Rationale, study design and analysis plan of the lung imaging morphology for ventilator settings in acute respiratory distress syndrome study (LIVE study): Study protocol for a randomised controlled trial

Anaesthesia Critical Care and Pain Medicine

Volumn 36, Issue 5, 2017, Pages 301-306

  Jabaudon, Matthieu ^a,b   Godet, Thomas ^a,b   Futier, Emmanuel ^a,b   Bazin, Jean Étienne ^a   Sapin, Vincent ^a,b   Roszyk, Laurence ^a,b   Pereira, Bruno ^a   Constantin, Jean Michel ^a,b  

^a UNIVERSITY HOSPITAL OF CLERMONT FERRAND   (France)

^b UNIVERSITÉ CLERMONT AUVERGNE   (France)

Author keywords

ARDS; ARDS phenotype; Lung morphology; Mechanical ventilation; Personalized medicine

Indexed keywords

OXYGEN;

ADULT; ADULT RESPIRATORY DISTRESS SYNDROME; AIRWAY PRESSURE; ALL CAUSE MORTALITY; ARTICLE; BAROTRAUMA; CHEMICAL PARAMETERS; CLINICAL OUTCOME; COMPUTER ASSISTED TOMOGRAPHY; CONTROLLED STUDY; DISEASE ASSOCIATION; DISEASE SEVERITY; ECHOGRAPHY; FEMALE; HOSPITAL MORTALITY; HOSPITALIZATION; HUMAN; INTENSIVE CARE UNIT; LENGTH OF STAY; LUNG PARENCHYMA; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; PNEUMONIA; POSITIVE END EXPIRATORY PRESSURE; PRONE POSITION; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; SINGLE BLIND PROCEDURE; THORAX RADIOGRAPHY; TIDAL VOLUME; TISSUE STRUCTURE; YOUNG ADULT; AGED; ANATOMY AND HISTOLOGY; ARTIFICIAL VENTILATION; BODY WEIGHT; DIAGNOSTIC IMAGING; KAPLAN MEIER METHOD; LUNG; MECHANICAL VENTILATOR; METHODOLOGY; MIDDLE AGED; MORTALITY; PROCEDURES; RANDOMIZED CONTROLLED TRIAL (TOPIC); STANDARDS; TREATMENT OUTCOME; X-RAY COMPUTED TOMOGRAPHY;

ADULT; AGED; BODY WEIGHT; FEMALE; HOSPITAL MORTALITY; HUMANS; KAPLAN-MEIER ESTIMATE; LUNG; MALE; MIDDLE AGED; OXYGEN; POSITIVE-PRESSURE RESPIRATION; PRONE POSITION; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RESEARCH DESIGN; RESPIRATION, ARTIFICIAL; RESPIRATORY DISTRESS SYNDROME, ADULT; TIDAL VOLUME; TOMOGRAPHY, X-RAY COMPUTED; TREATMENT OUTCOME; ULTRASONOGRAPHY; VENTILATORS, MECHANICAL;

EID: 85017514660     PISSN: None     EISSN: 23525568     Source Type: Journal    
DOI: 10.1016/j.accpm.2017.02.006     Document Type: Article

References (25)

