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
© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ..
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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:11 |
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| Enthalten in: |
BMJ open respiratory research - 11(2024), 1 vom: 09. März |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Mansell, Stephanie K [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 11.03.2024 Date Revised 14.03.2024 published: Electronic ClinicalTrials.gov: NCT05189600 Citation Status MEDLINE |
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| doi: |
10.1136/bmjresp-2022-001599 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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NLM369507088 |
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| 245 | 1 | 0 | |a 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 |b a protocol description |
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| 520 | |a © Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a TRIAL REGISTRATION NUMBER: NCT05189600 | ||
| 650 | 4 | |a Journal Article | |
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| 700 | 1 | |a Shah, Amar |e verfasserin |4 aut | |
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| 700 | 1 | |a Greenfield, Charlotte |e verfasserin |4 aut | |
| 700 | 1 | |a Bhatt, Yogesh |e verfasserin |4 aut | |
| 700 | 1 | |a Mandal, Swapna |e verfasserin |4 aut | |
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