TRacheostomy in DElphi for iNTensive Care' (TRiDENT)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 40
- Primary Endpoint
- Consensus on statements regarding tracheostomy care in critically ill patients
Study Overview
Brief Summary
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.
Detailed Description
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.
<br>
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.
<br><br>
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •Not more than 70% of the panellists are of the same gender and from each of high and low-middle-income countries
Outcomes
Primary Outcomes
Consensus on statements regarding tracheostomy care in critically ill patients
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Denise Battaglini
Professor
Universita degli Studi di Genova