Tracheostomy PatientsNCT07755969
Evaluation of a Specialised Tracheostomy Team for the Management of Patients With a Tracheostomy Cannula in a Belgium General Hospital: A Retrospective Study.
An observational study of Tracheostomy Patients and Multidisciplinary Care Team, run by Vitaz at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Tracheostomy Patients, Multidisciplinary Care Team, Outcomes
- What is being tested?
- The implementation of the specialised multidisciplinary tracheostomy team.
- How many people
- 200 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Aug 2026to 31 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Ambulatory care
- Day hospitalisation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site
VITAZ
Sint-Niklaas, Oost-Vlaanderen, 9100
Brecht Serraes, Doctor, +3237602039, brecht.serraes@vitaz.be
Brecht Serraes, Doctor
About this study
Official title: 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.
Read more
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
- Being tested
- The implementation of the specialised multidisciplinary tracheostomy team.
- Keywords
- Multidisciplinary tracheostomy team, Tracheostomy care, Hospitalised patients with a tracheostomy, Retrospective study, Clinical outcomes, Trachea cannula, tracheostomy related care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: The implementation of the specialised multidisciplinary tracheostomy team. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tracheo(s)tomy-related ICU readmission
Occurrence of readmission to the intensive care unit due to tracheo(s)tomy cannula-related problems.
Measured: 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.
Measured: 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, ... .
Measured: through study completion, an average of 1 year
Performance of FEES
Performance of a fibreoptic endoscopic evaluation of swallowing (FEES) during hospitalisation.
Measured: through study completion, an average of 1 year
Secondary outcomes (8)
Total hospital length of stay
From hospital admission until hospital discharge
Measured: through study completion, an average of 1 year
Use of high-flow oxygen therapy or active humidification
Use of high-flow oxygen therapy and/or active humidification during hospitalisation.
Measured: through study completion, an average of 1 year
Time to tracheo(s)tomy
Number of days from hospital admission to the performance of the tracheo(s)tomy.
Measured: through study completion, an average of 1 year
Time from ICU admission to transfer to an inpatient ward
Duration of intensive care unit stay before transfer to an inpatient ward.
Measured: through study completion, an average of 1 year
Length of ICU stay following canulla-related readmission
Duration of intensive care unit stay following readmission due to cannula-related problems.
Measured: through study completion, an average of 1 year
Mortality due to cannulla-related complications
Occurrence of death attributable to tracheo(s)tomy- or cannula-related complications.
Measured: through study completion, an average of 1 year
Use of a speaking valve
Occurrence and use of a speaking valve during hospitalisation.
Measured: through study completion, an average of 1 year
Responsible medical discipline
Location and discipline responsible for tracheostomy placement.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start1 Aug 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Tracheostomy PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vitaz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07755969
- Sponsor's protocol ID
- EC26004
- Other IDs
- EC26004
- Status last verified
- Aug 2026
- First submitted
- 24 Jul 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 22951017Parker 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.
PubMed 20345835Ninan 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.
PubMed 37395139Holmes 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.
PubMed 30939910Garrubba 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.
PubMed 19895690Brenner 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.
PubMed 32456776
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Patients With a Tracheostomy Cannula by a Specialised Team in a Belgium General Hospital: A Retrospective Study
- ClinicalTrials.gov ID
- NCT07755969
- Acronym / sponsor ID
- EC26004
- 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
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- VitazUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 10 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Other: The implementation of the specialised multidisciplinary tracheostomy team.Hospitalised patients with a tracheostomy cannula who received care after the establishment and implementation of the specialised multidisciplinary tracheostomy team. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Ambulatory care
- Day hospitalisation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Post-intervention cohort: After specialised tracheostomy team implementation |
Primary outcome
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.
8 secondary outcomes
Total hospital length of stay
Time frame: through study completion, an average of 1 year
Use of high-flow oxygen therapy or active humidification
Time frame: through study completion, an average of 1 year
Time to tracheo(s)tomy
Time frame: through study completion, an average of 1 year
Time from ICU admission to transfer to an inpatient ward
Time frame: through study completion, an average of 1 year
Length of ICU stay following canulla-related readmission
Time frame: through study completion, an average of 1 year
Mortality due to cannulla-related complications
Time frame: through study completion, an average of 1 year
Use of a speaking valve
Time frame: through study completion, an average of 1 year
Responsible medical discipline
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Background: PubMed 22951017Speed 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.
- Background: PubMed 20345835Parker 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.
- Background: PubMed 37395139Ninan 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.
- Background: PubMed 30939910Holmes 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.
- Background: PubMed 19895690Garrubba 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.
- Background: PubMed 32456776Brenner 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tracheostomy Patients and Multidisciplinary Care Team, run by Vitaz at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lisa Christiaens, MSc (+3237606060, brecht.serraes@vitaz.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tracheo(s)tomy-related ICU readmission (time frame: through study completion, an average of 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07755969, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.