Actively Recruiting

Age: 18Years +
All Genders
NCT05189600

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?

Led by Royal Free Hospital NHS Foundation Trust · Updated on 2024-06-13

20

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

Sponsors

R

Royal Free Hospital NHS Foundation Trust

Lead Sponsor

P

Private Physiotherapy Education Fund

Collaborating Sponsor

AI-Summary

What this Trial Is About

Objectives: * To establish if physiotherapists can use the waveform traces from the cough assist machine to work out when patients are having an abnormal airway response to cough assist * To establish how cough assist device settings, particularly in breath and cough pressures affect a patient's response to using the cough assist device * To provide some clinical guidance to physiotherapists on methods for assessing and treating abnormal airway responses to cough assist devices Methodology: Subjects will complete breathing tests; spirometry, peak cough flow (PCF) and sniff nasal inspiratory pressure (SNIP) to establish baseline breathing 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 research 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 research team has before.

CONDITIONS

Official 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?

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with neuromuscular disease (including Motor Neurone Disease, Multiple Sclerosis, Muscular Dystrophy)
  • Age 18 years or older
Not Eligible

You will not qualify if you...

  • Unable to comply with protocol
  • Unable to give informed consent
  • Evidence of obstructive airways disease with FEV1:FVC ratio less than 0.7
  • History of un-drained pneumothorax
  • Severe bronchospasm
  • Head injury with intracranial pressure greater than 25 mmHg
  • Severe arterial hypotension
  • Trache-oesophageal fistula
  • Significant haemoptysis
  • Facial fractures
  • Vomiting
  • Flail chest segment
  • Epistaxis within two weeks

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Royal Free London NHS foundation Trust

London, United Kingdom, NW3 2QG

Actively Recruiting

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Research Team

S

Stephanie Mansell

CONTACT

R

R&D Manager

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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