- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico 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?
Visão geral do estudo
Status
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: Lisa Christiaens, MSc
- Número de telefone: +3237606060
- E-mail: brecht.serraes@vitaz.be
Locais de estudo
-
-
Oost-Vlaanderen
-
Sint-Niklaas, Oost-Vlaanderen, Bélgica, 9100
- Vitaz
-
Contato:
- Brecht Serraes, Doctor
- Número de telefone: +3237602039
- E-mail: brecht.serraes@vitaz.be
-
Investigador principal:
- Brecht Serraes, Doctor
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
|
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.
|
|
|
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.
|
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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Tracheo(s)tomy-related ICU readmission
Prazo: through study completion, an average of 1 year
|
Occurrence of readmission to the intensive care unit due to tracheo(s)tomy cannula-related problems.
|
through study completion, an average of 1 year
|
|
Successful decannulation
Prazo: through study completion, an average of 1 year
|
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.
|
through study completion, an average of 1 year
|
|
Tracheo(s)tomy-related complications
Prazo: through study completion, an average of 1 year
|
Occurrence of predefined canulla-related complications, including airway obstruction, wound infection, bleeding, ... .
|
through study completion, an average of 1 year
|
|
Performance of FEES
Prazo: through study completion, an average of 1 year
|
Performance of a fibreoptic endoscopic evaluation of swallowing (FEES) during hospitalisation.
|
through study completion, an average of 1 year
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Total hospital length of stay
Prazo: through study completion, an average of 1 year
|
From hospital admission until hospital discharge
|
through study completion, an average of 1 year
|
|
Use of high-flow oxygen therapy or active humidification
Prazo: through study completion, an average of 1 year
|
Use of high-flow oxygen therapy and/or active humidification during hospitalisation.
|
through study completion, an average of 1 year
|
|
Time to tracheo(s)tomy
Prazo: through study completion, an average of 1 year
|
Number of days from hospital admission to the performance of the tracheo(s)tomy.
|
through study completion, an average of 1 year
|
|
Time from ICU admission to transfer to an inpatient ward
Prazo: through study completion, an average of 1 year
|
Duration of intensive care unit stay before transfer to an inpatient ward.
|
through study completion, an average of 1 year
|
|
Length of ICU stay following canulla-related readmission
Prazo: through study completion, an average of 1 year
|
Duration of intensive care unit stay following readmission due to cannula-related problems.
|
through study completion, an average of 1 year
|
|
Mortality due to cannulla-related complications
Prazo: through study completion, an average of 1 year
|
Occurrence of death attributable to tracheo(s)tomy- or cannula-related complications.
|
through study completion, an average of 1 year
|
|
Use of a speaking valve
Prazo: through study completion, an average of 1 year
|
Occurrence and use of a speaking valve during hospitalisation.
|
through study completion, an average of 1 year
|
|
Responsible medical discipline
Prazo: through study completion, an average of 1 year
|
Location and discipline responsible for tracheostomy placement.
|
through study completion, an average of 1 year
|
Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
Publicações Gerais
- 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.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- EC26004 (Outro identificador: VITAZ, commissie voor medische ethiek)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Dados/documentos do estudo
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .