VITAZ
Sint-Niklaas, Oost-Vlaanderen, 9100, Belgium
Location contact
Brecht Serraes, Doctor
CONTACT
Brecht Serraes, Doctor
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07755969
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?
Trial opening soon.
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Observational
Sint-Niklaas, Oost-Vlaanderen, 9100, Belgium
Brecht Serraes, Doctor
CONTACT
Brecht Serraes, Doctor
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
Time frame: through study completion, an average of 1 year
Occurrence of predefined canulla-related complications, including airway obstruction, wound infection, bleeding, ... .
Time frame: through study completion, an average of 1 year
Performance of a fibreoptic endoscopic evaluation of swallowing (FEES) during hospitalisation.
Time frame: through study completion, an average of 1 year
From hospital admission until hospital discharge
Time frame: through study completion, an average of 1 year
Use of high-flow oxygen therapy and/or active humidification during hospitalisation.
Time frame: through study completion, an average of 1 year
Number of days from hospital admission to the performance of the tracheo(s)tomy.
Time frame: through study completion, an average of 1 year
Duration of intensive care unit stay before transfer to an inpatient ward.
Time frame: through study completion, an average of 1 year
Duration of intensive care unit stay following readmission due to cannula-related problems.
Time frame: through study completion, an average of 1 year
Occurrence of death attributable to tracheo(s)tomy- or cannula-related complications.
Time frame: through study completion, an average of 1 year
Occurrence and use of a speaking valve during hospitalisation.
Time frame: through study completion, an average of 1 year
Location and discipline responsible for tracheostomy placement.
Contact information is provided by the study sponsor or research team.
Vitaz
Other
Management of Patients With a Tracheostomy Cannula by a Specialised Team in a Belgium General Hospital: A Retrospective Study
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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