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1. 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.

Author

Bluth T, Serpa Neto A, Schultz MJ, Pelosi P, Gama de Abreu M, Bluth T, Bobek I, Canet JC, Cinnella G, de Baerdemaeker L, Gama de Abreu M, Gregoretti C, Hedenstierna G, Hemmes SNT, Hiesmayr M, Hollmann MW, Jaber S, Laffey J, Licker MJ, Markstaller K, Matot I, Mills GH, Mulier JP, Pelosi P, Putensen C, Rossaint R, Schmitt J, Schultz MJ, Senturk M, Serpa Neto A, Severgnini P, Sprung J, Vidal Melo MF, and Wrigge H

Subjects
Adult, Anesthesia, General, Body Mass Index, Female, Humans, Lung Diseases etiology, Male, Middle Aged, Pleural Diseases etiology, Pleural Diseases prevention & control, Pulmonary Atelectasis therapy, Respiratory Insufficiency etiology, Respiratory Insufficiency prevention & control, Tidal Volume, Treatment Outcome, Intraoperative Care, Lung Diseases prevention & control, Obesity complications, Positive-Pressure Respiration methods, Postoperative Complications prevention & control, Surgical Procedures, Operative adverse effects
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.

Published
2019
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2. Protective intraoperative ventilation with higher versus lower levels of positive end-expiratory pressure in obese patients (PROBESE): study protocol for a randomized controlled trial.

Author

Bluth T, Teichmann R, Kiss T, Bobek I, Canet J, Cinnella G, De Baerdemaeker L, Gregoretti C, Hedenstierna G, Hemmes SN, Hiesmayr M, Hollmann MW, Jaber S, Laffey JG, Licker MJ, Markstaller K, Matot I, Müller G, Mills GH, Mulier JP, Putensen C, Rossaint R, Schmitt J, Senturk M, Serpa Neto A, Severgnini P, Sprung J, Vidal Melo MF, Wrigge H, Schultz MJ, Pelosi P, and Gama de Abreu M

Subjects
Body Mass Index, Clinical Protocols, Female, Humans, Intraoperative Care adverse effects, Lung Diseases diagnosis, Lung Diseases etiology, Lung Diseases physiopathology, Male, Obesity diagnosis, Obesity physiopathology, Positive-Pressure Respiration adverse effects, Protective Factors, Research Design, Risk Factors, Time Factors, Treatment Outcome, Anesthesia, General adverse effects, Intraoperative Care methods, Lung physiopathology, Lung Diseases prevention & control, Obesity complications, Positive-Pressure Respiration methods, Surgical Procedures, Operative adverse effects
Abstract

Background: Postoperative pulmonary complications (PPCs) increase the morbidity and mortality of surgery in obese patients. High levels of positive end-expiratory pressure (PEEP) with lung recruitment maneuvers may improve intraoperative respiratory function, but they can also compromise hemodynamics, and the effects on PPCs are uncertain. We hypothesized that intraoperative mechanical ventilation using high PEEP with periodic recruitment maneuvers, as compared with low PEEP without recruitment maneuvers, prevents PPCs in obese patients., Methods/design: The PRotective Ventilation with Higher versus Lower PEEP during General Anesthesia for Surgery in OBESE Patients (PROBESE) study is a multicenter, two-arm, international randomized controlled trial. In total, 2013 obese patients with body mass index ≥35 kg/m 2 scheduled for at least 2 h of surgery under general anesthesia and at intermediate to high risk for PPCs will be included. Patients are ventilated intraoperatively with a low tidal volume of 7 ml/kg (predicted body weight) and randomly assigned to PEEP of 12 cmH 2 O with lung recruitment maneuvers (high PEEP) or PEEP of 4 cmH 2 O without recruitment maneuvers (low PEEP). The occurrence of PPCs will be recorded as collapsed composite of single adverse pulmonary events and represents the primary endpoint., Discussion: To our knowledge, the PROBESE trial is the first multicenter, international randomized controlled trial to compare the effects of two different levels of intraoperative PEEP during protective low tidal volume ventilation on PPCs in obese patients. The results of the PROBESE trial will support anesthesiologists in their decision to choose a certain PEEP level during general anesthesia for surgery in obese patients in an attempt to prevent PPCs., Trial Registration: ClinicalTrials.gov identifier: NCT02148692. Registered on 23 May 2014; last updated 7 June 2016.

