Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 9:23 AM
Study NCT ID:
NCT07481435
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-18
First Post:
2026-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TRacheostomy in DElphi for iNTensive Care' (TRiDENT)
Sponsor:
Universita degli Studi di Genova
Organization:
Study Overview
Official Title:
TRacheostomy in DElphi for iNTensive Care' (TRiDENT)
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TRiDENT
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\>
Tracheostomy care lacks standardization, particularly regarding tube downsizing and safe decannulation, infection prevention and tracheostomy site care, and strategies to restore communication, swallowing, and feeding. In addition, timely recognition and management of complications beyond the peri-tracheotomy phase (e.g., posterior glottic stenosis, tracheal stenosis, granuloma formation, airway patency issues), as well as minimum requirements for post-ICU tracheostomy care, are often poorly defined.
\<br\>\<br\>
These gaps may lead to clinically relevant consequences, including cannula obstruction or dislodgement, delayed decannulation, airway complications, impaired communication, swallowing dysfunction, psychological distress, and increased caregiver burden.
\<br\>\<br\>
Addressing these domains through expert consensus is crucial to improving patient recovery and quality of life, reducing complications, and ensuring equitable standards of tracheostomy care across different settings. We therefore designed a Delphi study named "TRacheostomy in DEiphi for iNTensive care' (TRiDENT)" to gather and synthesize international multidisciplinary expertise to establish consensus and identify research priorities in tracheostomy care.
\<br\>\<br\>
Study Design\<br\>\<br\>
The TRiDEnt study will utilize a Delphi methodology to achieve consensus or identify areas of disagreement regarding tracheostomy management in intensive care. Reporting of the Delphi process will adhere to the ACcurate COnsensus Reporting Document (ACCORD) guidelines.
\<br\>\<br\>
A Steering Committee composed of experienced physicians and researchers in tracheostomy and critical care will lead the study. Two members of the Steering Committee will serve as Delphi methodologists. The Steering Committee will perform a focused literature review on post-tracheostomy care in the critical care setting to inform the questions of the initial Delphi round.
\<br\>\<br\>
The committee will identify and select panelists from global institutions based on predefined eligibility criteria. To facilitate consensus among panelists, the Steering Committee will conduct iterative Delphi rounds, prepare round reports, and modify or add statements based on panelist feedback. Statements reaching consensus and stability will be used to develop clinical practice statements. Steering Committee members will not participate as respondents in the Delphi surveys.
\<br\>\<br\>
A diverse panel of approximately 35-40 experts will be recruited from multiple disciplines involved in tracheostomy care, including otolaryngology and maxillofacial surgery, intensive care medicine, respiratory medicine, anesthesiology, nursing, respiratory therapy, speech and language therapy, physiotherapy, and physiatry. Panelists will be selected using purposive sampling based on expertise and recent publications in the field.
\<br\>\<br\>
Potential participants will be invited via email and informed about the study objectives and the Delphi process. Communication will be maintained throughout the study to encourage retention, with reminders sent during each round.
Each Delphi round will last approximately two weeks.
\<br\>\<br\>
Step 1: Establishing Preliminary Domains\<br\>\<br\>
Domain 1: Cannula care\<br\> Domain 2: Complication management\<br\> Domain 3: Care trajectories\<br\>\<br\>\<br\>
Step 2: Preparation of the Delphi Round 1 Survey\<br\>\<br\>
Panelists will receive an online survey containing questions related to the identified domains. Responses will be anonymized to ensure confidentiality and minimize peer pressure and conformity bias. Participants will answer based on their expertise using multiple-choice questions and a 7-point Likert scale.
\<br\> Responses and comments will be compiled into a report providing controlled feedback for subsequent rounds.\<br\>\<br\>
Step 3: Subsequent Delphi Rounds\<br\>\<br\>
The Steering Committee will review the results from each round and modify, remove, or add statements based on feedback. Updated statements will be presented in subsequent rounds until stable consensus or dissensus is achieved.
\<br\> Consensus will be defined as ≥75% agreement or disagreement on Likert scale responses and multiple-choice questions.\<br\>\<br\>
Step 4: Final Consensus\<br\>\<br\>
Results from the final stable round will be used to draft consensus-based statements regarding tracheostomy management.\<br\>\<br\>
Patient and Public Involvement\<br\>\<br\>
Patient and public involvement is planned to ensure that consensus outcomes reflect not only clinical priorities but also the experiences of individuals living with a tracheostomy and their families.\<br\>\<br\>
Economic Considerations\<br\>\<br\>
Healthcare economists will contribute to the evaluation of the cost-effectiveness and resource implications of proposed practices, given the substantial economic burden associated with tracheostomy care.
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\>
Tracheostomy care lacks standardization, particularly regarding tube downsizing and safe decannulation, infection prevention and tracheostomy site care, and strategies to restore communication, swallowing, and feeding. In addition, timely recognition and management of complications beyond the peri-tracheotomy phase (e.g., posterior glottic stenosis, tracheal stenosis, granuloma formation, airway patency issues), as well as minimum requirements for post-ICU tracheostomy care, are often poorly defined.
\<br\>\<br\>
These gaps may lead to clinically relevant consequences, including cannula obstruction or dislodgement, delayed decannulation, airway complications, impaired communication, swallowing dysfunction, psychological distress, and increased caregiver burden.
\<br\>\<br\>
Addressing these domains through expert consensus is crucial to improving patient recovery and quality of life, reducing complications, and ensuring equitable standards of tracheostomy care across different settings. We therefore designed a Delphi study named "TRacheostomy in DEiphi for iNTensive care' (TRiDENT)" to gather and synthesize international multidisciplinary expertise to establish consensus and identify research priorities in tracheostomy care.
\<br\>\<br\>
Study Design\<br\>\<br\>
The TRiDEnt study will utilize a Delphi methodology to achieve consensus or identify areas of disagreement regarding tracheostomy management in intensive care. Reporting of the Delphi process will adhere to the ACcurate COnsensus Reporting Document (ACCORD) guidelines.
\<br\>\<br\>
A Steering Committee composed of experienced physicians and researchers in tracheostomy and critical care will lead the study. Two members of the Steering Committee will serve as Delphi methodologists. The Steering Committee will perform a focused literature review on post-tracheostomy care in the critical care setting to inform the questions of the initial Delphi round.
\<br\>\<br\>
The committee will identify and select panelists from global institutions based on predefined eligibility criteria. To facilitate consensus among panelists, the Steering Committee will conduct iterative Delphi rounds, prepare round reports, and modify or add statements based on panelist feedback. Statements reaching consensus and stability will be used to develop clinical practice statements. Steering Committee members will not participate as respondents in the Delphi surveys.
\<br\>\<br\>
A diverse panel of approximately 35-40 experts will be recruited from multiple disciplines involved in tracheostomy care, including otolaryngology and maxillofacial surgery, intensive care medicine, respiratory medicine, anesthesiology, nursing, respiratory therapy, speech and language therapy, physiotherapy, and physiatry. Panelists will be selected using purposive sampling based on expertise and recent publications in the field.
\<br\>\<br\>
Potential participants will be invited via email and informed about the study objectives and the Delphi process. Communication will be maintained throughout the study to encourage retention, with reminders sent during each round.
Each Delphi round will last approximately two weeks.
\<br\>\<br\>
Step 1: Establishing Preliminary Domains\<br\>\<br\>
Domain 1: Cannula care\<br\> Domain 2: Complication management\<br\> Domain 3: Care trajectories\<br\>\<br\>\<br\>
Step 2: Preparation of the Delphi Round 1 Survey\<br\>\<br\>
Panelists will receive an online survey containing questions related to the identified domains. Responses will be anonymized to ensure confidentiality and minimize peer pressure and conformity bias. Participants will answer based on their expertise using multiple-choice questions and a 7-point Likert scale.
\<br\> Responses and comments will be compiled into a report providing controlled feedback for subsequent rounds.\<br\>\<br\>
Step 3: Subsequent Delphi Rounds\<br\>\<br\>
The Steering Committee will review the results from each round and modify, remove, or add statements based on feedback. Updated statements will be presented in subsequent rounds until stable consensus or dissensus is achieved.
\<br\> Consensus will be defined as ≥75% agreement or disagreement on Likert scale responses and multiple-choice questions.\<br\>\<br\>
Step 4: Final Consensus\<br\>\<br\>
Results from the final stable round will be used to draft consensus-based statements regarding tracheostomy management.\<br\>\<br\>
Patient and Public Involvement\<br\>\<br\>
Patient and public involvement is planned to ensure that consensus outcomes reflect not only clinical priorities but also the experiences of individuals living with a tracheostomy and their families.\<br\>\<br\>
Economic Considerations\<br\>\<br\>
Healthcare economists will contribute to the evaluation of the cost-effectiveness and resource implications of proposed practices, given the substantial economic burden associated with tracheostomy care.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: