TRacheostomy in DElphi for iNTensive Care' (TRiDENT)

NCT07481435 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2026-05-04

No results posted yet for this study

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.

Conditions

  • Delphi Process
  • Delphi Study

Interventions

OTHER

Delphi Consensus Process

Round 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.

Sponsors & Collaborators

  • University of Michigan

    collaborator OTHER
  • The Royal Wolverhampton Hospitals NHS Trust

    collaborator OTHER_GOV
  • Hospital Israelita Albert Einstein

    collaborator OTHER
  • Amsterdam University of Applied Sciences

    collaborator OTHER
  • Tribhuvan University Teaching Hospital, Institute Of Medicine.

    collaborator OTHER
  • The University of Queensland

    collaborator OTHER
  • Federico II University

    collaborator OTHER
  • University of Birmingham

    collaborator OTHER
  • University of Oxford

    collaborator OTHER
  • University Wien

    collaborator OTHER
  • Monash University

    collaborator OTHER
  • Universita degli Studi di Genova

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2026-10-01
Completion
2026-12-01

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07481435 on ClinicalTrials.gov