Published
2017
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3. 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

Author

Bluth, T, Neto, As, Schultz, Mj, Pelosi, P, de Abreu MG, Bobek, I, Canet, Jc, de Baerdemaeker, L, Gregoretti, C, Hedenstierna, G, Hemmes, Snt, Hiesmayr, M, Hollmann, M, Jaber, S, Laffey, J, Licker, Mj, Markstaller, K, Matot, I, Mills, G, Mulier, Jp, Putensen, C, Rossaint, R, Schmitt, J, Senturk, M, Severgnini, P, Sprung, J, Melo, Mfv, Wrigge, H, Abelha, F, Abitagaoglu, S, Achilles, M, Adebesin, A, Adriaensens, I, Ahene, C, Akbar, F, Al Harbi, M, al Kallab RA, Albanel, X, Aldenkortt, F, Alfouzan, Ras, Alruqaie, R, Altermatt, F, Araujo, Bld, Arbesu, G, Artsi, H, Aurilio, C, Ayanoglu, Oh, Bacuzzi, A, Baig, H, Baird, Y, Balonov, K, Balust, J, Banks, S, Bao, Xd, Baumgartner, M, Tortosa, Ib, Bergamaschi, A, Bergmann, L, Bigatello, L, Perez, Eb, Birr, K, Bojaxhi, E, Bonenti, C, Bonney, I, Bos, Ee, Bowman, S, Braz, Lg, Brugnoni, E, Brunetti, I, Bruni, A, Buenvenida, Sl, Camerini, Cj, Canet, J, Capatti, B, Carmona, J, Carungcong, J, Carvalho, M, Cattan, A, Cavaleiro, C, Chiumello, D, Ciardo, S, Coburn, M, Colella, U, Contreras, V, Dincer, Pc, Cotter, E, Crovetto, M, Crovetto, W, Darrah, W, Davies, S, De Hert, S, Peces, Ed, Delphin, E, Diaper, J, do Nascimento, P, Donatiello, V, Dong, J, Dourado, Md, Dullenkopf, A, Ebner, F, Elgendy, H, Ellenberger, C, Ari, De, Ermert, T, Farah, F, Fernandez-Bustamante, A, Ferreira, C, Fiore, M, Fonte, A, Palahi, Cf, Galimberti, A, Garofano, N, Giaccari, Lg, Gilsanz, F, Girrbach, F, Gobbi, L, Godfried, Mb, Goettel, N, Goldstein, Pa, Goren, O, Gorlin, A, Gil, Mg, Gratarola, A, Graterol, J, Guyon, P, Haire, K, Harou, P, Helf, A, Hempel, G, Cadiz, Mjh, Heyse, B, Hollmann, Mw, Huercio, I, Ilievska, J, Jakus, L, Jeganath, V, Jelting, Y, Jung, M, Kabon, B, Kacha, A, Ilic, Mk, Karuppiah, A, Kavas, Ad, Barcelos, Gk, Kellogg, Ta, Kemper, J, Kerbrat, R, Khodr, S, Kienbaum, P, Kir, B, Kiss, T, Kivrak, S, Klaric, V, Koch, T, Koksal, C, Kowark, A, Kranke, P, Kuvaki, B, Kuzmanovska, B, Lange, M, de Lemos MF, Lopez-Baamonde, M, Lopez-Hernandez, A, Lopez-Martinez, M, Luise, S, Macgregor, M, Magalhaes, D, Maillard, J, Malerbi, P, Manimekalai, N, Margarson, M, Martin, Dp, Martin, Yn, Martinez-Ocon, J, Martin-Loeches, I, Maseda, E, Mcauliffe, N, Mckenzie, Tj, Medina, P, Meersch, M, Menzen, A, Mertens, E, Meurer, B, Meyer-Treschan, T, Miao, Ch, Micalizzi, C, Milic, M, Modolo, Nsp, Moine, P, Molders, P, Montero-Feijoo, A, Moret, E, Muller, Mk, Murphy, Z, Nalwaya, P, Naumovski, F, Navalesi, P, Lima, Lhne, Adam, Vn, Neumann, C, Newell, C, Nisnevitch, Z, Nizamuddin, J, Novazzi, C, O'Connor, M, Oprea, G, Sungur, Mo, Ozbilgin, S, Pace, Mc, Pacheco, M, Packianathaswamy, B, Gonzalez, Ep, Papaspyros, F, Paredes, S, Passavanti, Mb, Pedemonte, Jc, Peremin, S, Philipsenburg, C, Pinho, D, Pinho, S, Posthuma, Lm, Pota, V, Preckel, B, Priani, P, Rached, Ma, Radoeshki, A, Ragazzi, R, Rajamanickam, T, Rajamohan, A, Ramakrishna, H, Rangarajan, D, Reiterer, C, Renew, Jr, Reynaud, T, Rhys, R, Rivas, E, Robitzky, L, Rubulotta, F, Machado, Hs, Nunes, Cs, Sabbatini, G, Sanahuja, Jm, Sansone, P, Santos, A, Sayedalahl, M, Schaefer, Ms, Scharffenberg, E, Scharffenberg, M, Schiffer, E, Schliewe, N, Schorer, R, Schumann, R, Selmo, G, Sendra, M, Shaw, K, Shosholcheva, M, Sibai, A, Simon, P, Simonassi, F, Sinno, C, Sivrikoz, N, Skandalou, V, Smith, N, Soares, M, Artiles, Ts, Castro, Ds, Sousa, M, Spadaro, S, Stamatakis, E, Steiner, La, Stevenazzi, A, Suarez-de-la-Rica, A, Suppan, M, Teichmann, R, Guerrero, Jmt, Thiel, B, Tolos, R, Altun, Gt, Tucci, M, Turnbull, Za, Turudic, Z, Unterberg, M, Van Limmen, J, Van Nieuwenhove, Y, Van Waesberghe, J, Francisco, M, Melo, V, Vitkovic, B, Vivona, L, Vizcaychipi, M, Volta, Ca, Weber, A, Weingarten, Tn, Wittenstein, J, Wyffels, P, Yague, J, Yates, D, Yavru, A, Zac, L, Zhong, J, Intensive Care Medicine, ACS - Heart failure & arrhythmias, Anesthesiology, ACS - Diabetes & metabolism, APH - Quality of Care, ACS - Pulmonary hypertension & thrombosis, ACS - Microcirculation, Bluth T., Serpa Neto A., Schultz M.J., Pelosi P., Gama de Abreu M., Bobek I., Canet J.C., Cinella G., de Baerdemaeker L., Gregoretti C., Hedenstierna G., Hemmes S.N.T., Hiesmayr M., Hollmann M.W., Jaber S., Laffey J., Licker M.-J., Markstaller K., Matot I., Mills G.H., Mulier J.P., Putensen C., Rossaint R., Schmitt J., Senturk M., Severgnini P., Sprung J., Vidal Melo M.F., Wrigge H., Abelha F., Abitagaoglu S., Achilles M., Adebesin A., Adriaensens I., Ahene C., Akbar F., Harbi M.A., Al Kallab R.A.K., Albanel X., Aldenkortt F., Alfouzan R.A.S., Alruqaie R., Altermatt F., de Castro Araujo B.L., Arbesu G., Artsi H., Aurilio C., Ayanoglu O.H., Bacuzzi A., Baig H., Baird Y., Balonov K., Balust J., Banks S., Bao X., Baumgartner M., Tortosa I.B., Bergamaschi A., Bergmann L., Bigatello L., Perez E.B., Birr K., Bojaxhi E., Bonenti C., Bonney I., Bos E.M.E., Bowman S., Braz L.G., Brugnoni E., Brull S.J., Brunetti I., Bruni A., Buenvenida S.L., Busch C.J., Camerini G., Capatti B., Carmona J., Carungcong J., Carvalho M., Cattan A., Cavaleiro C., Chiumello D., Ciardo S., Coburn M., Colella U., Contreras V., Dincer P.C., Cotter E., Crovetto M., Darrah W., Davies S., De Hert S., Peces E.D.C., Delphin E., Diaper J., Do Nascimento Junior P., Donatiello V., Dong J., Dourado M.D.S., Dullenkopf A., Ebner F., Elgendy H., Ellenberger C., Erdogan Ari D., Ermert T., Farah F., Fernandez-Bustamante A., Ferreira C., Fiore M., Fonte A., Palahi C.F., Galimberti A., Garofano N., Giaccari L.G., Gilsanz F., Girrbach F., Gobbi L., Godfried M.B., Goettel N., Goldstein P.A., Goren O., Gorlin A., Gil M.G., Gratarola A., Graterol J., Guyon P., Haire K., Harou P., Helf A., Hempel G., Cadiz M.J.H., Heyse B., Huercio I., Ilievska J., Jakus L., Jeganath V., Jelting Y., Jung M., Kabon B., Kacha A., Ilic M.K., Karuppiah A., Kavas A.D., Barcelos G.K., Kellogg T.A., Kemper J., Kerbrat R., Khodr S., Kienbaum P., Kir B., Kiss T., Kivrak S., Klaric V., Koch T., Koksal C., Kowark A., Kranke P., Kuvaki B., Kuzmanovska B., Lange M., de Lemos M.F., Lopez-Baamonde M., Lopez-Hernandez A., Lopez-Martinez M., Luise S., Macgregor M., Magalhaes D., Maillard J., Malerbi P., Manimekalai N., Margarson M., Martin A.K., Martin D.P., Martin Y.N., Martinez-Ocon J., Martin-Loeches I., Maseda E., McAuliffe N., McKenzie T.J., Medina P., Meersch M., Menzen A., Mertens E., Meurer B., Meyer-Treschan T., Miao C., Micalizzi C., Milic M., Modolo N.S.P., Moine P., Molders P., Montero-Feijoo A., Moret E., Muller M.K., Murphy Z., Nalwaya P., Naumovski F., Navalesi P., Navarro E Lima L.H., Adam V.N., Neumann C., Newell C., Nisnevitch Z., Nizamuddin J., Novazzi C., O'connor M., Oprea G., Sungur M.O., Ozbilgin S., Pace M.C., Pacheco M., Packianathaswamy B., Gonzalez E.P., Papaspyros F., Paredes S., Passavanti M.B., Pedemonte J.C., Peremin S., Philipsenburg C., Pinho D., Pinho S., Posthuma L.M., Pota V., Preckel B., Priani P., Rached M.A., Radoeshki A., Ragazzi R., Rajamanickam T., Rajamohan A., Ramakrishna H., Rangarajan D., Reiterer C., Ross Renew J., Reynaud T., Rhys R., Rivas E., Robitzky L., Rubulotta F., Machado H.S., Nunes C.S., Sabbatini G., Samuels J.D., Sanahuja J.M., Sansone P., Santos A., Sayedalahl M., Schaefer M.S., Scharffenberg M., Schiffer E., Schliewe N., Schorer R., Schumann R., Selmo G., Sendra M., Shaw K., Shosholcheva M., Sibai A., Simon P., Simonassi F., Sinno C., Sivrikoz N., Skandalou V., Smith N., Soares M., Artiles T.S., Castro D.S., Sousa M., Spadaro S., Stamatakis E., Steiner L.A., Stevenazzi A., Suarez-De-la-rica A., Suppan M., Teichmann R., Guerrero J.M.T., Thiel B., Tolos R., Altun G.T., Tucci M., Turnbull Z.A., Turudic Z., Unterberg M., Van Limmen J., Van Nieuwenhove Y., Van Waesberghe J., Vitkovic B., Vivona L., Vizcaychipi M., Volta C.A., Weber A., Weingarten T.N., Wittenstein J., Wyffels P., Yague J., Yates D., Yavru A., Zac L., Zhong J., Bluth, T., Serpa Neto, A., Schultz, M. J., Pelosi, P., Gama De Abreu, M., Aurilio, C., Pace, M. C., Passavanti, M. B., Pota, V., and Sansone, P.

Subjects
Lung Diseases, Male, medicine.medical_treatment, Atelectasis, Lung Disease, 01 natural sciences, Body Mass Index, Hypoxemia, Positive-Pressure Respiration, Postoperative Complications, 0302 clinical medicine, PEEP, postoperative complications, obese patients, Anesthesia, Respiratory function, 030212 general & internal medicine, Tidal volume, General Medicine, Middle Aged, Pleural Diseases, respiratory system, Adult, Anesthesia, General, Female, Humans, Obesity, Pulmonary Atelectasis, Respiratory Insufficiency, Surgical Procedures, Operative, Tidal Volume, Treatment Outcome, Intraoperative Care, Operative, 3. Good health, Pneumothorax, medicine.symptom, psychological phenomena and processes, Human, circulatory and respiratory physiology, NO, 03 medical and health sciences, mental disorders, medicine, Pleural Disease, 0101 mathematics, General, Positive end-expiratory pressure, Mechanical ventilation, Surgical Procedures, Pulmonary Atelectasi, business.industry, 010102 general mathematics, medicine.disease, respiratory tract diseases, Respiratory failure, Postoperative Complication, business
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

Published
2019

4. Protective intraoperative ventilation with higher versus lower levels of positive end-expiratory pressure in obese patients (PROBESE): study protocol for a randomized controlled trial

Author

Bluth, T., Teichmann, R., Hiesmayr, M., Socorro, Tania, Izquierdo, Ana, Soro, Marina, Granell Gil, Manuel, Hernández Cádiz, María José, Biosca Pérez, Elena, Suarez-de-la-Rica, Alejandro, Lopez-Martinez, Mercedes, Huercio, Iván, Maseda, Emilio, Hollmann, M. W., Yagüe, Julio, Cebrian Moreno, Alba, Rivas, Eva, Lopez-Baamonde, Manuel, Elgendy, Hamed, Sayedalahl, Mohamed, SIibai, Abdul Razak, Yavru, Aysen, Sivrikoz, Nukhet, Karadeniz, Meltem, Jaber, S., Corman Dincer, Pelin, Ayanoglu, Hilmi Omer, Tore Altun, Gulbin, Kavas, Ayse Duygu, Dinc, Bora, Kuvaki, Bahar, Ozbilgin, Sule, Erdogan, Dilek, Koksal, Ceren, Abitagaglu, Suheyla, Laffey, J. G., Aurilio, Caterina, Sansone, Pasquale, Pace, Caterina Maria, Donatiello, Valerio, Mattera, Silvana, Nazareno, Palange, Di Colandrea, Salvatore, Spadaro, Savino, Volta, Carlo Alberto, Ragazzi, Riccardo, Licker, M. J., Ciardo, Stefano, Gobbi, Luca, Severgnini, Paolo, Bacuzzi, Alessandro, Brugnoni, Elisa, Gratarola, Angelo, Micalizzi, Camilla, Simonassi, Francesca, Malerbi, Patrizia, Carboni, Adrea, Markstaller, K., Licker, Marc-Joseph, Dullenkopf, Alexander, Goettel, Nicolai, Nesek Adam, Visnja, Karaman Ilic, Maja, Klaric, Vlasta, Vitkovic, Bibiana, Milic, Morena, Zupcic, Miro, De Baerdemaeker, Luc, Matot, I., De Hert, Stefan, Heyse, Bjorn, Van Limmen, Jurgen, Van Nieuwenhove, Yves, Mertens, Els, Neyrinck, Arne, Mulier, Jan, Kahn, David, Godoroja, Daniela, Martin-Loeches, Martin, Müller, G., Vorotyntsev, Sergiy, Fronchko, Valentyna, Matot, Idit, Goren, Or, Zac, Lilach, Gaszynski, Thomasz, Laffey, Jon, Mills, Gary, Nalwaya, Pramod, Mac Gregor, Mark, Mills, G. H., Paddle, Jonathan, Balaji, Packianathaswamy, Rubulotta, Francesca, Adebesin, Afeez, Margarson, Mike, Davies, Simon, Rangarajan, Desikan, Newell, Christopher, Shosholcheva, Mirjana, Papaspyros, Fotios, Mulier, J. P., Skandalou, Vasiliki, Dzurnakov, Paula, Kiss, T., Putensen, C., Rossaint, Rolf, Schmitt, J., Senturk, M., Serpa Neto, A., Severgnini, P., Sprung, J., Vidal Melo, M. F., Wrigge, H., Schultz, M. J., Bobek, I., Pelosi, P., Gama de Abreu, M., PROBESE investigators, PROtective VEntilation Network (PROVEnet), Clinical Trial Network of the European Society of Anaesthesiology (ESA), Güldner, Andreas, Huhle, Robert, Uhlig, Christopher, Vivona, Luigi, Bergamaschi, Alice, Canet, J., Stevanovic, Ana, Treschan, Tanja, Schaefer, Maximilian, Kienbaum, Peter, Laufenberg-Feldmann, Rita, Bergmann, Lars, Ebner, Felix, Robitzky, Luisa, Mölders, Patrick, Cinnella, G., Unterberg, Matthias, Busch, Cornelius, Achilles, Marc, Menzen, Angelika, Freesemann, Harbert, Putensen, Christian, Machado, Humberto, Cavaleiro, Carla, Ferreira, Cristina, Pinho, Daniela, De Baerdemaeker, L., Carvalho, Marta, Pinho, Sílvia, Soares, Maria, Castro, Diogo Sousa, Abelha, Fernando, Rabico, Rui, Delphin, Ellise, Sprung, Juraj, Weingarten, Toby N., Kellogg, Todd A., Gregoretti, C., Martin, Yvette N., McKenzie, Travis J., Brull, Sorin J., Renew, J. Ross, Ramakrishna, Harish, Fernandez-Bustamante, Ana, Balonov, Konstantin, Baig, Harris R., Kacha, Aalok, Pedemonte, Juan C., Hedenstierna, G., Altermatt, Fernando, Corvetto, Marcia A., Paredes, Sebastian, Carmona, Javiera, Rolle, Augusto, Bos, Elke, Beurskens, Charlotte, Veering, B., Zonneveldt, Harry, Boer, Christa, Hemmes, S. N., Godfried, Marc, Thiel, Bram, Kabon, Barbara, Reiterer, Christian, Canet, Jaume, Tolós, Raquel, Sendra, Mar, González, Miriam, Gómez, Noemí, Ferrando, Carlos, Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Bluth T., Teichmann R., Kiss T., Bobek I., Canet J., Cinnella G., De Baerdemaeker L., Gregoretti C., Hedenstierna G., Hemmes S.N., Hiesmayr M., Hollmann M.W., Jaber S., Laffey J.G., Licker M.J., Markstaller K., Matot I., Muller G., Mills G.H., Mulier