1. Bellani, G., Laffey, J.G., Pham, T., Fan, E., Brochard, L., Esteban, A., et al. Epidemiology. Patterns of care and mortality for patients with acute respiratory distress syndrome in intensive care units in 50 countries. JAMA 315 (2016), 788–813, 10.1001/jama.2016.0291.
2. Herridge, M.S., Tansey, C.M., Matté, A., Tomlinson, G., Diaz-Granados, N., Cooper, A., et al. Functional disability 5 years after acute respiratory distress syndrome. N Engl J Med 364 (2011), 1293–1304, 10.1056/NEJMoa1011802.
3. Needham, D.M., Yang, T., Dinglas, V.D., Mendez-Tellez, P.A., Shanholtz, C., Sevransky, J.E., et al. Timing of low tidal volume ventilation and intensive care unit mortality in acute respiratory distress syndrome. A prospective cohort study. Am J Respir Crit Care Med 191 (2015), 177–185, 10.1164/rccm.201409-1598OC.
4. Protti, A., Cressoni, M., Santini, A., Langer, T., Mietto, C., Febres, D., et al. Lung stress and strain during mechanical ventilation: any safe threshold?. Am J Respir Crit Care Med 19:183 (2011), 1354–1362, 10.1164/rccm.201010-1757OC.
5. Mercat, A., Richard J-CM, Vielle, B., Jaber, S., Osman, D., Diehl, J.-L., et al. Positive end-expiratory pressure setting in adults with acute lung injury and acute respiratory distress syndrome: a randomized controlled trial. Jama 299 (2008), 646–655, 10.1001/jama.299.6.646.
6. Brower, R.G., Lanken, P.N., MacIntyre, N., Matthay, M.A., Morris, A., Ancukiewicz, M., et al. Higher versus lower positive end-expiratory pressures in patients with the acute respiratory distress syndrome. N Engl J Med 351 (2004), 327–336, 10.1056/NEJMoa032193.
7. Bloomfield, R., Noble, D.W., Sudlow, A., Prone position for acute respiratory failure in adults. 1996, John Wiley & Sons, Ltd, Chichester, UK, 10.1002/14651858.CD008095.pub2.
8. The, A.R.D.S., Definition Task Force. Acute respiratory distress syndrome. The Berlin definition. The Berlin definition of ARDS. JAMA 307 (2012), 1–2533, 10.1001/jama.2012.5669.
9. Gattinoni, L., Caironi, P., Cressoni, M., Chiumello, D., Ranieri, V.M., Quintel, M., et al. Lung recruitment in patients with the acute respiratory distress syndrome. N Engl J Med 354 (2006), 1775–1786, 10.1056/NEJMoa052052.
10. Rouby, J., Puybasset, L., Nieszkowska, A., Lu, Q., Acute respiratory distress syndrome: lessons from computed tomography of the whole lung. Crit Care Med, 31, 2003, S285.
11. Calfee, C.S., Janz, D.R., Bernard, G.R., May, A.K., Kangelaris, K.N., Matthay, M.A., et al. Distinct molecular phenotypes of direct versus indirect ARDS in single and multi-center studies. Chest 147:6 (2015), 1539–1548, 10.1378/chest.14-2454.
12. Calfee, C.S., Delucchi, K., Parsons, P.E., Thompson, B.T., Ware, L.B., Matthay, M.A., et al. Subphenotypes in acute respiratory distress syndrome: latent class analysis of data from two randomised controlled trials. Lancet Respir Med 2:8 (2014), 611–620, 10.1016/S2213-2600(14)70097-9.
13. Mrozek, S., Jabaudon, M., Jaber, S., Paugam-Burtz, Lefrant, J.-Y., Rouby, J.-J., et al. Elevated plasma levels of sRAGE are associated with nonfocal CT-based lung imaging in patients with ARDS: a prospective multicenter study. Chest 150 (2016), 998–1007, 10.1016/j.chest.2016.03.016.
14. Jabaudon, M., Blondonnet, R., Lutz, J., Roszyk, L., Bouvier, D., Guérin, R., et al. Net alveolar fluid clearance is associated with lung morphology phenotypes in acute respiratory distress syndrome. Anaesth Crit Care Pain Med 35:2 (2016), 81–86, 10.1016/j.accpm.2015.11.006.
15. Constantin, J.-M., Grasso, S., Chanques, G., Aufort, S., Futier, E., Sebbane, M., et al. Lung morphology predicts response to recruitment maneuver in patients with acute respiratory distress syndrome. Crit Care Med 38 (2010), 1108–1117, 10.1097/CCM.0b013e3181d451ec.
16. Puybasset, L., Gusman, P., Muller, J., Cluzel, P., Coriat, P., Rouby, J., Regional distribution of gas and tissue in acute respiratory distress syndrome III. Consequences for the effects of positive end-expiratory pressure. Intensive Care Med 26 (2000), 1215–1227.
17. Brower, R., Lanken, P., MacIntyre, N., Matthay, M., Morris, A., Ancukiewicz, M., et al. Higher versus lower positive end-expiratory pressures in patients with the acute respiratory distress syndrome. N Engl J Med, 351, 2004, 327.
18. Papazian, L., Forel, J., Gacouin, A., Penot-Ragon, C., Perrin, G., Loundou, A., et al. Neuromuscular blockers in early acute respiratory distress syndrome. N Engl J Med 363 (2010), 1107–1116.
19. Mrozek, S., Jabaudon, M., Jaber, S., Paugam-Burtz, C., Lefrant, J.-Y., Rouby, J.-J., et al. Elevated plasma levels of sRAGE are associated with non-focal CT-based lung imaging in ARDS patients: a prospective multicenter study. Chest, 2016, 1–31, 10.1016/j.chest.2016.03.016.
20. Signorini, D.F., Leung, O., Simes, R.J., Beller, E., Gebski, V.J., Callaghan, T., Dynamic balanced randomization for clinical trials. Stat Med 12 (1993), 2343–2350.
21. Amato, M.B., Barbas, C.S., Medeiros, D.M., Magaldi, R.B., Schettino, G.P., Lorenzi-Filho, G., et al. Effect of a protective-ventilation strategy on mortality in the acute respiratory distress syndrome. N Engl J Med 338 (1998), 347–354.
22. de Campos, T., Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. The acute respiratory distress syndrome network. N Engl J Med 342 (2000), 1301–1308.
23. Guérin, C., Reignier, J., Richard, J.-C., Beuret, P., Gacouin, A., Boulain, T., et al. Prone positioning in severe acute respiratory distress syndrome. N Engl J Med, 130520110015000, 2013, 10.1056/NEJMoa1214103.
24. Papazian, L., Forel, J.-M., Gacouin, A., Penot-Ragon, C., Perrin, G., Loundou, A., et al. Neuromuscular blockers in early acute respiratory distress syndrome. N Engl J Med 363 (2010), 1107–1116, 10.1056/NEJMoa1005372.
25. Taccone, P., Pesenti, A., Latini, R., Polli, F., Vagginelli, F., Mietto, C., et al. Prone positioning in patients with moderate and severe acute respiratory distress syndrome: a randomized controlled trial. Jama, 302, 2009, 1977.