TRacheostomy in DElphi for iNTensive Care' (TRiDENT)
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversita degli Studi di Genova
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Not more than 70% of the panellists are of the same gender and from each of high and low-middle-income countries
Trial population
A diverse panel of 35-40 experts will be recruited from various professional disciplines, including ear nose and throat (ENT) and/or Maxillofacial Surgery, Intensive Care Medicine, Respiratory Medicine, Anesthesiology, Nursing, Respiratory Therapists, Speech and Language Therapists, Physiotherapists, and Physiatrists with a substantial experience in the field of tracheostomy care.
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Delphi Consensus Process
Other interventionRound 1: Evaluation and rating of preliminary statements on tracheostomy care derived from literature review and expert input. Round 2: Re-rating of statements from Round 1 with controlled feedback and modification based on panelist comments. Round 3: Final consensus assessment on remaining statements that did not reach agreement in previous rounds. Round 4: Prioritization and refinement of the final consensus statements to define key recommendations and research priorities in tracheostomy care.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Consensus on statements regarding tracheostomy care in critically ill patients
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.
Time frame
through study completion, an average of 6-8 monthsLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Universita degli Studi di Genova
Lead sponsor
University of Michigan
Collaborator
The Royal Wolverhampton Hospitals NHS Trust
Collaborator
Hospital Israelita Albert Einstein
Collaborator
Amsterdam University of Applied Sciences
Collaborator
Tribhuvan University Teaching Hospital, Institute Of Medicine.
Collaborator
The University of Queensland
Collaborator
Federico II University
Collaborator
University of Birmingham
Collaborator
University of Oxford
Collaborator
University Wien
Collaborator
Monash University
Collaborator
Source ClinicalTrials.gov
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