Delphi ProcessTRiDENTNCT07481435
TRacheostomy in DElphi for iNTensive Care' (TRiDENT)
An observational study of Delphi Process and Delphi Study, run by Universita degli Studi di Genova.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delphi Process, Delphi Study
- What is being tested?
- Delphi Consensus Process
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2026to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- 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.
Who cannot join
- Not more than 70% of the panellists are of the same gender and from each of high and low-middle-income countries
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Marcus J Schultz, MD, PhD contact
About this study
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.
Read the 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.
- Conditions
- Delphi Process, Delphi Study
- Being tested
- Delphi Consensus Process
- Keywords
- Intensive Care Medicine, Post Intensive Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delphi Consensus ProcessOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of 6-8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study start1 May 2026 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for Delphi ProcessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universita degli Studi di Genova
- Sponsor type
- University, hospital or other
- Collaborators
- University of Michigan, The Royal Wolverhampton Hospitals NHS Trust, Hospital Israelita Albert Einstein, Amsterdam University of Applied Sciences, Tribhuvan University Teaching Hospital, Institute Of Medicine., The University of Queensland, Federico II University, University of Birmingham, University of Oxford, University Wien, Monash University
- Responsible party
- Principal investigator, Denise Battaglini, Universita degli Studi di Genova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07481435
- Sponsor's protocol ID
- TRiDENT
- Acronym
- TRiDENT
- Status last verified
- Apr 2026
- First submitted
- 13 Mar 2026
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Anonymised reports of the Delphi rounds will be shared with original publication.
Publications
Pandian V, Atkins JH, Freeman-Sanderson A, Prush N, Feller-Kopman DJ, McGrath BA, Brenner MJ. Improving airway management and tracheostomy care through interprofessional collaboration: aligning timing, technique, and teamwork. J Thorac Dis. 2023 May 30;15(5):2363-2370. doi: 10.21037/jtd-23-205. Epub 2023 Apr 25. No abstract available.
PubMed 37324074Vargas M, Battaglini D, Antonelli M, Corso R, Frova G, Merli G, Petrini F, Ranieri MV, Sorbello M, Di Giacinto I, Terragni P, Brunetti I, Servillo G, Pelosi P. Follow-up short and long-term mortalities of tracheostomized critically ill patients in an Italian multi-center observational study. Sci Rep. 2024 Jan 28;14(1):2319. doi: 10.1038/s41598-024-52785-y.
PubMed 38281994Nasa P, Jain R, Juneja D. Delphi methodology in healthcare research: How to decide its appropriateness. World J Methodol. 2021 Jul 20;11(4):116-129. doi: 10.5662/wjm.v11.i4.116. eCollection 2021 Jul 20.
PubMed 34322364Gregoretti C, Olivieri C, Navalesi P. Physiologic comparison between conventional mechanical ventilation and transtracheal open ventilation in acute traumatic quadriplegic patients. Crit Care Med. 2005 May;33(5):1114-8. doi: 10.1097/01.ccm.0000162559.74446.09.
PubMed 15891345Stone TS, Miller CL, Summey J, Bongiovanni R, Nemecek E, Merlin MA. Humidification and Tracheostomy Care in Transit: A Systematic Review of Current Evidence and Future Directions. Air Med J. 2025 Jan-Feb;44(1):99-104. doi: 10.1016/j.amj.2024.10.006. Epub 2024 Dec 5.
PubMed 39993868Gajic S, Jacobs L, Gellentien C, Dubin RM, Ma K. Implementation of Above-Cuff Vocalization After Tracheostomy Is Feasible and Associated With Earlier Speech. Am J Speech Lang Pathol. 2024 Jan 3;33(1):51-56. doi: 10.1044/2023_AJSLP-23-00184. Epub 2023 Dec 6.
PubMed 38056485Lemyze M, Lecorche M, Laouki CE, Granier M, Mallat J. Toleration of a Speaking Valve Placed In-Line With the Ventilator Circuit in Critically Ill Tracheostomized Patients. Am J Crit Care. 2025 Nov 1;34(6):e59-e64. doi: 10.4037/ajcc2025258.
PubMed 41173643Sutt AL, Cornwell PL, Hay K, Fraser JF, Rose L. Communication Success and Speaking Valve Use in Intensive Care Patients Receiving Mechanical Ventilation. Am J Crit Care. 2022 Sep 1;31(5):411-415. doi: 10.4037/ajcc2022516.
PubMed 36045040Mc Mahon A, Griffin S, Gorman E, Lennon A, Kielthy S, Flannery A, Cherian BS, Josy M, Marsh B. Patient-Centred Outcomes Following Tracheostomy in Critical Care. J Intensive Care Med. 2023 Aug;38(8):727-736. doi: 10.1177/08850666231160669. Epub 2023 Mar 7.
PubMed 36883211Nakarada-Kordic I, Patterson N, Wrapson J, Reay SD. A Systematic Review of Patient and Caregiver Experiences with a Tracheostomy. Patient. 2018 Apr;11(2):175-191. doi: 10.1007/s40271-017-0277-1.
PubMed 28914429Bibas BJ, Cardoso PFG, Hoetzenecker K. The burden of tracheal stenosis and tracheal diseases health-care costs in the 21st century. Transl Cancer Res. 2020 Mar;9(3):2095-2096. doi: 10.21037/tcr.2020.02.59. No abstract available.
PubMed 35117562McWilliams D, Weblin J, Atkins G, Bion J, Williams J, Elliott C, Whitehouse T, Snelson C. Enhancing rehabilitation of mechanically ventilated patients in the intensive care unit: a quality improvement project. J Crit Care. 2015 Feb;30(1):13-8. doi: 10.1016/j.jcrc.2014.09.018. Epub 2014 Oct 2.
PubMed 25316527Mah JW, Staff II, Fisher SR, Butler KL. Improving Decannulation and Swallowing Function: A Comprehensive, Multidisciplinary Approach to Post-Tracheostomy Care. Respir Care. 2017 Feb;62(2):137-143. doi: 10.4187/respcare.04878. Epub 2016 Nov 15.
PubMed 28108683Skoretz SA, Flowers HL, Martino R. The incidence of dysphagia following endotracheal intubation: a systematic review. Chest. 2010 Mar;137(3):665-73. doi: 10.1378/chest.09-1823.
PubMed 20202948McGrath B, Lynch J, Wilson M, Nicholson L, Wallace S. Above cuff vocalisation: A novel technique for communication in the ventilator-dependent tracheostomy patient. J Intensive Care Soc. 2016 Feb;17(1):19-26. doi: 10.1177/1751143715607549. Epub 2015 Oct 5.
PubMed 28979454
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TRacheostomy in DElphi for iNTensive Care' (TRiDENT)
- ClinicalTrials.gov ID
- NCT07481435
- Acronym / sponsor ID
- TRiDENT / TRiDENT
- Conditions
- Delphi Process, Delphi Study
- Keywords
- Intensive Care Medicine, Post Intensive Care
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Universita degli Studi di GenovaUniversity, hospital or other
- Collaborators
- University of Michigan, The Royal Wolverhampton Hospitals NHS Trust, Hospital Israelita Albert Einstein, Amsterdam University of Applied Sciences, Tribhuvan University Teaching Hospital, Institute Of Medicine., The University of Queensland, Federico II University, University of Birmingham, University of Oxford, University Wien, Monash University
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 18 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Not more than 70% of the panellists are of the same gender and from each of high and low-middle-income countries
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Delphi Consensus ProcessRound 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. | Other | – |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Results publication: PubMed 37324074Pandian V, Atkins JH, Freeman-Sanderson A, Prush N, Feller-Kopman DJ, McGrath BA, Brenner MJ. Improving airway management and tracheostomy care through interprofessional collaboration: aligning timing, technique, and teamwork. J Thorac Dis. 2023 May 30;15(5):2363-2370. doi: 10.21037/jtd-23-205. Epub 2023 Apr 25. No abstract available.
- Results publication: PubMed 38281994Vargas M, Battaglini D, Antonelli M, Corso R, Frova G, Merli G, Petrini F, Ranieri MV, Sorbello M, Di Giacinto I, Terragni P, Brunetti I, Servillo G, Pelosi P. Follow-up short and long-term mortalities of tracheostomized critically ill patients in an Italian multi-center observational study. Sci Rep. 2024 Jan 28;14(1):2319. doi: 10.1038/s41598-024-52785-y.
- Results publication: PubMed 34322364Nasa P, Jain R, Juneja D. Delphi methodology in healthcare research: How to decide its appropriateness. World J Methodol. 2021 Jul 20;11(4):116-129. doi: 10.5662/wjm.v11.i4.116. eCollection 2021 Jul 20.
- Results publication: PubMed 15891345Gregoretti C, Olivieri C, Navalesi P. Physiologic comparison between conventional mechanical ventilation and transtracheal open ventilation in acute traumatic quadriplegic patients. Crit Care Med. 2005 May;33(5):1114-8. doi: 10.1097/01.ccm.0000162559.74446.09.
- Results publication: PubMed 39993868Stone TS, Miller CL, Summey J, Bongiovanni R, Nemecek E, Merlin MA. Humidification and Tracheostomy Care in Transit: A Systematic Review of Current Evidence and Future Directions. Air Med J. 2025 Jan-Feb;44(1):99-104. doi: 10.1016/j.amj.2024.10.006. Epub 2024 Dec 5.
- Results publication: PubMed 38056485Gajic S, Jacobs L, Gellentien C, Dubin RM, Ma K. Implementation of Above-Cuff Vocalization After Tracheostomy Is Feasible and Associated With Earlier Speech. Am J Speech Lang Pathol. 2024 Jan 3;33(1):51-56. doi: 10.1044/2023_AJSLP-23-00184. Epub 2023 Dec 6.
- Results publication: PubMed 41173643Lemyze M, Lecorche M, Laouki CE, Granier M, Mallat J. Toleration of a Speaking Valve Placed In-Line With the Ventilator Circuit in Critically Ill Tracheostomized Patients. Am J Crit Care. 2025 Nov 1;34(6):e59-e64. doi: 10.4037/ajcc2025258.
- Results publication: PubMed 36045040Sutt AL, Cornwell PL, Hay K, Fraser JF, Rose L. Communication Success and Speaking Valve Use in Intensive Care Patients Receiving Mechanical Ventilation. Am J Crit Care. 2022 Sep 1;31(5):411-415. doi: 10.4037/ajcc2022516.
- Results publication: PubMed 36883211Mc Mahon A, Griffin S, Gorman E, Lennon A, Kielthy S, Flannery A, Cherian BS, Josy M, Marsh B. Patient-Centred Outcomes Following Tracheostomy in Critical Care. J Intensive Care Med. 2023 Aug;38(8):727-736. doi: 10.1177/08850666231160669. Epub 2023 Mar 7.
- Results publication: PubMed 28914429Nakarada-Kordic I, Patterson N, Wrapson J, Reay SD. A Systematic Review of Patient and Caregiver Experiences with a Tracheostomy. Patient. 2018 Apr;11(2):175-191. doi: 10.1007/s40271-017-0277-1.
- Results publication: PubMed 35117562Bibas BJ, Cardoso PFG, Hoetzenecker K. The burden of tracheal stenosis and tracheal diseases health-care costs in the 21st century. Transl Cancer Res. 2020 Mar;9(3):2095-2096. doi: 10.21037/tcr.2020.02.59. No abstract available.
- Results publication: PubMed 25316527McWilliams D, Weblin J, Atkins G, Bion J, Williams J, Elliott C, Whitehouse T, Snelson C. Enhancing rehabilitation of mechanically ventilated patients in the intensive care unit: a quality improvement project. J Crit Care. 2015 Feb;30(1):13-8. doi: 10.1016/j.jcrc.2014.09.018. Epub 2014 Oct 2.
- Individual participant dataSharing planned: No. Anonymised reports of the Delphi rounds will be shared with original publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marcus J Schultz, MD, PhD contact
Questions about this trial
What is this clinical trial studying?
An observational study of Delphi Process and Delphi Study, run by Universita degli Studi di Genova.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Denise Battaglini, MD (+390105551, battaglini.denise@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Consensus on statements regarding tracheostomy care in critically ill patients (time frame: through study completion, an average of 6-8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07481435, which also lists 30 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.