SETTLE

• Research type

  Research Study

• Full title

  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?

• IRAS ID

  259371

• Contact name

  Stephanie Mansell

• Contact email

  stephanie.mansell1@nhs.net

• Sponsor organisation

  Royal Free Hospital

• Duration of Study in the UK

  2 years, 0 months, 1 days

• Research summary

  Objectives:
  · To establish if physiotherapists can use the waveform traces from the cough assist machine to work out when patients are having an airway response to cough assist
  · To establish how cough assist device settings, particularly in breath and cough pressures affect a patient’s airway response to cough assist
  · To provide some clinical guidance to physiotherapists on methods for assessing and treating airways responses to cough assist

  Methodology:
  20 participants will be selected for the study
  Subjects will complete breathing tests ; spirometry, peak cough flow (PCF) and sniff nasal inspiratory pressure (SNIP) to establish baseline function and rule out anyone with breathing conditions. A nasal camera will be used to look at the voice box at rest.
  Cough assist will be delivered via a face mask which will allow for simultaneous use of the nasal camera and cough assist carried out in the same way as another team have done previously. The nasal camera will be attached to a video camera to allow recording, analysis and documentation of the observations. The cough assist protocol will be delivered by a physiotherapist experienced in delivering cough assist. Cough assist waveforms will be downloaded into Care Orchestrator software (Philips Respironics, Murraysville, USA) and reviewed at the same time as the nose camera recordings to establish if voice box responses can be identified from the waveform patterns. For confirmation of Care Orchestrator software waveforms, a device that records airflow during breathing (spirometer) will be connected (Alpha touch, Vitalograph, Ennis, Ireland) into the cough assist circuit in the same way another team has before.
  

• REC name

  East of England - Cambridge Central Research Ethics Committee

• REC reference

  21/EE/0233

• Date of REC Opinion

  18 Nov 2021

• REC opinion

  Further Information Favourable Opinion