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Clinical Trials/NCT07755969
NCT07755969Not yet recruitingNot Applicable

Management of Patients With a Tracheostomy Cannula by a Specialised Team in a Belgium General Hospital: A Retrospective Study

Vitaz1 site in 1 country200 target enrollmentStarted: August 1, 2026Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Vitaz
Enrollment
200
Locations
1
Primary Endpoint
Tracheo(s)tomy-related ICU readmission

Study Overview

Brief Summary

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?

Study Design

Study Type
Observational
Observational Model
Other
Time Perspective
Retrospective

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

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.

Intervention: The implementation of the specialised multidisciplinary tracheostomy team. (Other)

Outcomes

Primary Outcomes

Tracheo(s)tomy-related ICU readmission

Time Frame: through study completion, an average of 1 year

Occurrence of readmission to the intensive care unit due to tracheo(s)tomy cannula-related problems.

Successful decannulation

Time Frame: 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.

Tracheo(s)tomy-related complications

Time Frame: through study completion, an average of 1 year

Occurrence of predefined canulla-related complications, including airway obstruction, wound infection, bleeding, ... .

Performance of FEES

Time Frame: through study completion, an average of 1 year

Performance of a fibreoptic endoscopic evaluation of swallowing (FEES) during hospitalisation.

Secondary Outcomes

  • Total hospital length of stay(through study completion, an average of 1 year)
  • Use of high-flow oxygen therapy or active humidification(through study completion, an average of 1 year)
  • Time to tracheo(s)tomy(through study completion, an average of 1 year)
  • Time from ICU admission to transfer to an inpatient ward(through study completion, an average of 1 year)
  • Length of ICU stay following canulla-related readmission(through study completion, an average of 1 year)
  • Mortality due to cannulla-related complications(through study completion, an average of 1 year)
  • Use of a speaking valve(through study completion, an average of 1 year)
  • Responsible medical discipline(through study completion, an average of 1 year)

Investigators

Sponsor
Vitaz
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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