- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07755969
Evaluation of a Specialised Tracheostomy Team for the Management of Patients With a Tracheostomy Cannula in a Belgium General Hospital: A Retrospective Study.
Management of Patients With a Tracheostomy Cannula by a Specialised Team in a Belgium General Hospital: A Retrospective Study
Patients admitted to intensive care units (ICUs) frequently require prolonged mechanical ventilation. Difficulties in weaning from mechanical ventilation represent an important indication for performing a tracheotomy, which involves creating a temporary opening in the trachea into which a cannula is inserted. This procedure is often confused with a tracheostomy, in which a permanent stoma is created.
Tracheotomy offers several clinical benefits, including increased patient comfort, reduced sedation requirements, decreased work of breathing, improved oral hygiene, a lower risk of ventilator-associated pneumonia, and lower mortality. With the increasing use of the percutaneous technique, the procedure is increasingly performed by intensivists. Consequently, the number of patients with a tracheostomy cannula in the ICU is increasing.
Following clinical stabilisation, these patients are transferred to inpatient wards throughout the hospital according to their underlying pathology. However, nurses working on these wards encounter tracheostomy-related care less frequently, which may include suctioning, wound care, cannula care, and decannulation.
Despite the availability of clinical procedures and protocols, a lack of knowledge, skills, and confidence in providing safe tracheostomy-related care persists. This increases the risk of complications such as cannula obstruction, infection, hypoxaemia, dislodgement, and bleeding. To address this issue, specialised multidisciplinary tracheostomy teams are increasingly being implemented.
The aim of this retrospective study is to answer the following research question: What is the impact of a specialised multidisciplinary tracheostomy team on clinical outcomes in hospitalised patients with a tracheostomy cannula?
Обзор исследования
Статус
Вмешательство/лечение
Тип исследования
Регистрация (Оцененный)
Контакты и местонахождение
Контакты исследования
- Имя: Lisa Christiaens, MSc
- Номер телефона: +3237606060
- Электронная почта: brecht.serraes@vitaz.be
Места учебы
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Oost-Vlaanderen
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Sint-Niklaas, Oost-Vlaanderen, Бельгия, 9100
- Vitaz
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Контакт:
- Brecht Serraes, Doctor
- Номер телефона: +3237602039
- Электронная почта: brecht.serraes@vitaz.be
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Главный следователь:
- Brecht Serraes, Doctor
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Ребенок
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Метод выборки
Исследуемая популяция
Описание
Inclusion Criteria:
- Hospitalisation between 2010 and 2026 in VITAZ (general hospital, Belgium)
- Age ≥18 years.
- Presence of a tracheostomy cannula (tracheotomy, permanent tracheostomy, or laryngectomy).
- Curative and palliative patients will be included.
Exclusion Criteria:
- Ambulatory care
- Day hospitalisation
Учебный план
Как устроено исследование?
Детали дизайна
Когорты и вмешательства
Группа / когорта |
Вмешательство/лечение |
|---|---|
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Pre-intervention cohort: Before specialised tracheostomy team implementation
Hospitalised patients with a tracheostomy cannula who received routine clinical care before the establishment and implementation of the specialised multidisciplinary tracheostomy team.
This cohort serves as the pre-intervention comparison group.
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Post-intervention cohort: After specialised tracheostomy team implementation
Hospitalised patients with a tracheostomy cannula who received care after the establishment and implementation of the specialised multidisciplinary tracheostomy team.
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The intervention of interest is the implementation of the specialised multidisciplinary tracheostomy team, which provides structured, team-based care for patients with a tracheostomy cannula.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Tracheo(s)tomy-related ICU readmission
Временное ограничение: through study completion, an average of 1 year
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Occurrence of readmission to the intensive care unit due to tracheo(s)tomy cannula-related problems.
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through study completion, an average of 1 year
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Successful decannulation
Временное ограничение: through study completion, an average of 1 year
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Successful decannulation of the tracheo(s)tomy cannula according to predefined criteria derived from the literature.
The proportion of patients achieving successful decannulation will be compared between the pre-intervention and post-intervention cohorts.
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through study completion, an average of 1 year
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Tracheo(s)tomy-related complications
Временное ограничение: through study completion, an average of 1 year
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Occurrence of predefined canulla-related complications, including airway obstruction, wound infection, bleeding, ... .
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through study completion, an average of 1 year
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Performance of FEES
Временное ограничение: through study completion, an average of 1 year
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Performance of a fibreoptic endoscopic evaluation of swallowing (FEES) during hospitalisation.
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through study completion, an average of 1 year
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Total hospital length of stay
Временное ограничение: through study completion, an average of 1 year
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From hospital admission until hospital discharge
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through study completion, an average of 1 year
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Use of high-flow oxygen therapy or active humidification
Временное ограничение: through study completion, an average of 1 year
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Use of high-flow oxygen therapy and/or active humidification during hospitalisation.
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through study completion, an average of 1 year
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Time to tracheo(s)tomy
Временное ограничение: through study completion, an average of 1 year
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Number of days from hospital admission to the performance of the tracheo(s)tomy.
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through study completion, an average of 1 year
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Time from ICU admission to transfer to an inpatient ward
Временное ограничение: through study completion, an average of 1 year
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Duration of intensive care unit stay before transfer to an inpatient ward.
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through study completion, an average of 1 year
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Length of ICU stay following canulla-related readmission
Временное ограничение: through study completion, an average of 1 year
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Duration of intensive care unit stay following readmission due to cannula-related problems.
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through study completion, an average of 1 year
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Mortality due to cannulla-related complications
Временное ограничение: through study completion, an average of 1 year
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Occurrence of death attributable to tracheo(s)tomy- or cannula-related complications.
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through study completion, an average of 1 year
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Use of a speaking valve
Временное ограничение: through study completion, an average of 1 year
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Occurrence and use of a speaking valve during hospitalisation.
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through study completion, an average of 1 year
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Responsible medical discipline
Временное ограничение: through study completion, an average of 1 year
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Location and discipline responsible for tracheostomy placement.
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through study completion, an average of 1 year
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Соавторы и исследователи
Спонсор
Публикации и полезные ссылки
Общие публикации
- Ninan A, Grubb LM, Brenner MJ, Pandian V. Effectiveness of interprofessional tracheostomy teams: A systematic review. J Clin Nurs. 2023 Oct;32(19-20):6967-6986. doi: 10.1111/jocn.16815. Epub 2023 Jul 3.
- Speed L, Harding KE. Tracheostomy teams reduce total tracheostomy time and increase speaking valve use: a systematic review and meta-analysis. J Crit Care. 2013 Apr;28(2):216.e1-10. doi: 10.1016/j.jcrc.2012.05.005. Epub 2012 Aug 27.
- Parker V, Giles M, Shylan G, Austin N, Smith K, Morison J, Archer W. Tracheostomy management in acute care facilities--a matter of teamwork. J Clin Nurs. 2010 May;19(9-10):1275-83. doi: 10.1111/j.1365-2702.2009.03155.x. Epub 2010 Mar 18.
- Holmes TR, Cumming BD, Sideris AW, Lee JW, Briggs NE, Havas TE. Multidisciplinary Tracheotomy Teams: An Analysis of Patient Outcomes and Resource Allocation. Ear Nose Throat J. 2019 Apr-May;98(4):232-237. doi: 10.1177/0145561319840103. Epub 2019 Apr 2.
- Garrubba M, Turner T, Grieveson C. Multidisciplinary care for tracheostomy patients: a systematic review. Crit Care. 2009;13(6):R177. doi: 10.1186/cc8159. Epub 2009 Nov 6.
- Brenner MJ, Pandian V, Milliren CE, Graham DA, Zaga C, Morris LL, Bedwell JR, Das P, Zhu H, Lee Y Allen J, Peltz A, Chin K, Schiff BA, Randall DM, Swords C, French D, Ward E, Sweeney JM, Warrillow SJ, Arora A, Narula A, McGrath BA, Cameron TS, Roberson DW. Global Tracheostomy Collaborative: data-driven improvements in patient safety through multidisciplinary teamwork, standardisation, education, and patient partnership. Br J Anaesth. 2020 Jul;125(1):e104-e118. doi: 10.1016/j.bja.2020.04.054. Epub 2020 May 23.
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Другие идентификационные номера исследования
- EC26004 (Другой идентификатор: VITAZ, commissie voor medische ethiek)
Планирование данных отдельных участников (IPD)
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Данные исследования/документы
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .