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JAMA. 2019 Jun 3. doi: 10.1001/jama.2019.7505. [Epub ahead of print]

Effect of Intraoperative High Positive End-Expiratory Pressure (PEEP) With Recruitment Maneuvers vs Low PEEP on Postoperative Pulmonary Complications in Obese Patients: A Randomized Clinical Trial.

Collaborators (315)

Bluth T, Ilona, Canet JC, de Baerdemaeker, Gregoretti, Hedenstierna G, Hemmes SNT, Hiesmayr M, Hollmann, Jaber, Laffey, Licker, Markstaller, Matot I, Mills, Mulier JP, Putensen C, Rossaint, Schmitt, Senturk, Severgnini, Sprung, Vidal Melo MF, Wrigge, Serpa Neto, Schultz MJ, Pelosi, Gama de Abreu, Abelha, Abitağaoğlu, Achilles, Adebesin, Adriaensens, Ahene, Akbar, Al Harbi, Al Khoury al Kallab, Albanel, Aldenkortt F, Abdullah Saleh Alfouzan, Alruqaie R, Altermatt F, Araujo, Arbesú G, Artsi, Aurilio C, Ayanoglu, Bacuzzi A, Baig H, Baird, Balonov K, Balust J, Banks S, Bao, Baumgartner M, Belda Tortosa, Bergamaschi, Bergmann L, Bigatello L, Biosca Pérez E, Birr, Bluth, Bojaxhi E, Bonenti C, Bonney I, Bos EME, Bowman, Braz LG, Brugnoni, Brunetti I, Bruni, Buenvenida SL, Camerini, Canet J, Capatti B, Carmona J, Carungcong, Carvalho, Cattan A, Cavaleiro, Chiumello, Ciardo, Coburn, Colella U, Contreras, Corman Dincer, Cotter E, Crovetto M, Crovetto, Darrah W, Davies S, de Baerdemaeker L, De Hert, Del Cojo Peces, Delphin E, Diaper J, do Nascimento Junior, Donatiello, Dong J, do Socorro Dourado M, Dullenkopf A, Ebner F, Elgendy H, Ellenberger C, Erdoğan Arı, Ermert T, Farah, Fernandez-Bustamante, Ferreira C, Fiore M, Fonte, Fortià Palahí C, Galimberti, Gama de Abreu, Garofano, Giaccari LG, Gilsanz, Girrbach F, Gobbi L, Godfried, Goettel, Goldstein PA, Goren, Gorlin, Granell Gil, Gratarola A, Graterol, Guyon, Haire K, Harou, Helf, Hemmes SNT, Hempel, Hernández Cádiz MJ, Heyse, Hollmann MW, Huercio I, Ilievska, Jakus, Jeganath V, Jelting, Jung, Kabon B, Kacha A, Karaman Ilić M, Karuppiah A, Kavas AD, Keli Barcelos G, Kellogg TA, Kemper, Kerbrat R, Khodr, Kienbaum, Kir, Kiss T, Kivrak, Klarić, Koch, Köksal, Kowark A, Kranke, Kuvaki B, Kuzmanovska, Laffey, Lange, de Lemos, Licker MJ, López-Baamonde M, López-Hernández, Lopez-Martinez, Luise, MacGregor, Magalhães D, Maillard, Malerbi, Manimekalai, Margarson M, Markstaller, Martin, Martin YN, Martínez-Ocon J, Martin-Loeches I, Maseda E, Matot I, McAuliffe, McKenzie, Medina, Meersch M, Menzen, Mertens, Meurer B, Meyer-Treschan T, Miao C, Micalizzi, Milić, Módolo, Moine P, Mölders P, Montero-Feijoo A, Moret, Muller MK, Murphy, Nalwaya, Naumovski F, Navalesi P, Navarro e Lima LH, Nesek Adam, Neumann C, Newell, Nisnevitch Z, Nizamuddin, Novazzi C, O’Connor, Oprea, Orhan Sungur M, Özbilgin Ş, Pace MC, Pacheco, Packianathaswamy, Palma Gonzalez, Papaspyros, Paredes, Passavanti, Pedemonte, Pelosi P, Peremin, Philipsenburg, Pinho, Pinho, Posthuma, Pota V, Preckel, Priani, Putensen C, Rached MA, Radoeshki A, Ragazzi, Rajamanickam T, Rajamohan A, Ramakrishna H, Rangarajan D, Reiterer C, Renew JR, Reynaud T, Rhys R, Rivas E, Robitzky L, Rossaint, Rubulotta F, Machado, Nunes, Sabbatini G, Sanahuja, Sansone P, Santos, Sayedalahl, Schaefer, Scharffenberg E, Scharffenberg, Schiffer, Schliewe N, Schorer, Schultz, Schumann, Selmo, Sendra, Senturk, Severgnini, Shaw, Shosholcheva, Sibai A, Simon, Simonassi F, Sinno C, Sivrikoz N, Skandalou V, Smith, Soares M, Socorro Artiles, Sousa Castro, Sousa, Spadaro, Sprung, Stamatakis E, Steiner, Stevenazzi, Suarez-de-la-Rica A, Suppan, Teichmann R, Tena Guerrero, Thiel, Tolós, Tore Altun, Tucci, Turnbull, Turudić, Unterberg M, Van Limmen, Van Nieuwenhove, Van Waesberghe, Vidal Melo MF, Vitković, Vivona, Vizcaychipi M, Volta, Weber, Weingarten TN, Wittenstein J, Wrigge, Wyffels P, Yagüe J, Yates, Yavru, Zac L, Zhong.

