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

NCT07755969 | Not Yet Recruiting

• 1 other identifier: EC26004
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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?

Conditions

Tracheostomy Patients; Multidisciplinary Care Team; Outcomes; Hospital

Keywords

Multidisciplinary tracheostomy team; Tracheostomy care; Hospitalised patients with a tracheostomy; Retrospective study; Clinical outcomes; Trachea cannula; tracheostomy related care

Outcome Measures

Primary Outcomes (4)

• Tracheo(s)tomy-related ICU readmission

  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

  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

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

  through study completion, an average of 1 year

• Performance of FEES

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

  through study completion, an average of 1 year

Secondary Outcomes (8)

• 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

Study Arms (2)

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.

Other: The implementation of the specialised multidisciplinary tracheostomy team.

Interventions

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.

Post-intervention cohort: After specialised tracheostomy team implementation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• Ambulatory care
• Day hospitalisation

Sponsors & Collaborators

• Vitaz: lead

Study Sites (1)

VITAZ

Sint-Niklaas, Oost-Vlaanderen, 9100, Belgium

Location

Related Publications (6)

• Speed L, Harding KE. Tracheostomy teams reduce total tracheostomy time and increase speaking valve use: a systematic review and meta-analysis. J Crit Care. 2013 Apr;28(2):216.e1-10. doi: 10.1016/j.jcrc.2012.05.005. Epub 2012 Aug 27.

  PMID: 22951017 BACKGROUND

• Parker V, Giles M, Shylan G, Austin N, Smith K, Morison J, Archer W. Tracheostomy management in acute care facilities--a matter of teamwork. J Clin Nurs. 2010 May;19(9-10):1275-83. doi: 10.1111/j.1365-2702.2009.03155.x. Epub 2010 Mar 18.

  PMID: 20345835 BACKGROUND

• Ninan A, Grubb LM, Brenner MJ, Pandian V. Effectiveness of interprofessional tracheostomy teams: A systematic review. J Clin Nurs. 2023 Oct;32(19-20):6967-6986. doi: 10.1111/jocn.16815. Epub 2023 Jul 3.

  PMID: 37395139 BACKGROUND

• Holmes TR, Cumming BD, Sideris AW, Lee JW, Briggs NE, Havas TE. Multidisciplinary Tracheotomy Teams: An Analysis of Patient Outcomes and Resource Allocation. Ear Nose Throat J. 2019 Apr-May;98(4):232-237. doi: 10.1177/0145561319840103. Epub 2019 Apr 2.

  PMID: 30939910 BACKGROUND

• Garrubba M, Turner T, Grieveson C. Multidisciplinary care for tracheostomy patients: a systematic review. Crit Care. 2009;13(6):R177. doi: 10.1186/cc8159. Epub 2009 Nov 6.

  PMID: 19895690 BACKGROUND

• Brenner MJ, Pandian V, Milliren CE, Graham DA, Zaga C, Morris LL, Bedwell JR, Das P, Zhu H, Lee Y Allen J, Peltz A, Chin K, Schiff BA, Randall DM, Swords C, French D, Ward E, Sweeney JM, Warrillow SJ, Arora A, Narula A, McGrath BA, Cameron TS, Roberson DW. Global Tracheostomy Collaborative: data-driven improvements in patient safety through multidisciplinary teamwork, standardisation, education, and patient partnership. Br J Anaesth. 2020 Jul;125(1):e104-e118. doi: 10.1016/j.bja.2020.04.054. Epub 2020 May 23.

  PMID: 32456776 BACKGROUND

Central Study Contacts

Lisa Christiaens, MSc

CONTACT

+3237606060; brecht.serraes@vitaz.be

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2026
• First Posted: August 10, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: August 10, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)