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Evaluation of a Specialised Tracheostomy Team for the Management of Patients With a Tracheostomy Cannula in a Belgium General Hospital: A Retrospective Study.

6 de agosto de 2026 atualizado por: Vitaz

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

Tipo de estudo

Observacional

Inscrição (Estimado)

200

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

    • Oost-Vlaanderen
      • Sint-Niklaas, Oost-Vlaanderen, Bélgica, 9100
        • Vitaz
        • Contato:
        • Investigador principal:
          • Brecht Serraes, Doctor

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Filho
  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Método de amostragem

Amostra de Probabilidade

População do estudo

This retrospective study will include adult patients aged ≥18 years who were hospitalised between 2010 and 2026 and had a tracheostomy cannula during their hospitalisation. The study population will include patients with a tracheotomy, permanent tracheostomy, or laryngectomy, irrespective of whether care was provided with curative or palliative intent. Both patients admitted to the intensive care unit and those subsequently transferred to inpatient wards will be included. Patients receiving ambulatory care or day hospitalisation will be excluded.

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

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

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

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Publicações e links úteis

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Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de agosto de 2026

Conclusão Primária (Estimado)

31 de dezembro de 2026

Conclusão do estudo (Estimado)

31 de março de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

24 de julho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

6 de agosto de 2026

Primeira postagem (Real)

10 de agosto de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

10 de agosto de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

6 de agosto de 2026

Última verificação

1 de agosto de 2026

Mais Informações

Termos relacionados a este estudo

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)?

NÃO

Dados/documentos do estudo

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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