Effect of mechanical insufflation-exsufflation for ineffective cough on weaning duration in diseases of the peripheral or central nervous system (MEDINE): study protocol for a randomised controlled trial in a neurological weaning centre
Introduction Patients with neurological or neurosurgical disease can suffer from impaired cough, which may result in life-threatening retention of tracheobronchial secretions, atelectasis, pneumonia and finally death. Due to a lack of alternatives and pathophysiological plausibility, the application...
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2023-07-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/13/7/e071273.full |
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| author | Alexander Seipp Antje Timmer Andreas Klausen Teresa Grimm Martin Groß Oliver Summ Fabian Otto-Sobotka |
| author_facet | Alexander Seipp Antje Timmer Andreas Klausen Teresa Grimm Martin Groß Oliver Summ Fabian Otto-Sobotka |
| author_sort | Alexander Seipp |
| collection | DOAJ |
| description | Introduction Patients with neurological or neurosurgical disease can suffer from impaired cough, which may result in life-threatening retention of tracheobronchial secretions, atelectasis, pneumonia and finally death. Due to a lack of alternatives and pathophysiological plausibility, the application of mechanical insufflation-exsufflation (MI-E) has already become international standard care in neuromuscular disease and spinal cord injury although a lack of evidence for efficacy. High-quality studies to support the use of MI-E in neurological and neurosurgical patients during weaning from mechanical ventilation are missing. The goal of this exploratory study is to display the effect size of MI-E intervention on the duration of mechanical ventilation and additional outcomes.Methods and analysis One hundred adult patients with a cough deficiency or retention of secretion admitted to a neurological intensive care unit (ICU) are planned to be recruited for this randomised controlled trial. Patients are randomised 1:1 to receive either MI-E or best standard care. Observation will take place until discharge from the hospital, death or end of the study period. The primary endpoint of this trial is the duration of mechanical ventilation from randomisation until successful weaning. The outcome will be analysed with Kaplan-Meier estimation and competing risks analyses. Secondary endpoint is the proportion of patients with successful weaning. Further outcomes will include the incidence of hospital-acquired pneumonia, mortality, decannulation rate, length of stay on the ICU and the total score of the Glasgow Coma Scale.Ethics and dissemination The study was approved by the Medical Ethics Committee of the University of Oldenburg. The findings of this study will be submitted for publication in a peer-reviewed journal.Trial registration number DRKS00020981. |
| first_indexed | 2024-03-12T15:22:24Z |
| format | Article |
| id | doaj.art-0338c6b20dba4acb94d1d33efa17fa5c |
| institution | Directory Open Access Journal |
| issn | 2044-6055 |
| language | English |
| last_indexed | 2024-03-12T15:22:24Z |
| publishDate | 2023-07-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj.art-0338c6b20dba4acb94d1d33efa17fa5c2023-08-10T20:05:07ZengBMJ Publishing GroupBMJ Open2044-60552023-07-0113710.1136/bmjopen-2022-071273Effect of mechanical insufflation-exsufflation for ineffective cough on weaning duration in diseases of the peripheral or central nervous system (MEDINE): study protocol for a randomised controlled trial in a neurological weaning centreAlexander Seipp0Antje Timmer1Andreas Klausen2Teresa Grimm3Martin Groß4Oliver Summ5Fabian Otto-Sobotka6Epidemiology and Biometry, Carl von Ossietzky University of Oldenburg Faculty VI Medicine and Health Sciences, Oldenburg, GermanyEpidemiology and Biometry, Carl von Ossietzky University of Oldenburg Faculty VI Medicine and Health Sciences, Oldenburg, GermanyBig Data in Medicine, Carl von Ossietzky University of Oldenburg Faculty VI Medicine and Health Sciences, Oldenburg, GermanyDepartment of Neurological Intensive Care and Rehabilitation, Evangelisches Krankenhaus Oldenburg, Oldenburg, GermanyDepartment of Neurological Intensive Care and Rehabilitation, Evangelisches Krankenhaus Oldenburg, Oldenburg, GermanyDepartment of Neurological Intensive Care and Rehabilitation, Evangelisches Krankenhaus Oldenburg, Oldenburg, GermanyEpidemiology and Biometry, Carl von Ossietzky University of Oldenburg Faculty VI Medicine and Health Sciences, Oldenburg, GermanyIntroduction Patients with neurological or neurosurgical disease can suffer from impaired cough, which may result in life-threatening retention of tracheobronchial secretions, atelectasis, pneumonia and finally death. Due to a lack of alternatives and pathophysiological plausibility, the application of mechanical insufflation-exsufflation (MI-E) has already become international standard care in neuromuscular disease and spinal cord injury although a lack of evidence for efficacy. High-quality studies to support the use of MI-E in neurological and neurosurgical patients during weaning from mechanical ventilation are missing. The goal of this exploratory study is to display the effect size of MI-E intervention on the duration of mechanical ventilation and additional outcomes.Methods and analysis One hundred adult patients with a cough deficiency or retention of secretion admitted to a neurological intensive care unit (ICU) are planned to be recruited for this randomised controlled trial. Patients are randomised 1:1 to receive either MI-E or best standard care. Observation will take place until discharge from the hospital, death or end of the study period. The primary endpoint of this trial is the duration of mechanical ventilation from randomisation until successful weaning. The outcome will be analysed with Kaplan-Meier estimation and competing risks analyses. Secondary endpoint is the proportion of patients with successful weaning. Further outcomes will include the incidence of hospital-acquired pneumonia, mortality, decannulation rate, length of stay on the ICU and the total score of the Glasgow Coma Scale.Ethics and dissemination The study was approved by the Medical Ethics Committee of the University of Oldenburg. The findings of this study will be submitted for publication in a peer-reviewed journal.Trial registration number DRKS00020981.https://bmjopen.bmj.com/content/13/7/e071273.full |
| spellingShingle | Alexander Seipp Antje Timmer Andreas Klausen Teresa Grimm Martin Groß Oliver Summ Fabian Otto-Sobotka Effect of mechanical insufflation-exsufflation for ineffective cough on weaning duration in diseases of the peripheral or central nervous system (MEDINE): study protocol for a randomised controlled trial in a neurological weaning centre BMJ Open |
| title | Effect of mechanical insufflation-exsufflation for ineffective cough on weaning duration in diseases of the peripheral or central nervous system (MEDINE): study protocol for a randomised controlled trial in a neurological weaning centre |
| title_full | Effect of mechanical insufflation-exsufflation for ineffective cough on weaning duration in diseases of the peripheral or central nervous system (MEDINE): study protocol for a randomised controlled trial in a neurological weaning centre |
| title_fullStr | Effect of mechanical insufflation-exsufflation for ineffective cough on weaning duration in diseases of the peripheral or central nervous system (MEDINE): study protocol for a randomised controlled trial in a neurological weaning centre |
| title_full_unstemmed | Effect of mechanical insufflation-exsufflation for ineffective cough on weaning duration in diseases of the peripheral or central nervous system (MEDINE): study protocol for a randomised controlled trial in a neurological weaning centre |
| title_short | Effect of mechanical insufflation-exsufflation for ineffective cough on weaning duration in diseases of the peripheral or central nervous system (MEDINE): study protocol for a randomised controlled trial in a neurological weaning centre |
| title_sort | effect of mechanical insufflation exsufflation for ineffective cough on weaning duration in diseases of the peripheral or central nervous system medine study protocol for a randomised controlled trial in a neurological weaning centre |
| url | https://bmjopen.bmj.com/content/13/7/e071273.full |
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