TRacheostomy in DElphi for iNTensive Care' (TRiDENT)

NCT07481435 | Not Yet Recruiting

• 1 other identifier: TRiDENT
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Delphi Process; Delphi Study

Keywords

Intensive Care Medicine; Post Intensive Care

Outcome Measures

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.

  through study completion, an average of 6-8 months

Interventions

Delphi Consensus Process OTHER

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• Not more than 70% of the panellists are of the same gender and from each of high and low-middle-income countries

Sponsors & Collaborators

• 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
• Universita degli Studi di Genova: lead

Related Publications (30)

• 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: 37324074 RESULT

• 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: 38281994 RESULT

• 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: 34322364 RESULT

• 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: 15891345 RESULT

• 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: 39993868 RESULT

• 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: 38056485 RESULT

• 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: 41173643 RESULT

• 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: 36045040 RESULT

• 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: 36883211 RESULT

• 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: 28914429 RESULT

• 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: 35117562 RESULT

• 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: 25316527 RESULT

• 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: 28108683 RESULT

• 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: 20202948 RESULT

• 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: 28979454 RESULT

• 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: 26971032 RESULT

• 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: 32493580 RESULT

• 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: 32456776 RESULT

• 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: 38189928 RESULT

• 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: 35842715 RESULT

• 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: 28649385 RESULT

• 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: 41607852 RESULT

• 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: 39337948 RESULT

• 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: 33704354 RESULT

• 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: 31451858 RESULT

• 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.

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• 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.

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• 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.

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Central Study Contacts

Denise Battaglini, MD

CONTACT

+390105551; battaglini.denise@gmail.com

Marcus J Schultz, MD, PhD

CONTACT

marcus.j.schultz@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 13, 2026
• First Posted: March 18, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share