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.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 2292-2305 |
| Number of pages | 14 |
| Journal | JAMA - Journal of the American Medical Association |
| Volume | 321 |
| Issue number | 23 |
| DOIs | |
| State | Published - Jun 18 2019 |
ASJC Scopus subject areas
- Medicine(all)
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In: JAMA - Journal of the American Medical Association, Vol. 321, No. 23, 18.06.2019, p. 2292-2305.
Research output: Contribution to journal › Article › peer-review
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TY - JOUR
T1 - Effect of Intraoperative High Positive End-Expiratory Pressure (PEEP) with Recruitment Maneuvers vs Low PEEP on Postoperative Pulmonary Complications in Obese Patients
T2 - A Randomized Clinical Trial
AU - Bluth, Thomas
AU - Serpa Neto, Ary
AU - Schultz, Marcus J.
AU - Pelosi, Paolo
AU - Gama de Abreu, Marcelo
AU - Bobek, Ilona
AU - Canet, Jaume C.
AU - Cinella, Gilda
AU - de Baerdemaeker, Luc
AU - Gregoretti, Cesare
AU - Hedenstierna, Göran
AU - Hemmes, Sabrine N.T.
AU - Hiesmayr, Michael
AU - Hollmann, Markus W.
AU - Jaber, Samir
AU - Laffey, John
AU - Licker, Marc Joseph
AU - Markstaller, Klaus
AU - Matot, Idit
AU - Mills, Gary H.
AU - Mulier, Jan Paul
AU - Putensen, Christian
AU - Rossaint, Rolf
AU - Schmitt, Jochen
AU - Senturk, Mert
AU - Severgnini, Paolo
AU - Sprung, Juraj
AU - Vidal Melo, Marcos Francisco
AU - Wrigge, Hermann
AU - Abelha, Fernando
AU - Abitagaoglu, Sühayla
AU - Achilles, Marc
AU - Adebesin, Afeez
AU - Adriaensens, Ine
AU - Ahene, Charles
AU - Akbar, Fatima
AU - Harbi, Mohammed Al
AU - Al Kallab, Rita Al Khoury
AU - Albanel, Xavier
AU - Aldenkortt, Florence
AU - Alfouzan, Rawan Abdullah Saleh
AU - Alruqaie, Reef
AU - Altermatt, Fernando
AU - de Castro Araujo, Bruno Luís
AU - Arbesú, Genaro
AU - Artsi, Hanna
AU - Aurilio, Caterina
AU - Ayanoglu, Omer Hilmi
AU - Bacuzzi, Alessandro
AU - Baig, Harris
AU - Baird, Yolanda
AU - Balonov, Konstantin
AU - Balust, Jaume
AU - Banks, Samantha
AU - Bao, Xiaodong
AU - Baumgartner, Mélanie
AU - Tortosa, Isabel Belda
AU - Bergamaschi, Alice
AU - Bergmann, Lars
AU - Bigatello, Luca
AU - Pérez, Elena Biosca
AU - Birr, Katja
AU - Bojaxhi, Elird
AU - Bonenti, Chiara
AU - Bonney, Iwona
AU - Bos, Elke M.E.
AU - Bowman, Sara
AU - Braz, Leandro Gobbo
AU - Brugnoni, Elisa
AU - Brull, Sorin J.
AU - Brunetti, Iole
AU - Bruni, Andrea
AU - Buenvenida, Shonie L.
AU - Busch, Cornelius Johannes
AU - Camerini, Giovanni
AU - Capatti, Beatrice
AU - Carmona, Javiera
AU - Carungcong, Jaime
AU - Carvalho, Marta
AU - Cattan, Anat
AU - Cavaleiro, Carla
AU - Chiumello, Davide
AU - Ciardo, Stefano
AU - Coburn, Mark
AU - Colella, Umberto
AU - Contreras, Victor
AU - Dincer, Pelin Corman
AU - Cotter, Elizabeth
AU - Crovetto, Marcia
AU - Darrah, William
AU - Davies, Simon
AU - De Hert, Stefan
AU - Peces, Enrique Del Cojo
AU - Delphin, Ellise
AU - Diaper, John
AU - Do Nascimento Junior, Paulo
AU - Donatiello, Valerio
AU - Dong, Jing
AU - Dourado, Maria Do Socorro
AU - Dullenkopf, Alexander
AU - Ebner, Felix
AU - Elgendy, Hamed
AU - Ellenberger, Christoph
AU - Erdogan Ari, Dilek
AU - Ermert, Thomas
AU - Farah, Fadi
AU - Fernandez-Bustamante, Ana
AU - Ferreira, Cristina
AU - Fiore, Marco
AU - Fonte, Ana
AU - Palahí, Christina Fortià
AU - Galimberti, Andrea
AU - Garofano, Najia
AU - Giaccari, Luca Gregorio
AU - Gilsanz, Fernando
AU - Girrbach, Felix
AU - Gobbi, Luca
AU - Godfried, Marc Bernard
AU - Goettel, Nicolai
AU - Goldstein, Peter A.
AU - Goren, Or
AU - Gorlin, Andrew
AU - Gil, Manuel Granell
AU - Gratarola, Angelo
AU - Graterol, Juan
AU - Guyon, Pierre
AU - Haire, Kevin
AU - Harou, Philippe
AU - Helf, Antonia
AU - Hempel, Gunther
AU - Cádiz, María José Hernández
AU - Heyse, Björn
AU - Huercio, Ivan
AU - Ilievska, Jasmina
AU - Jakus, Lien
AU - Jeganath, Vijay
AU - Jelting, Yvonne
AU - Jung, Minoa
AU - Kabon, Barbara
AU - Kacha, Aalok
AU - Ilic, Maja Karaman
AU - Karuppiah, Arunthevaraja
AU - Kavas, Ayse Duygu
AU - Barcelos, Gleicy Keli
AU - Kellogg, Todd A.
AU - Kemper, Johann
AU - Kerbrat, Romain
AU - Khodr, Suraya
AU - Kienbaum, Peter
AU - Kir, Bunyamin
AU - Kiss, Thomas
AU - Kivrak, Selin
AU - Klaric, Vlasta
AU - Koch, Thea
AU - Köksal, Ceren
AU - Kowark, Ana
AU - Kranke, Peter
AU - Kuvaki, Bahar
AU - Kuzmanovska, Biljana
AU - Lange, Mirko
AU - de Lemos, Marília Freitas
AU - López-Baamonde, Manuel
AU - López-Hernández, Antonio
AU - Lopez-Martinez, Mercedes
AU - Luise, Stéphane
AU - Macgregor, Mark
AU - Magalhães, Danielle
AU - Maillard, Julien
AU - Malerbi, Patrizia
AU - Manimekalai, Natesan
AU - Margarson, Michael
AU - Martin, Archer K.
AU - Martin, David P.
AU - Martin, Yvette N.
AU - Martínez-Ocon, Julia
AU - Martin-Loeches, Ignacio
AU - Maseda, Emilio
AU - McAuliffe, Niamh
AU - McKenzie, Travis J.
AU - Medina, Paulina
AU - Meersch, Melanie
AU - Menzen, Angelika
AU - Mertens, Els
AU - Meurer, Bernd
AU - Meyer-Treschan, Tanja
AU - Miao, Changhong
AU - Micalizzi, Camilla
AU - Milic, Morena
AU - Módolo, Norma Sueli Pinheiro
AU - Moine, Pierre
AU - Mölders, Patrick
AU - Montero-Feijoo, Ana
AU - Moret, Enrique
AU - Muller, Markus K.
AU - Murphy, Zoe
AU - Nalwaya, Pramod
AU - Naumovski, Filip
AU - Navalesi, Paolo
AU - Navarro E Lima, Lais Helena
AU - Adam, Višnja Nesek
AU - Neumann, Claudia
AU - Newell, Christopher
AU - Nisnevitch, Zoulfira
AU - Nizamuddin, Junaid
AU - Novazzi, Cecilia
AU - O’connor, Michael
AU - Oprea, Günther
AU - Sungur, Mukadder Orhan
AU - Özbilgin, Sule
AU - Pace, Maria Caterina
AU - Pacheco, Marcos
AU - Packianathaswamy, Balaji
AU - Gonzalez, Estefania Palma
AU - Papaspyros, Fotios
AU - Paredes, Sebastián
AU - Passavanti, Maria Beatrice
AU - Pedemonte, Juan Cristobal
AU - Peremin, Sanja
AU - Philipsenburg, Christoph
AU - Pinho, Daniela
AU - Pinho, Silvia
AU - Posthuma, Linda M.
AU - Pota, Vincenzo
AU - Preckel, Benedikt
AU - Priani, Paolo
AU - Rached, Mohamed Aymen
AU - Radoeshki, Aleksandar
AU - Ragazzi, Riccardo
AU - Rajamanickam, Tamilselvan
AU - Rajamohan, Arthi
AU - Ramakrishna, Harish
AU - Rangarajan, Desikan
AU - Reiterer, Christian
AU - Ross Renew, J.
AU - Reynaud, Thomas
AU - Rhys, Rhidian
AU - Rivas, Eva
AU - Robitzky, Luisa
AU - Rubulotta, Francesca
AU - Machado, Humberto S.
AU - Nunes, Catarina S.
AU - Sabbatini, Giovanni
AU - Samuels, Jon D.
AU - Sanahuja, Josep Martí
AU - Sansone, Pasquale
AU - Santos, Alice
AU - Sayedalahl, Mohamed
AU - Schaefer, Maximilian S.
AU - Scharffenberg, Martin
AU - Schiffer, Eduardo
AU - Schliewe, Nadja
AU - Schorer, Raoul
AU - Schumann, Roman
AU - Selmo, Gabriele
AU - Sendra, Mar
AU - Shaw, Kate
AU - Shosholcheva, Mirjana
AU - Sibai, Abdulrazak
AU - Simon, Philipp
AU - Simonassi, Francesca
AU - Sinno, Claudia
AU - Sivrikoz, Nukhet
AU - Skandalou, Vasiliki
AU - Smith, Neil
AU - Soares, Maria
AU - Artiles, Tania Socorro
AU - Castro, Diogo Sousa
AU - Sousa, Miguel
AU - Spadaro, Savino
AU - Stamatakis, Emmanouil
AU - Steiner, Luzius A.
AU - Stevenazzi, Andrea
AU - Suarez-De-la-rica, Alejandro
AU - Suppan, Mélanie
AU - Teichmann, Robert
AU - Guerrero, José Maria Tena
AU - Thiel, Bram
AU - Tolós, Raquel
AU - Altun, Gulbin Tore
AU - Tucci, Michelle
AU - Turnbull, Zachary A.
AU - Turudic, Žana
AU - Unterberg, Matthias
AU - Van Limmen, Jurgen
AU - Van Nieuwenhove, Yves
AU - Van Waesberghe, Julia
AU - Vitkovic, Bibiana
AU - Vivona, Luigi
AU - Vizcaychipi, Marcela
AU - Volta, Carlo Alberto
AU - Weber, Anne
AU - Weingarten, Toby N.
AU - Wittenstein, Jakob
AU - Wyffels, Piet
AU - Yagüe, Julio
AU - Yates, David
AU - Yavru, Aysen
AU - Zac, Lilach
AU - Zhong, Jing
N1 - Funding Information: The Clinical Trials Network of the European Society of Anaesthesiology (ESA) provided a grant to support building and management of the data bank, preparation of the electronic case report forms, as well as promotion of the trial and steering committee meetings. The Department of Anesthesiology and Intensive Care, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany, supported the investigators at the coordination site in Dresden, Germany. The Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq), Brasília, Brazil, partially supported investigators in Brazil (process number 402685/2016-4). Supported in the UK by a grant from the Association of Anaesthetists of Great Britain & Ireland (AAGBI)/ Northern Ireland Society of Anaesthetists (NIAA) awarded to GH Mills. Publisher Copyright: © 2019 American Medical Association. All rights reserved.
PY - 2019/6/18
Y1 - 2019/6/18
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85066479370&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85066479370&partnerID=8YFLogxK
U2 - 10.1001/jama.2019.7505
DO - 10.1001/jama.2019.7505
M3 - Article
C2 - 31157366
AN - SCOPUS:85066479370
SN - 0098-7484
VL - 321
SP - 2292
EP - 2305
JO - JAMA - Journal of the American Medical Association
JF - JAMA - Journal of the American Medical Association
IS - 23
ER -