跳至主要内容
临床试验/NCT07755969
NCT07755969尚未招募不适用

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

Vitaz1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2026年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
Vitaz
入组人数
200
试验地点
1
主要终点
Tracheo(s)tomy-related ICU readmission

研究概览

简要总结

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?

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • Ambulatory care
  • Day hospitalisation

研究组 & 干预措施

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.

干预措施: The implementation of the specialised multidisciplinary tracheostomy team. (Other)

结局指标

主要结局

Tracheo(s)tomy-related ICU readmission

时间窗: 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

时间窗: 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

时间窗: through study completion, an average of 1 year

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

Performance of FEES

时间窗: through study completion, an average of 1 year

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

次要结局

  • 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)

研究者

发起方
Vitaz
申办方类型
Other
责任方
Sponsor

研究点 (1)

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