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NCT Number: NCT07755969

Evaluation of a Specialised Tracheostomy Team for the Management of Patients With a Tracheostomy Cannula 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?

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

VITAZ

Sint-Niklaas, Oost-Vlaanderen, 9100, Belgium

Location contact

Brecht Serraes, Doctor

CONTACT

[email protected]

+3237602039

Brecht Serraes, Doctor

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

The implementation of the specialised multidisciplinary tracheostomy team.

Other

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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, ... .

  4. 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

  1. Total hospital length of stay

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

    From hospital admission until hospital discharge

  2. Use of high-flow oxygen therapy or active humidification

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

    Use of high-flow oxygen therapy and/or active humidification during hospitalisation.

  3. Time to tracheo(s)tomy

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

    Number of days from hospital admission to the performance of the tracheo(s)tomy.

  4. Time from ICU admission to transfer to an inpatient ward

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

    Duration of intensive care unit stay before transfer to an inpatient ward.

  5. Length of ICU stay following canulla-related readmission

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

    Duration of intensive care unit stay following readmission due to cannula-related problems.

  6. Mortality due to cannulla-related complications

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

    Occurrence of death attributable to tracheo(s)tomy- or cannula-related complications.

  7. Use of a speaking valve

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

    Occurrence and use of a speaking valve during hospitalisation.

  8. Responsible medical discipline

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

    Location and discipline responsible for tracheostomy placement.

Study contacts

Contact information is provided by the study sponsor or research team.

Lisa Christiaens, MSc

CONTACT

[email protected]

+3237606060

Sponsors and collaborators

Lead sponsor

Vitaz

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Aug 10, 2026
Registry last updated
Aug 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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