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:
Organization:
Raw JSON
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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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Intensive Care Medicine', 'Post Intensive Care'], 'conditions': ['Delphi Process', 'Delphi Study']}, 'referencesModule': {'references': [{'pmid': '37324074', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '38281994', 'type': 'RESULT', 'citation': 'Vargas 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.'}, {'pmid': '34322364', 'type': 'RESULT', 'citation': 'Nasa 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.'}, {'pmid': '15891345', 'type': 'RESULT', 'citation': 'Gregoretti 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.'}, {'pmid': '39993868', 'type': 'RESULT', 'citation': 'Stone 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.'}, {'pmid': '38056485', 'type': 'RESULT', 'citation': 'Gajic 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.'}, {'pmid': '41173643', 'type': 'RESULT', 'citation': 'Lemyze 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.'}, {'pmid': '36045040', 'type': 'RESULT', 'citation': 'Sutt 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.'}, {'pmid': '36883211', 'type': 'RESULT', 'citation': 'Mc 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.'}, {'pmid': '28914429', 'type': 'RESULT', 'citation': 'Nakarada-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.'}, {'pmid': '35117562', 'type': 'RESULT', 'citation': 'Bibas 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.'}, {'pmid': '25316527', 'type': 'RESULT', 'citation': 'McWilliams 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.'}, {'pmid': '28108683', 'type': 'RESULT', 'citation': 'Mah 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.'}, {'pmid': '20202948', 'type': 'RESULT', 'citation': 'Skoretz 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.'}, {'pmid': '28979454', 'type': 'RESULT', 'citation': 'McGrath 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.'}, {'pmid': '26971032', 'type': 'RESULT', 'citation': 'Freeman-Sanderson AL, Togher L, Elkins MR, Phipps PR. Quality of life improves with return of voice in tracheostomy patients in intensive care: An observational study. J Crit Care. 2016 Jun;33:186-91. doi: 10.1016/j.jcrc.2016.01.012. Epub 2016 Jan 13.'}, {'pmid': '32493580', 'type': 'RESULT', 'citation': 'McGrath BA, Wallace S, Lynch J, Bonvento B, Coe B, Owen A, Firn M, Brenner MJ, Edwards E, Finch TL, Cameron T, Narula A, Roberson DW. Improving tracheostomy care in the United Kingdom: results of a guided quality improvement programme in 20 diverse hospitals. Br J Anaesth. 2020 Jul;125(1):e119-e129. doi: 10.1016/j.bja.2020.04.064. Epub 2020 May 31.'}, {'pmid': '32456776', 'type': 'RESULT', 'citation': 'Brenner MJ, Pandian V, Milliren CE, Graham DA, Zaga C, Morris LL, Bedwell JR, Das P, Zhu H, Lee Y Allen J, Peltz A, Chin K, Schiff BA, Randall DM, Swords C, French D, Ward E, Sweeney JM, Warrillow SJ, Arora A, Narula A, McGrath BA, Cameron TS, Roberson DW. Global Tracheostomy Collaborative: data-driven improvements in patient safety through multidisciplinary teamwork, standardisation, education, and patient partnership. Br J Anaesth. 2020 Jul;125(1):e104-e118. doi: 10.1016/j.bja.2020.04.054. Epub 2020 May 23.'}, {'pmid': '38189928', 'type': 'RESULT', 'citation': 'Gallice T, Cugy E, Branchard O, Dehail P, Moucheboeuf G. Predictive Factors for Successful Decannulation in Patients with Tracheostomies and Brain Injuries: A Systematic Review. Dysphagia. 2024 Aug;39(4):552-572. doi: 10.1007/s00455-023-10646-2. Epub 2024 Jan 8.'}, {'pmid': '35842715', 'type': 'RESULT', 'citation': 'Zhou T, Wang J, Zhang C, Zhang B, Guo H, Yang B, Li Q, Ge J, Li Y, Niu G, Gao H, Jiang H. Tracheostomy decannulation protocol in patients with prolonged tracheostomy referred to a rehabilitation hospital: a prospective cohort study. J Intensive Care. 2022 Jul 16;10(1):34. doi: 10.1186/s40560-022-00626-3.'}, {'pmid': '28649385', 'type': 'RESULT', 'citation': 'Singh RK, Saran S, Baronia AK. The practice of tracheostomy decannulation-a systematic review. J Intensive Care. 2017 Jun 20;5:38. doi: 10.1186/s40560-017-0234-z. eCollection 2017.'}, {'pmid': '41607852', 'type': 'RESULT', 'citation': 'Brenner MJ, Sahay S, Silveira RM, Moser C, Morrison ME, Zeitler NK, Yang CJ, Colandrea M, McElroy K, Pandian V. Addressing Education and Care Gaps in Tracheostomy Management: Insights from a Multi-Stakeholder Global Survey. Tracheostomy. 2025 Mar 31;2(1):15-28. doi: 10.62905/001c.129226.'}, {'pmid': '39337948', 'type': 'RESULT', 'citation': 'Merola R, Iacovazzo C, Troise S, Marra A, Formichella A, Servillo G, Vargas M. Timing of Tracheostomy in ICU Patients: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Life (Basel). 2024 Sep 14;14(9):1165. doi: 10.3390/life14091165.'}, {'pmid': '33704354', 'type': 'RESULT', 'citation': 'Chorath K, Hoang A, Rajasekaran K, Moreira A. Association of Early vs Late Tracheostomy Placement With Pneumonia and Ventilator Days in Critically Ill Patients: A Meta-analysis. JAMA Otolaryngol Head Neck Surg. 2021 May 1;147(5):450-459. doi: 10.1001/jamaoto.2021.0025.'}, {'pmid': '31451858', 'type': 'RESULT', 'citation': "Aquino Esperanza J, Pelosi P, Blanch L. What's new in intensive care: tracheostomy-what is known and what remains to be determined. Intensive Care Med. 2019 Nov;45(11):1619-1621. doi: 10.1007/s00134-019-05758-z. Epub 2019 Aug 26. No abstract available."}, {'pmid': '36693401', 'type': 'RESULT', 'citation': 'Pham T, Heunks L, Bellani G, Madotto F, Aragao I, Beduneau G, Goligher EC, Grasselli G, Laake JH, Mancebo J, Penuelas O, Piquilloud L, Pesenti A, Wunsch H, van Haren F, Brochard L, Laffey JG; WEAN SAFE Investigators. Weaning from mechanical ventilation in intensive care units across 50 countries (WEAN SAFE): a multicentre, prospective, observational cohort study. Lancet Respir Med. 2023 May;11(5):465-476. doi: 10.1016/S2213-2600(22)00449-0. Epub 2023 Jan 21.'}, {'pmid': '9445274', 'type': 'RESULT', 'citation': 'Straus C, Louis B, Isabey D, Lemaire F, Harf A, Brochard L. Contribution of the endotracheal tube and the upper airway to breathing workload. Am J Respir Crit Care Med. 1998 Jan;157(1):23-30. doi: 10.1164/ajrccm.157.1.96-10057.'}, {'pmid': '10507588', 'type': 'RESULT', 'citation': 'Kollef MH, Ahrens TS, Shannon W. Clinical predictors and outcomes for patients requiring tracheostomy in the intensive care unit. Crit Care Med. 1999 Sep;27(9):1714-20. doi: 10.1097/00003246-199909000-00003.'}, {'pmid': '15699830', 'type': 'RESULT', 'citation': "Frutos-Vivar F, Esteban A, Apezteguia C, Anzueto A, Nightingale P, Gonzalez M, Soto L, Rodrigo C, Raad J, David CM, Matamis D, D' Empaire G; International Mechanical Ventilation Study Group. Outcome of mechanically ventilated patients who require a tracheostomy. Crit Care Med. 2005 Feb;33(2):290-8. doi: 10.1097/01.ccm.0000150026.85210.13."}, {'pmid': '30115127', 'type': 'RESULT', 'citation': 'Abe T, Madotto F, Pham T, Nagata I, Uchida M, Tamiya N, Kurahashi K, Bellani G, Laffey JG; LUNG-SAFE Investigators and the ESICM Trials Group. Epidemiology and patterns of tracheostomy practice in patients with acute respiratory distress syndrome in ICUs across 50 countries. Crit Care. 2018 Aug 17;22(1):195. doi: 10.1186/s13054-018-2126-6.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Background\\<br\\>\\<br\\>\n\nTracheotomy 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.\n\n\\<br\\>\n\nVariation 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.\n\n\\<br\\>\\<br\\>\n\nTracheostomy 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.\n\n\\<br\\>\\<br\\>\n\nThese 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.\n\n\\<br\\>\\<br\\>\n\nAddressing 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.\n\n\\<br\\>\\<br\\>\n\nStudy Design\\<br\\>\\<br\\>\n\nThe 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.\n\n\\<br\\>\\<br\\>\n\nA 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.