LUNG SAFE: Large observational study to UNderstand the Global impact of Severe Acute respiratory FailurE

LUNG SAFE (Large observational study to UNderstand the Global impact of Severe Acute respiratory FailurE) is a multicentre, prospective, observational, 4-week inception cohort study, which has been carried out by the Acute Respiratory Failure section through the ESICM Trials Group. The study aimed to prospectively assess the burden of, management and therapeutic approaches to, and outcomes from acute hypoxaemic respiratory failure requiring ventilatory support, with a specific focus on ARDS as defined by the Berlin Definition.

LUNG SAFE (last Update 27 February 2023)

Papers Published /In Press:

  • McNicholas BA, Rezoagli E, Simpkin AJ, Khanna S, Suen JY, Yeung P, Brodie D, Li Bassi G, Pham T, Bellani G, Fraser JF, Laffey J; CCCC Consortium. Epidemiology and outcomes of early-onset AKI in COVID-19-related ARDS in comparison with non-COVID-19-related ARDS: insights from two prospective global cohort studies. Crit Care. 2023 Jan 5;27(1):3. doi: 10.1186/s13054-022-04294-5. PMID: 36604753 Free PMC article.
  • Amado-Rodríguez L, Rodríguez-Garcia R, Bellani G, Pham T, Fan E, Madotto F, Laffey JG, Albaiceta GM; LUNG SAFE investigators. Mechanical ventilation in patients with cardiogenic pulmonary edema: a sub-analysis of the LUNG SAFE study. J Intensive Care. 2022 Dec 25;10(1):55. doi: 10.1186/s40560-022-00648-x. PMID: 36567347 Free PMC article.
  • Rezoagli E, McNicholas BA, Madotto F, Pham T, Bellani G, Laffey JG; LUNG SAFE Investigators, the ESICM Trials Group. Presence of comorbidities alters management and worsens outcome of patients with acute respiratory distress syndrome: insights from the LUNG SAFE study. Ann Intensive Care. 2022 May 21;12(1):42. doi: 10.1186/s13613-022-01015-7. PMID: 35596885 Free PMC article.
  • Laake JH, Småstuen MC, Møller MH, Larsson A, Aslam TN, Hofsø K, Pham T, Fan E, Bellani G, Laffey JG; LUNG SAFE Investigators. Patient characteristics, management and outcomes in a Nordic subset of the “large observational study to understand the global impact of severe acute respiratory failure” (LUNG SAFE) study. Acta Anaesthesiol Scand. 2022 Jul;66(6):684-695. doi: 10.1111/aas.14069. Epub 2022 May 12. PMID: 35398892 Free PMC article.
  • Maddali MV, Churpek M, Pham T, Rezoagli E, Zhuo H, Zhao W, He J, Delucchi KL, Wang C, Wickersham N, McNeil JB, Jauregui A, Ke S, Vessel K, Gomez A, Hendrickson CM, Kangelaris KN, Sarma A, Leligdowicz A, Liu KD, Matthay MA, Ware LB, Laffey JG, Bellani G, Calfee CS, Sinha P; LUNG SAFE Investigators and the ESICM Trials Group. Validation and utility of ARDS subphenotypes identified by machine-learning models using clinical data: an observational, multicohort, retrospective analysis. Lancet Respir Med. 2022 Apr;10(4):367-377. doi: 10.1016/S2213-2600(21)00461-6. Epub 2022 Jan 10. PMID: 35026177
  • Pisani L, Algera AG, Neto AS, Azevedo L, Pham T, Paulus F, de Abreu MG, Pelosi P, Dondorp AM, Bellani G, Laffey JG, Schultz MJ; ERICC study investigators; LUNG SAFE study investigators; PRoVENT study investigators; PRoVENT-iMiC study investigators.Geoeconomic variations in epidemiology, ventilation management, and outcomes in invasively ventilated intensive care unit patients without acute respiratory distress syndrome: a pooled analysis of four observational studies. Lancet Glob Health. 2022 Feb;10(2):e227-e235. doi: 10.1016/S2214-109X(21)00485-X. Epub 2021 Dec 13. PMID: 34914899 Free PMC article.
  • Pham T, Pesenti A, Bellani G, et al. Outcome of acute hypoxaemic respiratory failure: insights from the LUNG SAFE Study. Eur Respir J 2021; 57: 2003317 [https://doi.org/10.1183/13993003.03317-2020].
  • Dumas G, Lemiale V, Rathi N, Cortegiani A, Pène F, Bonny V, Salluh J, Albaiceta GM, Soares M, Soubani AO, Canet E, Hanane T, Kouatchet A, Mokart D, Lebiedz P, Türkoğlu M, Coudroy R, Jeon K, Demoule A, Mehta S, Caruso P, Frat JP, Yang KY, Roca O, Laffey J, Timsit JF, Azoulay E, Darmon M. Survival in Immunocompromised Patients Ultimately Requiring Invasive Mechanical Ventilation: A Pooled Individual Patient Data Analysis. Am J Respir Crit Care Med. 2021 Jul 15;204(2):187-196. doi: 10.1164/rccm.202009-3575OC. PMID: 33751920.
  • Pham T, Pesenti A, Bellani G, Rubenfeld G, Fan E, Bugedo G, Lorente JA, Fernandes ADV, Van Haren F, Bruhn A, Rios F, Esteban A, Gattinoni L, Larsson A, McAuley DF, Ranieri M, Thompson BT, Wrigge H, Brochard LJ, Laffey JG; LUNG SAFE Investigators and the European Society of Intensive Care Medicine Trials Group. Outcome of acute hypoxaemic respiratory failure: insights from the LUNG SAFE Study. Eur Respir J. 2021 Jun 10;57(6):2003317. doi: 10.1183/13993003.03317-2020. Print 2021 Jun. PMID: 33334944
  • Dumas G, Cortegiani A, Rathi N, Albaiceta GM, Soares M, Soubani A, Hanane T, Mokart D Turkoglu M, Coudroy R, Jeon K,  Caruso P, Frat JP et al Survival in Immunocompromised Patients Ultimately Requiring Invasive Mechanical Ventilation: A pooled individual patient data analysis. Am J Resp Crit Care Med 2021 Mar 22. doi: 10.1164/rccm.202009-3575OC. PMID: 33751920
  • Pham T, Pesenti A, Bellani G, Rubenfeld G, Fan E, Bugedo G, Lorente J, do Vale Fernandes A, Van Haren F, Bruhn Cruz A, Rios F; Lorente JA; Esteban A, Gattinoni L, Larsson A, McAuley DF, Ranieri M, Thompson BT; Wrigge H, Slutsky AS, Laffey JG, Brochard L. Acute Hypoxemic Respiratory Failure and ARDS: insights from the LUNG SAFE Study. Eur Resp J 2021 (in press).
  • Madotto F, McNicholas B, Rezoagli E, Pham T, Laffey JG, Bellani G; LUNG SAFE Investigators; ESICM Trials Group. Death in hospital following ICU discharge: insights from the LUNG SAFE study. Crit Care. 2021 Apr 13;25(1):144. doi: 10.1186/s13054-021-03465-0. PMID: 33849625 Free PMC article.
  • Panwar R, Madotto F, Bellani G, Laffey JG, van Haren F. Compliance phenotypes in ARDS before Covid-19: Insights from the LUNGSAFE study. Am J Resp Crit Care Med 2020 Aug 17. doi: 10.1164/rccm.202005-2046OC. Online ahead of print. PMID: 3280514
  • Madotto F*, Rezoagli E*, McNicholas B, Pham T, Slutsky A Bellani G, Laffey JG. Patterns and impact of arterial CO2 management in patients with Acute Respiratory Distress Syndrome: Insights from the LUNG SAFE study. Chest 2020 Jun 23:S0012-3692(20)31731-1. doi: 10.1016/j.chest.2020.05.605.PMID: 32589951
  • Madotto F*, Rezoagli E*, McNicholas B, Pham T, Fan E, Brochard L, Bellani G, Laffey JG. Hyperoxemia and excess oxygen use in early acute respiratory distress syndrome: Insights from the LUNG SAFE study. Crit Care 2020 Mar 31;24(1):125. doi: 10.1186/s13054-020-2826-6.PMID: 32234077
  • Rezoagli E, McNicholas B, Pham T, Bellani G, Laffey JG. Lung-Kidney Cross-Talk in the Critically ill: Insights from the LUNG SAFE Study [Letter]. Intens Care Med 2020 May;46(5):1072-1073. doi: 10.1007/s00134-020-05962-2. Epub 2020 Feb 24.PMID: 32095847
  • McNicholas B, Madotto F, Pham T, Rezoagli E, Brochard L, Bellani G, Laffey JG. Demographics, management and outcome of females and males with acute respiratory distress syndrome in the LUNG SAFE prospective cohort study. Eur Respir J. 2019 Oct 17;54(4). pii: 1900609. doi: 10.1183/13993003.00609-2019. [PMID: 31346004].
  • Duggal A, Rezoagli E, Pham T, McNicholas B, Fan E, Bellani G, Rubenfeld G, Pesenti A, Laffey JG. Patterns of use of adjunctive therapies in patients with early moderate- severe Acute Respiratory Distress syndrome: Insights from the LUNG SAFE Study Chest 2020 (in press).
  • McNicholas BA, Rezoagli E, Pham T, Madotto F, Guaird E, Fanelle V, Bellani G, Griffin M, Ranieri VM, Laffey JG. Impact of early development of Acute Kidney Injury on management and outcome in patients with ARDS. Crit Care Med 2019 Sep;47(9):1216-1225. [PMID: 31162201]
  • Pham T, Serpa Neto A, Pelosi P, Laffey JG, De Haro C, Lorente JA, Bellani G, Fan E, Brochard LJ, Pesenti A, Schultz MJ, Artigas A. Risk factors for ARDS progression and mortality among patients with Mild ARDS: Insights from the LUNG SAFE study. Anesthesiology 2019 Feb;130(2):263-283. doi: 10.1097/ALN.0000000000002508. [PMID: 30499850]
  • van Haren F, Pham T, Brochard L, Bellani G, Laffey JG, Dres M, Fan E, Goligher E, Heunks L, Lynch J, Wrigge H, McAuley DF. Spontaneous breathing activity in early acute respiratory distress syndrome; An ancillary analysis of the LUNG SAFE study. Crit Care Med 2019 Feb;47(2):229-238. doi: 10.1097/CCM.0000000000003519. [PMID: 30379668]
  • McNicholas B, Madotto F, Pham T, Rezoagli E, Brochard L, Bellani G, Laffey JG. Impact of sex in patients with Acute Respiratory distress Syndrome: Insights from the LUNG. Eur Respir J. 2019 Oct 17;54(4). pii: 1900609. doi: 10.1183/13993003.00609-2019.. [PMID: 31346004].
  • Boyle AJ, Madotto F, Laffey JG, Bellani G, Pham T, Pesenti A, Thompson BT, O’Kane CM, Deane AM*, McAuley DF* on behalf of the LUNG SAFE Investigators and the ESICM Trials Group. Identifying associations between diabetes and ARDS in patients with AHRF: An analysis of the LUNG SAFE database. Critical Care 2018 Oct 27;22(1):268. doi: 10.1186/s13054-018-2158-y. [PMID: 30367670]
  • Abe T, Nagata I, Uchida M, Tamiya N, Kurahashi N, Madotto F, Bellani G, Laffey JG, for the LUNG SAFE Investigators and the ESICM Trials Group. Epidemiology and patterns of tracheostomy for patients with Acute Respiratory Distress Syndrome in Intensive Care Units in 50 countries. Critical Care 2018 Aug 17;22(1):195.
  • Cortegiani A, Madotto F, Gregoretti C, Bellani G, Laffey JG, Pham T, Antonelli M, Pesenti A, Grasselli G. Immunocompromised patients with ARDS: secondary analysis of the LUNG SAFE database. Crit Care 2018 Jun 12;22(1):157. doi: 10.1186/s13054-018-2079-9. [PMID: 29895331]
  • Madotto F, Bos LD, Simonis FD, Pham T, Bellani G, Fan E, Artigas A, Brochard L, Schultz MJ, Laffey JG, et al on behalf of the LUNG SAFE Investigators. Resolved versus confirmed ARDS after 24 h: insights from the LUNG SAFE study. Intens Care Med 2018 May;44(5):564-577. doi: 10.1007/s00134-018-5152-6. [PMID: 29632996]
  • Goddard, SL; Rubenfeld, GD, Manoharan V, Dev SP, Laffey JG, Bellani G, Pham T, Fan E. The Randomized Educational Acute Respiratory Distress Syndrome Diagnosis Study: A Trial to Improve the Radiographic Diagnosis of Acute Respiratory Distress Syndrome. Crit Care Med 2018 May;46(5):743-748. [PMID: 29438110]
  • de Prost N, Pham T, Carteaux G, Mekontso Dessap A, Brun-Buisson C, Fan E, Bellani G, Laffey JG, Mercat A, Brochard L, Maître B, LUNG SAFE investigators; ESICM trials group; REVA network. Etiologies, diagnostic work-up and outcomes of acute respiratory distress syndrome with no common risk factor: a prospective multicenter study. Ann Intens Care 2017 Dec;7(1):69 [PMID: 28631088]
  • Laffey JG, Madotto F, Bellani G, Pham T, Fan E, et al on behalf of the LUNG SAFE Investigators. Geoeconomic variations in epidemiology, patterns of care and outcome in patients with Acute Respiratory Distress in the LUNG SAFE study: the LUNG SAFE study Lancet Resp Med 2017, Aug;5(8):627-638. doi: 10.1016/S2213-2600(17)30213-8. [PMID: 28624388]
  • Bellani G, Laffey JG, Pham T, Madotto F, Fan E, Brochard L, Esteban A, Gattinoni L, Bumbasirevic V, Piquilloud L, van Haren F, Larsson A, McAuley DF, Bauer PR, Arabi YM, Ranieri M Md, Antonelli M, Rubenfeld GD, Thompson BT, Wrigge H, Slutsky AS, Pesenti A; LUNG SAFE Investigators and the ESICM Trials Group. Non-Invasive Ventilation in ARDS: Insights from the LUNG SAFE Study. Am J Respir Crit Care Med. 2017 Jan 1;195(1):67-77. [PMID: 27753501]
  • Laffey JG, Bellani G, Pham T, Fan E, Madotto F, Bajwa EK, Brochard L, Clarkson K, Esteban A, Gattinoni L, van Haren F, Heunks LM, Kurahashi K, Laake JH, Larsson A, McAuley DF, McNamee L, Nin N, Qiu H, Ranieri M, Rubenfeld GD, Thompson BT, Wrigge H, Slutsky AS, Pesenti A; LUNG SAFE Investigators and the ESICM Trials Group. Potentially modifiable factors contributing to outcome from Acute Respiratory Distress Syndrome: the LUNG SAFE study. Intens Care Med 2016 Dec;42(12):1865-1876 [PMID: 27757516].
  • Bellani G, Laffey JG, Pham T, Fan E, et al on behalf of the LUNG SAFE Investigators. Epidemiology, patterns of care, and mortality for patients with acute respiratory distress syndrome in intensive care units in 50 countries. JAMA Feb 23 2016, 315 (8): 788-800.

A number of OPEN LUNG SAFE proposals have been completed, and manuscripts are currently under consideration for publication in different journals.

The list of currently approved OPEN LUNG SAFE Projects is as follows:

  1. Impact of Resolving versus confirmed ARDS.
  2. Assessing the effect of diabetes in ARDS or AHRF
  3. Use of tracheostomy among mechanically ventilated patients with severe ARDS
  4. Management and outcome of Acute respiratory failure in immunocompromised patients
  5. Hyperoxia, oxygenation levels and targets in Patients with Acute Hypoxic Respiratory Failure
  6. Hypercapnia and management of arterial CO2 tension in patients with ARDS
  7. Impact of spontaneous breathing in early ARDS
  8. Role of ECMO in LUNG SAFE database
  9. Risk factors for progression from MILD to more severe ARDS
  10. The influence of obesity in patients with ARDS or AHRF
  11. Impact of gender in patients with ARDS in LUNG SAFE
  12. Impact of acute renal failure in patients with ARDS in LUNG SAFE
  13. Impact of comorbidities in patients with ARDS in LUNG SAFE
  14. Prone position in ARDS in LUNG SAFE
  15. Novel indices of mechanical ventilation in patients with ARDS.
  16. Factors influencing severity of hypoxemia and associated mortality in Severe Acute Hypoxemic Respiratory Failure
  17. Barriers to low tidal volume ventilation.
  18. End of life care decisions for the patient with severe respiratory failure in ICU
  19. The characteristics of prolonged ventilation in patients with acute respiratory failure
  20. How patients with ARDS are weaned from PEEP
  21. Structure of ICU and risk standardised mortality ratio in acute hypoxemic respiratory failure
  22. Changes over time in response to therapeutic manoeuvres

Documents

OPEN LUNG SAFE Data Access, Publication and Authorship Policy 

(there is no call out for proposals at the moment)


Contact

For more information, please contact research@esicm.org