Effect of Titrating Positive End-Expiratory Pressure (PEEP) with an Esophageal Pressure-Guided Strategy vs an Empirical High PEEP-F io 2 Strategy on Death and Days Free from Mechanical Ventilation among Patients with Acute Respiratory Distress Syndrome: A Randomized Clinical Trial

JAMA - Journal of the American Medical Association

Volumn 321, Issue 9, 2019, Pages 846-857

  Beitler, Jeremy R ^a   Sarge, Todd ^b   Banner Goodspeed, Valerie M ^b   Gong, Michelle N ^c   Cook, Deborah ^d   Novack, Victor ^e   Loring, Stephen H ^b   Talmor, Daniel ^b  

^a College of Physicians and Surgeons ^*  (United States)

^b HARVARD MEDICAL SCHOOL   (United States)

^c ALBERT EINSTEIN COLLEGE OF MEDICINE   (United States)

^d ST JOSEPH S HOSPITAL   (Canada)

^e BEN GURION UNIVERSITY OF THE NEGEV   (Israel)

Author keywords

[No Author keywords available]

Indexed keywords

ADULT; ADULT RESPIRATORY DISTRESS SYNDROME; ARTIFICIAL VENTILATION; BAROTRAUMA; CLINICAL EFFECTIVENESS; COMPARATIVE STUDY; CONFERENCE PAPER; CONTROLLED STUDY; DEATH; DISEASE SEVERITY; ESOPHAGUS PRESSURE; FEMALE; FOLLOW UP; HUMAN; INSPIRATORY CAPACITY; MAJOR CLINICAL STUDY; MALE; MIDDLE AGED; NORTH AMERICA; OXYGEN BREATHING; POSITIVE END EXPIRATORY PRESSURE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SCORING SYSTEM; SURVIVOR; THORAX PRESSURE; TIDAL VOLUME; AGED; CLINICAL TRIAL; ESOPHAGUS; MORTALITY; MULTICENTER STUDY; PATHOPHYSIOLOGY; PHASE 2 CLINICAL TRIAL; PRESSURE; PROCEDURES; RESPIRATORY FUNCTION;

ADULT; AGED; ESOPHAGUS; FEMALE; HUMANS; MALE; MIDDLE AGED; POSITIVE-PRESSURE RESPIRATION; PRESSURE; RESPIRATORY DISTRESS SYNDROME, ADULT; RESPIRATORY PHYSIOLOGICAL PHENOMENA;

EID: 85061571610     PISSN: 00987484     EISSN: 15383598     Source Type: Journal    
DOI: 10.1001/jama.2019.0555     Document Type: Conference Paper

References (40)

1. Slutsky AS, Ranieri VM. Ventilator-induced lung injury. N Engl J Med. 2013; 369 (22): 2126-2136. doi: 10.1056/NEJMra1208707 24283226
2. Amato MB, Barbas CS, Medeiros DM, Effect of a protective-ventilation strategy on mortality in the acute respiratory distress syndrome. N Engl J Med. 1998; 338 (6): 347-354. doi: 10.1056/NEJM199802053380602 9449727
3. Brower RG, Matthay MA, Morris A, Schoenfeld D, Thompson BT, Wheeler A; Acute Respiratory Distress Syndrome Network. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med. 2000; 342 (18): 1301-1308. doi: 10.1056/NEJM200005043421801 10793162
4. Talmor D, Sarge T, O'Donnell CR, Esophageal and transpulmonary pressures in acute respiratory failure. Crit Care Med. 2006; 34 (5): 1389-1394. doi: 10.1097/01.CCM.0000215515.49001.A2 16540960
5. Loring SH, O'Donnell CR, Behazin N, Esophageal pressures in acute lung injury: do they represent artifact or useful information about transpulmonary pressure, chest wall mechanics, and lung stress? J Appl Physiol (1985). 2010; 108 (3): 515-522. doi: 10.1152/japplphysiol.00835.2009 20019160
6. Beitler JR, Majumdar R, Hubmayr RD, Volume delivered during recruitment maneuver predicts lung stress in acute respiratory distress syndrome. Crit Care Med. 2016; 44 (1): 91-99. doi: 10.1097/CCM.0000000000001355 26474111
7. Talmor D, Sarge T, Malhotra A, Mechanical ventilation guided by esophageal pressure in acute lung injury. N Engl J Med. 2008; 359 (20): 2095-2104. doi: 10.1056/NEJMoa0708638 19001507
8. Ferguson ND, Cook DJ, Guyatt GH,; OSCILLATE Trial Investigators; Canadian Critical Care Trials Group. High-frequency oscillation in early acute respiratory distress syndrome. N Engl J Med. 2013; 368 (9): 795-805. doi: 10.1056/NEJMoa1215554 23339639
9. Mercat A, Richard J-CM, Vielle B,; Expiratory Pressure (Express) Study Group. Positive end-expiratory pressure setting in adults with acute lung injury and acute respiratory distress syndrome: a randomized controlled trial. JAMA. 2008; 299 (6): 646-655. doi: 10.1001/jama.299.6.646 18270353
10. Meade MO, Cook DJ, Guyatt GH,; Lung Open Ventilation Study Investigators. Ventilation strategy using low tidal volumes, recruitment maneuvers, and high positive end-expiratory pressure for acute lung injury and acute respiratory distress syndrome: a randomized controlled trial. JAMA. 2008; 299 (6): 637-645. doi: 10.1001/jama.299.6.637 18270352
11. Brower RG, Lanken PN, MacIntyre N,; National Heart, Lung, and Blood Institute ARDS Clinical Trials Network. Higher versus lower positive end-expiratory pressures in patients with the acute respiratory distress syndrome. N Engl J Med. 2004; 351 (4): 327-336. doi: 10.1056/NEJMoa032193 15269312
12. Huang DT, Angus DC, Moss M,; Reevaluation of Systemic Early Neuromuscular Blockade Protocol Committee and the National Institutes of Health National Heart, Lung, and Blood Institute Prevention and Early Treatment of Acute Lung Injury Network Investigators. Design and rationale of the reevaluation of systemic early neuromuscular blockade trial for acute respiratory distress syndrome. Ann Am Thorac Soc. 2017; 14 (1): 124-133. doi: 10.1513/AnnalsATS.201608-629OT 27779896
13. Briel M, Meade M, Mercat A, Higher vs lower positive end-expiratory pressure in patients with acute lung injury and acute respiratory distress syndrome: systematic review and meta-analysis. JAMA. 2010; 303 (9): 865-873. doi: 10.1001/jama.2010.218 20197533
14. Fish E, Novack V, Banner-Goodspeed VM, Sarge T, Loring S, Talmor D. The Esophageal Pressure-Guided Ventilation 2 (EPVent2) trial protocol: a multicentre, randomised clinical trial of mechanical ventilation guided by transpulmonary pressure. BMJ Open. 2014; 4 (9): e006356. doi: 10.1136/bmjopen-2014-006356 25287106
15. Ranieri VM, Rubenfeld GD, Thompson BT,; ARDS Definition Task Force. Acute respiratory distress syndrome: the Berlin Definition. JAMA. 2012; 307 (23): 2526-2533. doi: 10.1001/jama.2012.5669 22797452
16. Finkelstein DM, Schoenfeld DA. Combining mortality and longitudinal measures in clinical trials. Stat Med. 1999; 18 (11): 1341-1354. doi: 10.1002/(SICI)1097-0258(19990615)18:11<1341::AID-SIM129>3.0.CO;2-7 10399200
17. Acion L, Peterson JJ, Temple S, Arndt S. Probabilistic index: an intuitive non-parametric approach to measuring the size of treatment effects. Stat Med. 2006; 25 (4): 591-602. doi: 10.1002/sim.2256 16143965
18. Kraemer HC. Correlation coefficients in medical research: from product moment correlation to the odds ratio. Stat Methods Med Res. 2006; 15 (6): 525-545. doi: 10.1177/0962280206070650 17260922
19. Schoenfeld DA, Bernard GR; ARDS Network. Statistical evaluation of ventilator-free days as an efficacy measure in clinical trials of treatments for acute respiratory distress syndrome. Crit Care Med. 2002; 30 (8): 1772-1777. doi: 10.1097/00003246-200208000-00016 12163791
20. Newcombe RG. Confidence intervals for an effect size measure based on the Mann-Whitney statistic, part 2: asymptotic methods and evaluation. Stat Med. 2006; 25 (4): 559-573. doi: 10.1002/sim.2324 16217835
21. Lin DY, Wei LJ, Ying Z. Checking the Cox model with cumulative sums of martingale-based residuals. Biometrika. 1993; 80: 557-572. doi: 10.1093/biomet/80.3.557
22. Hodges JL, Lehmann EL. Estimates of location based on rank tests. Ann Math Stat. 1963; 34 (2): 598-611. doi: 10.1214/aoms/1177704172
23. Oeckler RA, Lee W-Y, Park M-G, Determinants of plasma membrane wounding by deforming stress. Am J Physiol Lung Cell Mol Physiol. 2010; 299 (6): L826-L833. doi: 10.1152/ajplung.00217.2010 20889673
24. Bilek AM, Dee KC, Gaver DP III. Mechanisms of surface-tension-induced epithelial cell damage in a model of pulmonary airway reopening. J Appl Physiol (1985). 2003; 94 (2): 770-783. doi: 10.1152/japplphysiol.00764.2002 12433851
25. Gattinoni L, Caironi P, Cressoni M, Lung recruitment in patients with the acute respiratory distress syndrome. N Engl J Med. 2006; 354 (17): 1775-1786. doi: 10.1056/NEJMoa052052 16641394
26. Caironi P, Cressoni M, Chiumello D, Lung opening and closing during ventilation of acute respiratory distress syndrome. Am J Respir Crit Care Med. 2010; 181 (6): 578-586. doi: 10.1164/rccm.200905-0787OC 19910610
27. Cornejo RA, Díaz JC, Tobar EA, Effects of prone positioning on lung protection in patients with acute respiratory distress syndrome. Am J Respir Crit Care Med. 2013; 188 (4): 440-448. doi: 10.1164/rccm.201207-1279OC 23348974
28. Cavalcanti AB, Suzumura ÉA, Laranjeira LN,; Writing Group for the Alveolar Recruitment for Acute Respiratory Distress Syndrome Trial (ART) Investigators. Effect of lung recruitment and titrated positive end-expiratory pressure (PEEP) vs low PEEP on mortality in patients with acute respiratory distress syndrome: a randomized clinical trial. JAMA. 2017; 318 (14): 1335-1345. doi: 10.1001/jama.2017.14171 28973363
29. Borges JB, Costa ELV, Suárez-Sipmann F, Early inflammation mainly affects normally and poorly aerated lung in experimental ventilator-induced lung injury. Crit Care Med. 2014; 42 (4): e279-e287. doi: 10.1097/CCM.0000000000000161 24448197
30. Steinberg JM, Schiller HJ, Halter JM, Alveolar instability causes early ventilator-induced lung injury independent of neutrophils. Am J Respir Crit Care Med. 2004; 169 (1): 57-63. doi: 10.1164/rccm.200304-544OC 14695106
31. Baedorf Kassis E, Loring SH, Talmor D. Mortality and pulmonary mechanics in relation to respiratory system and transpulmonary driving pressures in ARDS. Intensive Care Med. 2016; 42 (8): 1206-1213. doi: 10.1007/s00134-016-4403-7 27318943
32. Gattinoni L, Pelosi P, Suter PM, Pedoto A, Vercesi P, Lissoni A. Acute respiratory distress syndrome caused by pulmonary and extrapulmonary disease: different syndromes? Am J Respir Crit Care Med. 1998; 158 (1): 3-11. doi: 10.1164/ajrccm.158.1.9708031 9655699
33. Terragni P, Mascia L, Fanelli V, Biondi-Zoccai G, Ranieri VM. Accuracy of esophageal pressure to assess transpulmonary pressure during mechanical ventilation. Intensive Care Med. 2017; 43 (1): 142-143. doi: 10.1007/s00134-016-4589-8 27744540
34. Washko GR, O'Donnell CR, Loring SH. Volume-related and volume-independent effects of posture on esophageal and transpulmonary pressures in healthy subjects. J Appl Physiol (1985). 2006; 100 (3): 753-758. doi: 10.1152/japplphysiol.00697.2005 16306256
35. Pelosi P, Goldner M, McKibben A, Recruitment and derecruitment during acute respiratory failure: an experimental study. Am J Respir Crit Care Med. 2001; 164 (1): 122-130. doi: 10.1164/ajrccm.164.1.2007010 11435250
36. Lai-Fook SJ, Rodarte JR. Pleural pressure distribution and its relationship to lung volume and interstitial pressure. J Appl Physiol (1985). 1991; 70 (3): 967-978. doi: 10.1152/jappl.1991.70.3.967 2033012
37. Guérin C, Reignier J, Richard J-C,; PROSEVA Study Group. Prone positioning in severe acute respiratory distress syndrome. N Engl J Med. 2013; 368 (23): 2159-2168. doi: 10.1056/NEJMoa1214103 23688302
38. Beitler JR, Guérin C, Ayzac L, PEEP titration during prone positioning for acute respiratory distress syndrome. Crit Care. 2015; 19: 436. doi: 10.1186/s13054-015-1153-9 26686509
39. Calfee CS, Delucchi K, Parsons PE, Thompson BT, Ware LB, Matthay MA; NHLBI ARDS Network. Subphenotypes in acute respiratory distress syndrome: latent class analysis of data from two randomised controlled trials. Lancet Respir Med. 2014; 2 (8): 611-620. doi: 10.1016/S2213-2600(14)70097-9 24853585
40. Famous KR, Delucchi K, Ware LB,; ARDS Network. Acute respiratory distress syndrome subphenotypes respond differently to randomized fluid management strategy. Am J Respir Crit Care Med. 2017; 195 (3): 331-338. doi: 10.1164/rccm.201603-0645OC 27513822