\n\n\\<br\\>\\<br\\>\n\nThe 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.\n\n\\<br\\>\\<br\\>\n\nA 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.\n\n\\<br\\>\\<br\\>\n\nPotential 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.\n\nEach Delphi round will last approximately two weeks.\n\n\\<br\\>\\<br\\>\n\nStep 1: Establishing Preliminary Domains\\<br\\>\\<br\\>\n\nDomain 1: Cannula care\\<br\\> Domain 2: Complication management\\<br\\> Domain 3: Care trajectories\\<br\\>\\<br\\>\\<br\\>\n\nStep 2: Preparation of the Delphi Round 1 Survey\\<br\\>\\<br\\>\n\nPanelists 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.\n\n\\<br\\> Responses and comments will be compiled into a report providing controlled feedback for subsequent rounds.\\<br\\>\\<br\\>\n\nStep 3: Subsequent Delphi Rounds\\<br\\>\\<br\\>\n\nThe 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.\n\n\\<br\\> Consensus will be defined as ≥75% agreement or disagreement on Likert scale responses and multiple-choice questions.\\<br\\>\\<br\\>\n\nStep 4: Final Consensus\\<br\\>\\<br\\>\n\nResults from the final stable round will be used to draft consensus-based statements regarding tracheostomy management.\\<br\\>\\<br\\>\n\nPatient and Public Involvement\\<br\\>\\<br\\>\n\nPatient 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\\>\n\nEconomic Considerations\\<br\\>\\<br\\>\n\nHealthcare 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A minimum of 5 years of clinical experience treating patients requiring tracheostomy and leadership in the subject area.\n* At least 5 publications in the area.\n\nExclusion Criteria:\n\n* Not more than 70% of the panellists are of the same gender and from each of high and low-middle-income countries'}, 'identificationModule': {'nctId': 'NCT07481435', 'acronym': 'TRiDENT', 'briefTitle': "TRacheostomy in DElphi for iNTensive Care' (TRiDENT)", 'organization': {'class': 'OTHER', 'fullName': 'Universita degli Studi di Genova'}, 'officialTitle': "TRacheostomy in DElphi for iNTensive Care' (TRiDENT)", 'orgStudyIdInfo': {'id': 'TRiDENT'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Delphi Consensus Process', 'type': 'OTHER', 'description': 'Round 1: Evaluation and rating of preliminary statements on tracheostomy care derived from literature review and expert input.\n\nRound 2: Re-rating of statements from Round 1 with controlled feedback and modification based on panelist comments.\n\nRound 3: Final consensus assessment on remaining statements that did not reach agreement in previous rounds.\n\nRound 4: Prioritization and refinement of the final consensus statements to define key recommendations and research priorities in tracheostomy care.'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Denise Battaglini, MD', 'role': 'CONTACT', 'email': 'battaglini.denise@gmail.com', 'phone': '+390105551'}, {'name': 'Marcus J Schultz, MD, PhD', 'role': 'CONTACT', 'email': 'marcus.j.schultz@gmail.com'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Anonymised reports of the Delphi rounds will be shared with original publication.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universita degli Studi di Genova', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Michigan', 'class': 'OTHER'}, {'name': 'The Royal Wolverhampton Hospitals NHS Trust', 'class': 'OTHER_GOV'}, {'name': 'Hospital Israelita Albert Einstein', 'class': 'OTHER'}, {'name': 'Amsterdam University of Applied Sciences', 'class': 'OTHER'}, {'name': 'Tribhuvan University Teaching Hospital, Institute Of Medicine.', 'class': 'OTHER'}, {'name': 'The University of Queensland', 'class': 'OTHER'}, {'name': 'Federico II University', 'class': 'OTHER'}, {'name': 'University of Birmingham', 'class': 'OTHER'}, {'name': 'University of Oxford', 'class': 'OTHER'}, {'name': 'University Wien', 'class': 'OTHER'}, {'name': 'Monash University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Denise Battaglini', 'investigatorAffiliation': 'Universita degli Studi di Genova'}}}}