Actively Recruiting

Age: 18Years +
All Genders
ID05189600

Can Waveform and Flow Traces From Mechanical Insufflation: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

N/A

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

This research aims to determine if physiotherapists can use waveform traces from a cough assist machine to identify abnormal airway responses during treatment. It focuses on patients with neuromuscular diseases and studies how different settings of the cough assist device, especially breath and cough pressures, affect patient responses. The goal is to provide clinical guidance to physiotherapists for assessing and managing these airway responses. During the study, participants will undergo breathing tests including spirometry, peak cough flow, and sniff nasal inspiratory pressure to assess baseline lung function and exclude those with breathing conditions. A nasal camera will be used to observe the voice box while the cough assist device is applied via a face mask. The device's waveforms will be recorded and analyzed alongside video recordings to see if voice box responses can be identified from these patterns. The cough assist treatment is delivered by an experienced physiotherapist following established protocols. Participants will be monitored for about 30 minutes each during the study. The main assessments include waveform analysis from the cough assist device and nasal endoscopy video recordings of the voice box. These observations will help researchers better understand patient responses to cough assist therapy. The study involves no additional long-term follow-up but requires participants to complete the breathing tests and allow video and device recordings during the session.

CONDITIONS

Brief 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 but not limited to Motor Neurone Disease (MND), Multiple Sclerosis (MS), and Muscular Dystrophy
  • Age 18 years or older
Not Eligible

You will not qualify if you...

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

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Approximately 30 minutes per participant

Participants undergo mechanical insufflation:exsufflation with waveform and flow trace measurements along with nasal endoscopy video recordings to identify laryngeal responses.

1 visit (in-person)

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

R

R&D Manager

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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Published Research Related To This Trial

Pilot observational cohort study to determine whether waveform and flow traces from mechanical insufflation-exsufflation (MI-E) can be used to identify laryngeal responses to MI-E and thus optimise treatment algorithms in neuromuscular patients in a tertiary centre: a protocol description.

Stephanie K Mansell, Rhiannon Parry, Amar Shah...

https://pubmed.ncbi.nlm.nih.gov/38460974