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. 2024 Mar 9;11(1):e001599.
doi: 10.1136/bmjresp-2022-001599.

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  1   2 , Rhiannon Parry  3 , Amar Shah  3   2 , Francesca Gowing  3 , Charlotte Greenfield  3 , Yogesh Bhatt  3 , Swapna Mandal  3   2
Affiliations

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 et al. BMJ Open Respir Res. .

Abstract

Introduction: Patients with neuromuscular disease often have a weak and ineffective cough due to respiratory muscle weakness. One treatment option is mechanical insufflation-exsufflation (MI-E), also known as cough assist, which is known to increase cough strength. However, some patients have a laryngeal response to MI-E, which can make the treatment ineffective. Currently, the only method for assessing this is via nasal endoscopy while using MI-E. Some MI-E devices have onboard secure data (SD) cards, which allow the visualisation of waveforms. We hypothesise that the waveforms can be used to identify laryngeal responses to the MI-E.

Methods and analysis: Participants will complete baseline assessments of spirometry, peak cough flow and sniff nasal inspiratory pressure. A nasal endoscope will be used to visualise the larynx during simultaneous MI-E via a mask with a drilled hole. MI-E will be delivered by an experienced physiotherapist. Four cycles of MI-E at a range of prescriptions will be delivered. MI-E waveforms will be downloaded into Care Orchestrator Essence software (Philips, Murraysville). Data will be collected prospectively and reviewed in a descriptive context, providing trends and potential rationales describing the waveforms in comparison to the nasal endoscope videos.

Ethics and dissemination: This protocol has been reviewed by the East of England-Cambridge Central Research Ethics Committee, who have granted a favourable ethical opinion. The study opened to recruitment in January 2022 and aims to publish trial results in June 2024.

Trial registration number: NCT05189600.

Keywords: Cough/Mechanisms/Pharmacology.

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Conflict of interest statement

Competing interests: SKM: consultancy for Philips Respironics, educational grants from Philips Respironics and Dolby Vivisol, Research grants from Philips Respironics. SM: consultancy for Philips Respironics, educational grants from Dolby Vivisol. AS: educational grants from Dolby Vivisol.

Figures

Figure 1
Figure 1
Mechanical insufflation–-exsufflation waveform example.
Figure 2
Figure 2
(A) Application of the mechanical insufflation–exsufflation device and nasal endoscopy (with consent). (B) Example of images from nasal endoscope (with consent).
See this image and copyright information in PMC

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