatment effect size being achieved during usual cough assist interventions

  Finally it will aim to understand patients experience of cough assist by asking them to rate the presence of chest secretions before and after treatment using a visual scale

  Patients with slowly progressive or stable neuromuscular disease related respiratory failure will be included in the study. Participation will involve one visit during their admission to the Lane Fox Respiratory Unit, each lasting approximately an hour.

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  20/LO/0360

• Date of REC Opinion

  5 Mar 2020

• REC opinion

  Favourable Opinion