Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

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

6 augustus 2026 bijgewerkt door: 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?

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Observationeel

Inschrijving (Geschat)

200

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • België
    • Oost-Vlaanderen
      • Sint-Niklaas, Oost-Vlaanderen, België, 9100
        • Vitaz
        • Contact:
        • Hoofdonderzoeker:
          • Brecht Serraes, Doctor

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind
  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Kanssteekproef

Studie Bevolking

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.

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
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.
Ander: The 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Tracheo(s)tomy-related ICU readmission
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Total hospital length of stay
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: through study completion, an average of 1 year
Location and discipline responsible for tracheostomy placement.
through study completion, an average of 1 year

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Vitaz

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 augustus 2026

Primaire voltooiing (Geschat)

31 december 2026

Studie voltooiing (Geschat)

31 maart 2027

Studieregistratiedata

Eerst ingediend

24 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria

6 augustus 2026

Eerst geplaatst (Werkelijk)

10 augustus 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

10 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

6 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • EC26004 (Andere identificatie: VITAZ, commissie voor medische ethiek)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Bestudeer gegevens/documenten

  1. Study location: VITAZ

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren