Tracheostomy Practice in Adult Intensive Care Units

Care of the patient with a tracheostomy is a core element of critical care practice. Around 20% of patients admitted to an intensive care unit (ICU) undergo tracheostomy insertion during their stay, typically in the context of prolonged mechanical ventilation and complex rehabilitation needs. Despite its frequent use and ongoing quality improvement initiatives, considerable variation in practice continues to exist and many questions with regards to tracheostomy timing, insertion, management and longer-term outcomes remain.

Variation exists not only because of patient characteristics, but also from an organisational perspective with diversity in hospital settings, system demands and governance structures. These inconsistencies lead to deficiencies in care and avoidable harm, increased morbidity and mortality.

This is an international multicentre prospective observational study to comprehensively characterise current tracheostomy practice. The study aims to describe the indications, timing, techniques, and management of tracheostomy insertion and care; to evaluate patient-centred outcomes and procedure-related adverse events; and to explore the organisational structures and models of care supporting tracheostomised patients in the ICU and beyond. This will allow us to identify variation in care, it's origin, drive improvement and enhance safety and outcomes for patients with a tracheostomy in the future.

Primary outcomes

• Successful tracheostomy decannulation [90 days]: The proportion of patients successfully decannulated from tracheostomy, censored at hospital discharge or 90 days, whichever comes first.

Secondary outcomes

• Time to decannulation [90 days]: Time to successful decannulation censored at hospital discharge or 90 days, whichever comes first.
• Mortality [90 days]
• Hospital utilization metrics [90 days]: Duration of mechanical ventilation, ICU and hospital length of stay
• Return to vocalisation [90 days]: Measured by time in days to placement of a speaking valve
• Return to oral intake [90 days]: Measured using the Functional Oral Intake Scale (FOIS) which ranges from level 1 to 7, where level 1 is no oral intake and level 7 is full oral intake with no restrictions.
• Return to mobilisation [90 days]: Measured using the Intensive Care Mobility Scale which ranges from 1 to 10 with 10 indicating a greater degree of mobility.
• Health related quality of life [3, 6 and 12 months]: Quality of life measured using the EuroQol five-dimensional questionnaire (EQ-5D-5L) with a lower score indicating a better quality of life.

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Greater than 18 years of age
* Tracheostomy insertion during critical care admission

Exclusion Criteria:

* Tracheostomy prior to critical care admission
* Elective tracheostomy insertion for head and neck pathology
* Tracheostomy insertion for emergency surgical management of airway obstruction
* Mini tracheostomy insertion only

• 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. PMID 30115127
• Premraj L, Camarda C, White N, Godoy DA, Cuthbertson BH, Rocco PRM, Pelosi P, Robba C, Suarez JI, Cho SM, Battaglini D. Tracheostomy timing and outcome in critically ill patients with stroke: a meta-analysis and meta-regression. Crit Care. 2023 Apr 1;27(1):132. doi: 10.1186/s13054-023-04417-6. PMID 37005666
• Selekwa M, Maina I, Yeh T, Nkya A, Ncogoza I, Nuss RC, Mushi BP, Haddadi S, Van Loon K, Mbaga E, Massawe W, Roberson DW, Dharsee N, Musimu B, Xu MJ. Tracheostomy care quality improvement in low- and middle-income countries: A scoping review. PLOS Glob Public Health. 2023 Nov 9;3(11):e0002294. doi: 10.1371/journal.pgph.0002294. eCollection 2023. PMID 37943736
• Vargas M, Sutherasan Y, Antonelli M, Brunetti I, Corcione A, Laffey JG, Putensen C, Servillo G, Pelosi P. Tracheostomy procedures in the intensive care unit: an international survey. Crit Care. 2015 Aug 13;19(1):291. doi: 10.1186/s13054-015-1013-7. PMID 26271742
• Merola R, Vargas M, Sanfilippo F, Vergano M, Mistraletti G, Vetrugno L, De Pascale G, Bignami EG, Servillo G, Battaglini D. Tracheostomy Practice in the Italian Intensive Care Units: A Point-Prevalence Survey. Medicina (Kaunas). 2025 Jan 7;61(1):87. doi: 10.3390/medicina61010087. PMID 39859070
• Polok K, Fronczek J, van Heerden PV, Flaatten H, Guidet B, De Lange DW, Fjolner J, Leaver S, Beil M, Sviri S, Bruno RR, Wernly B, Artigas A, Pinto BB, Schefold JC, Studzinska D, Joannidis M, Oeyen S, Marsh B, Andersen FH, Moreno R, Cecconi M, Jung C, Szczeklik W; COVIP study group. Association between tracheostomy timing and outcomes for older critically ill COVID-19 patients: prospective observational study in European intensive care units. Br J Anaesth. 2022 Mar;128(3):482-490. doi: 10.1016/j.bja.2021.11.027. Epub 2021 Nov 29. PMID 34955167
• Zaga CJ, Milliren CE, McGrath BA, Yang CJ, Schiff BA, Warrillow SJ, Henningfeld JK, Gregson PA, Bedwell JR, Beaudet KM, Brenner MJ, Pandian V. Predictors of Decannulation Success in Tracheostomy: A 10-Year Analysis of the Global Tracheostomy Collaborative Database. Otolaryngol Head Neck Surg. 2025 Nov;173(5):1138-1148. doi: 10.1002/ohn.70013. Epub 2025 Sep 2. PMID 40891658
• Carton E, Fitzgerald E, Elebert R, Malone C, O'Brien S, Dunne A, Ni Muircheartaigh R, Phelan D. Changes in Multidisciplinary Tracheostomy Team Practice Over Time. Ir Med J. 2021 Sep 20;114(8):433. PMID 35863078
• Mikhaeil M, Bernard M, Currie J, Bolduc C, Radke J, Kranjc S, Meyer J. Improving weaning and liberation from mechanical ventilation for tracheostomy patients: a quality improvement initiative. BMJ Qual Saf. 2025 Jun 19;34(7):480-488. doi: 10.1136/bmjqs-2024-018324. PMID 40318863
• 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
• Brenner MJ, Davies EA, McGrath BA. Reducing variation in tracheostomy care can improve outcomes. Br J Anaesth. 2022 Apr;128(4):e282-e284. doi: 10.1016/j.bja.2022.01.008. Epub 2022 Feb 8. No abstract available. PMID 35144800
• 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
• Gentile MN, Irvine AD, King AM, Hembrom AS, Guruswamy KS, Palivela NE, Langton-Frost N, McElroy CR, Pandian V. Enhancing Communication in Critically Ill Patients with a Tracheostomy: A Systematic Review of Evidence-Based Interventions and Outcomes. Tracheostomy. 2024;1(1):26-41. doi: 10.62905/001c.115440. Epub 2024 Mar 31. PMID 39253605
• Damuth E, Mitchell JA, Bartock JL, Roberts BW, Trzeciak S. Long-term survival of critically ill patients treated with prolonged mechanical ventilation: a systematic review and meta-analysis. Lancet Respir Med. 2015 Jul;3(7):544-53. doi: 10.1016/S2213-2600(15)00150-2. Epub 2015 May 20. PMID 26003390
• Dempsey GA, Morton B, Hammell C, Williams LT, Tudur Smith C, Jones T. Long-Term Outcome Following Tracheostomy in Critical Care: A Systematic Review. Crit Care Med. 2016 Mar;44(3):617-28. doi: 10.1097/CCM.0000000000001382. PMID 26584197
• 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
• 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
• Villemure-Poliquin N, Lessard Bonaventure P, Costerousse O, Rouleau-Bonenfant T, Zarychanski R, Lauzier F, Audet N, Moore L, Gagnon MA, Turgeon AF. Impact of Early Tracheostomy Versus Late or No Tracheostomy in Nonneurologically Injured Adult Patients: A Systematic Review and Meta-Analysis. Crit Care Med. 2023 Feb 1;51(2):310-318. doi: 10.1097/CCM.0000000000005699. Epub 2022 Dec 7. PMID 36661455
• Sutt AL, Tronstad O, Barnett AG, Kitchenman S, Fraser JF. Earlier tracheostomy is associated with an earlier return to walking, talking, and eating. Aust Crit Care. 2020 May;33(3):213-218. doi: 10.1016/j.aucc.2020.02.006. Epub 2020 Apr 13. PMID 32299649
• Quinn L, Veenith T, Bion J, Hemming K, Whitehouse T, Lilford R. Bayesian analysis of a systematic review of early versus late tracheostomy in ICU patients. Br J Anaesth. 2022 Nov;129(5):693-702. doi: 10.1016/j.bja.2022.08.012. Epub 2022 Sep 24. PMID 36163077
• Deng H, Fang Q, Chen K, Zhang X. Early versus late tracheotomy in ICU patients: A meta-analysis of randomized controlled trials. Medicine (Baltimore). 2021 Jan 22;100(3):e24329. doi: 10.1097/MD.0000000000024329. PMID 33546065
• Cinotti R, Voicu S, Jaber S, Chousterman B, Paugam-Burtz C, Oueslati H, Damoisel C, Caillard A, Roquilly A, Feuillet F, Mebazaa A, Gayat E; FROG-ICU investigators. Tracheostomy and long-term mortality in ICU patients undergoing prolonged mechanical ventilation. PLoS One. 2019 Oct 2;14(10):e0220399. doi: 10.1371/journal.pone.0220399. eCollection 2019. PMID 31577804
• Arabi Y, Haddad S, Shirawi N, Al Shimemeri A. Early tracheostomy in intensive care trauma patients improves resource utilization: a cohort study and literature review. Crit Care. 2004 Oct;8(5):R347-52. doi: 10.1186/cc2924. Epub 2004 Aug 23. PMID 15469579
• 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
• Siempos II, Ntaidou TK, Filippidis FT, Choi AMK. Effect of early versus late or no tracheostomy on mortality and pneumonia of critically ill patients receiving mechanical ventilation: a systematic review and meta-analysis. Lancet Respir Med. 2015 Feb;3(2):150-158. doi: 10.1016/S2213-2600(15)00007-7. PMID 25680911
• 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
• Cagino LM, Kercheval JB, Kenes MT, McSparron JI, Blank R, Chinn SB, Claar DD, Iwashyna TJ, De Cardenas J. Association of Tracheostomy with Changes in Sedation during COVID-19: A Quality Improvement Evaluation at the University of Michigan. Ann Am Thorac Soc. 2021 May;18(5):907-909. doi: 10.1513/AnnalsATS.202009-1096RL. No abstract available. PMID 33233918
• Lais G, Piquilloud L. Tracheostomy: update on why, when and how. Curr Opin Crit Care. 2025 Feb 1;31(1):101-107. doi: 10.1097/MCC.0000000000001224. Epub 2024 Nov 25. PMID 39588741
• Diehl JL, El Atrous S, Touchard D, Lemaire F, Brochard L. Changes in the work of breathing induced by tracheotomy in ventilator-dependent patients. Am J Respir Crit Care Med. 1999 Feb;159(2):383-8. doi: 10.1164/ajrccm.159.2.9707046. PMID 9927347
• Young D, Harrison DA, Cuthbertson BH, Rowan K; TracMan Collaborators. Effect of early vs late tracheostomy placement on survival in patients receiving mechanical ventilation: the TracMan randomized trial. JAMA. 2013 May 22;309(20):2121-9. doi: 10.1001/jama.2013.5154. PMID 23695482
• Terragni PP, Antonelli M, Fumagalli R, Faggiano C, Berardino M, Pallavicini FB, Miletto A, Mangione S, Sinardi AU, Pastorelli M, Vivaldi N, Pasetto A, Della Rocca G, Urbino R, Filippini C, Pagano E, Evangelista A, Ciccone G, Mascia L, Ranieri VM. Early vs late tracheotomy for prevention of pneumonia in mechanically ventilated adult ICU patients: a randomized controlled trial. JAMA. 2010 Apr 21;303(15):1483-9. doi: 10.1001/jama.2010.447. PMID 20407057
• 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 36693401