Author information

1
Department of Anesthesiology and Critical Care Medicine, Pulmonary Engineering Group, University Hospital Carl Gustav Carus, Technische Universität Dresden, Germany.
2
Department of Critical Care Medicine, Hospital Israelita Albert Einstein, Sao Paulo, Brazil.
3
Department of Intensive Care, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.
4
Department of Surgical Sciences and Integrated Diagnostics, University of Genoa, Policlinico San Martino, Genoa, Italy.

Abstract

Importance:

An intraoperative higher level of positive end-expiratory positive pressure (PEEP) with alveolar recruitment maneuvers improves respiratory function in obese patients undergoing surgery, but the effect on clinical outcomes is uncertain.

Objective:

To determine whether a higher level of PEEP with alveolar recruitment maneuvers decreases postoperative pulmonary complications in obese patients undergoing surgery compared with a lower level of PEEP.

Design, Setting, and Participants:

Randomized clinical trial of 2013 adults with body mass indices of 35 or greater and substantial risk for postoperative pulmonary complications who were undergoing noncardiac, nonneurological surgery under general anesthesia. The trial was conducted at 77 sites in 23 countries from July 2014-February 2018; final follow-up: May 2018.

Interventions:

Patients were randomized to the high level of PEEP group (n = 989), consisting of a PEEP level of 12 cm H2O with alveolar recruitment maneuvers (a stepwise increase of tidal volume and eventually PEEP) or to the low level of PEEP group (n = 987), consisting of a PEEP level of 4 cm H2O. All patients received volume-controlled ventilation with a tidal volume of 7 mL/kg of predicted body weight.

Main Outcomes and Measures:

The primary outcome was a composite of pulmonary complications within the first 5 postoperative days, including respiratory failure, acute respiratory distress syndrome, bronchospasm, new pulmonary infiltrates, pulmonary infection, aspiration pneumonitis, pleural effusion, atelectasis, cardiopulmonary edema, and pneumothorax. Among the 9 prespecified secondary outcomes, 3 were intraoperative complications, including hypoxemia (oxygen desaturation with Spo2 ≤92% for >1 minute).

Results:

Among 2013 adults who were randomized, 1976 (98.2%) completed the trial (mean age, 48.8 years; 1381 [69.9%] women; 1778 [90.1%] underwent abdominal operations). In the intention-to-treat analysis, the primary outcome occurred in 211 of 989 patients (21.3%) in the high level of PEEP group compared with 233 of 987 patients (23.6%) in the low level of PEEP group (difference, -2.3% [95% CI, -5.9% to 1.4%]; risk ratio, 0.93 [95% CI, 0.83 to 1.04]; P = .23). Among the 9 prespecified secondary outcomes, 6 were not significantly different between the high and low level of PEEP groups, and 3 were significantly different, including fewer patients with hypoxemia (5.0% in the high level of PEEP group vs 13.6% in the low level of PEEP group; difference, -8.6% [95% CI, -11.1% to 6.1%]; P < .001).

Conclusions and Relevance:

Among obese patients undergoing surgery under general anesthesia, an intraoperative mechanical ventilation strategy with a higher level of PEEP and alveolar recruitment maneuvers, compared with a strategy with a lower level of PEEP, did not reduce postoperative pulmonary complications.

Trial Registration:

ClinicalTrials.gov Identifier: NCT02148692.

PMID:
31157366
PMCID:
PMC6582260
[Available on 2019-12-03]
DOI:
10.1001/jama.2019.7505

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