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
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 laryn...
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BMJ Publishing Group
2024-03-01
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| Series: | BMJ Open Respiratory Research |
| Online Access: | https://bmjopenrespres.bmj.com/content/11/1/e001599.full |
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| author | Stephanie K Mansell Swapna Mandal Amar Shah Francesca Gowing Rhiannon Parry Charlotte Greenfield Yogesh Bhatt |
| author_facet | Stephanie K Mansell Swapna Mandal Amar Shah Francesca Gowing Rhiannon Parry Charlotte Greenfield Yogesh Bhatt |
| author_sort | Stephanie K Mansell |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-dbed5d5f6f474c99822d50267dd0eeab |
| institution | DOAJ |
| issn | 2052-4439 |
| language | English |
| publishDate | 2024-03-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open Respiratory Research |
| spelling | doaj-art-dbed5d5f6f474c99822d50267dd0eeab2025-08-20T02:41:10ZengBMJ Publishing GroupBMJ Open Respiratory Research2052-44392024-03-0111110.1136/bmjresp-2022-001599Pilot 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 descriptionStephanie K Mansell0Swapna Mandal1Amar Shah2Francesca Gowing3Rhiannon Parry4Charlotte Greenfield5Yogesh Bhatt62 Royal Free London NHS Foundation Trust, London, UKUniversity College London, London, UKUSAID India Mission, New Delhi, Delhi, IndiaDepartment of Health Sciences, Brunel University of London, Uxbridge, UKRoyal Free London NHS Foundation Trust, London, UKRoyal Free London NHS Foundation Trust, London, UKRoyal Free London NHS Foundation Trust, London, UKIntroduction 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.https://bmjopenrespres.bmj.com/content/11/1/e001599.full |
| spellingShingle | Stephanie K Mansell Swapna Mandal Amar Shah Francesca Gowing Rhiannon Parry Charlotte Greenfield Yogesh Bhatt 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 BMJ Open Respiratory Research |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| url | https://bmjopenrespres.bmj.com/content/11/1/e001599.full |
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