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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 août 2026 mis à jour par: 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?

Aperçu de l'étude

Type d'étude

Observationnel

Inscription (Estimé)

200

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

    • Oost-Vlaanderen
      • Sint-Niklaas, Oost-Vlaanderen, Belgique, 9100
        • Vitaz
        • Contact:
        • Chercheur principal:
          • Brecht Serraes, Doctor

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Enfant
  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

Méthode d'échantillonnage

Échantillon de probabilité

Population étudiée

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.

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Tracheo(s)tomy-related ICU readmission
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Total hospital length of stay
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: through study completion, an average of 1 year
Location and discipline responsible for tracheostomy placement.
through study completion, an average of 1 year

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 août 2026

Achèvement primaire (Estimé)

31 décembre 2026

Achèvement de l'étude (Estimé)

31 mars 2027

Dates d'inscription aux études

Première soumission

24 juillet 2026

Première soumission répondant aux critères de contrôle qualité

6 août 2026

Première publication (Réel)

10 août 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

10 août 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

6 août 2026

Dernière vérification

1 août 2026

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • EC26004 (Autre identifiant: VITAZ, commissie voor medische ethiek)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Données/documents d'étude

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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