TRacheostomy in DElphi for iNTensive Care' (TRiDENT)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- Consensus on statements regarding tracheostomy care in critically ill patients
研究概览
简要总结
The aim of this study is to develop international consensus-based recommendations for tracheostomy care in critically ill patients. Using the Delphi method, the study seeks to identify key practices in post-tracheostomy management, including tube downsizing and decannulation strategies, infection prevention and site care, restoration of communication and swallowing, and the recognition and management of tracheostomy-related complications. By engaging a multidisciplinary panel of international experts involved in tracheostomy care, the study aims to reduce variability in current practice and support the development of standardized, evidence-informed approaches across different clinical settings.
详细描述
Background<br><br>
Tracheotomy is a common intervention in intensive care unit patients, with up to one in every six patients receiving a tracheostomy for weaning from invasive ventilation. Indications for tracheostomy include facilitating liberation from prolonged ventilation, protecting the airway, aiding secretion clearance, and enhancing patient comfort by supporting communication and swallowing.
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Variation in post-tracheotomy care often arises from the different clinical teams involved in tracheostomy care. Depending on local expertise and institutional organization, tracheostomies may be managed by otolaryngologists, intensivists, anesthesiologists, or general surgeons. Tracheostomy management encompasses an entire continuum of care, including decannulation strategies and infection prevention practices, as well as post-ICU follow-up and rehabilitation pathways.
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研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A minimum of 5 years of clinical experience treating patients requiring tracheostomy and leadership in the subject area.
- •At least 5 publications in the area.
排除标准
- •Not more than 70% of the panellists are of the same gender and from each of high and low-middle-income countries
结局指标
主要结局
Consensus on statements regarding tracheostomy care in critically ill patients
时间窗: through study completion, an average of 6-8 months
Consensus is defined as agreement over a pre-set benchmark of ≥75% agreement. If ≥75% of responses from all participants to a given statement indicate agreement (e.g., ratings in the upper categories of the 7-point Likert scale) in the final round of this Delphi study, consensus will be considered achieved and the statement will be retained as part of the final consensus recommendations on tracheostomy care.
次要结局
未报告次要终点
研究者
Denise Battaglini
Professor
Universita degli Studi di Genova