J.P., Putensen C., Rossaint R., Schmitt J., Senturk M., Serpa Neto A., Severgnini P., Sprung J., Vidal Melo M.F., Wrigge H., Schultz M.J., Pelosi P., Gama de Abreu M., Guldner A., Huhle R., Uhlig C., Vivona L., Bergamaschi A., Stevanovic A., Treschan T., Schaefer M., Kienbaum P., Laufenberg-Feldmann R., Bergmann L., Ebner F., Robitzky L., Molders P., Unterberg M., Busch C., Achilles M., Menzen A., Freesemann H., Machado H., Cavaleiro C., Ferreira C.P., Pinho D., Carvalho M., Pinho S., Soares M., Castro D.S., Abelha F., Rabico R., Delphin E., Weingarten T.N., Kellogg T.A., Martin Y.N., McKenzie T.J., Brull S.J., Renew J.R., Ramakrishna H., Fernandez-Bustamante A., Balonov K., Baig H.R., Kacha A., Pedemonte J.C., Altermatt F., Corvetto M.A., Paredes S., Carmona J., Rolle A., Bos E., Beurskens C., Veering B., Zonneveldt H., Boer C., Godfried M., Thiel B., Kabon B., Reiterer C., Tolos R., Sendra M., Gonzalez M., Gomez N., Ferrando C., Socorro T., Izquierdo A., Soro M., Granell Gil M., Hernandez Cadiz M.J., Biosca Perez E., Suarez-de-la-Rica A., Lopez-Martinez M., Huercio I., Maseda E., Yague J., Cebrian Moreno A., Rivas E., Lopez-Baamonde M., Elgendy H., Sibai A.R., Yavru A., Sivrikoz N., Karadeniz M., Corman Dincer P., Ayanoglu H., Tore Altun G., Kavas A.D., Dinc B., Kuvaki B., Ozbilgin S., Erdogan D., Koksal C., Abitagaglu S., Aurilio C., Sansone P., Pace C.M., Donatiello V., Mattera S., Palange N., Di Colandrea S., Spadaro S., Volta C.A., Ragazzi R., Ciardo S., Gobbi L., Bacuzzi A., Brugnoni E., Gratarola A., Micalizzi C., Simonassi F., Malerbi P., Carboni A., Dullenkopf A., Goettel N., Nesek Adam V., Karaman Ilic M., Klaric V., Vitkovic B., Milic M., Miro Z., De Hert S., Heyse B., Van Limmen J., Van Nieuwenhove Y., Mertens E., Kahn D., Godoroja D., Martin-Loeches M., Vorotyntsev S., Fronchko V., Goren O., Zac L., Gaszynski T., Nalwaya P., Mac Gregor M., Paddle J., Balaji P., Rubulotta F., Adebesin A., Margarson M., Davies S., Rangarajan D., Newell C., Shosholcheva M., Papaspyros F., Skandalou V., Dzurnakova P., Anesthesiology, ACS - Heart failure & arrhythmias, AII - Inflammatory diseases, Intensive Care Medicine, ACS - Diabetes & metabolism, ACS - Pulmonary hypertension & thrombosis, ACS - Microcirculation, UCL - (SLuc) Département de médecine aiguë, UCL - (SLuc) Service d'anesthésiologie, Bluth, T, Teichmann, R, Kiss, T, Bobek, I, Canet, J, Cinnella, G, De Baerdemaeker, L, Gregoretti, C, Hedenstierna, G, Hemmes, S N, Hiesmayr, M, Hollmann, M W, Jaber, S, Laffey, J G, Licker, M J, Markstaller, K, Matot, I, Müller, G, Mills, G H, Mulier, J P, Putensen, C, Rossaint, R, Schmitt, J, Senturk, M, Serpa Neto, A, Severgnini, P, Sprung, J, Vidal Melo, M F, Wrigge, H, Schultz, M J, Pelosi, P, Gama de Abreu, M, Güldner, A, Huhle, R, Uhlig, C, Vivona, L, Bergamaschi, A, Stevanovic, A, Treschan, T, Schaefer, M, Kienbaum, P, Laufenberg-Feldmann, R, Bergmann, L, Ebner, F, Robitzky, L, Mölders, P, Unterberg, M, Busch, C, Achilles, M, Menzen, A, Freesemann, H, Machado, H, Cavaleiro, C, Ferreira, C, Pinho, D, Carvalho, M, Pinho, S, Soares, M, Castro, D, Abelha, F, Rabico, R, Delphin, E, Weingarten, Tn, Kellogg, Ta, Martin, Yn, Mckenzie, Tj, Brull, Sj, Renew, Jr, Ramakrishna, H, Fernandez-Bustamante, A, Balonov, K, Baig, Hr, Kacha, A, Pedemonte, Jc, Altermatt, F, Corvetto, Ma, Paredes, S, Carmona, J, Rolle, A, Bos, E, Beurskens, C, Veering, B, Zonneveldt, H, Boer, C, Godfried, M, Thiel, B, Kabon, B, Reiterer, C, Tolós, R, Sendra, M, González, M, Gómez, N, Ferrando, C, Socorro, T, Izquierdo, A, Soro, M, Granell Gil, M, Hernández Cádiz, Mj, Biosca Pérez, E, Suarez-de-la-Rica, A, Lopez-Martinez, M, Huercio, I, Maseda, E, Yagüe, J, Cebrian Moreno, A, Rivas, E, Lopez-Baamonde, M, Elgendy, H, Sayedalahl, M, Siibai, Ar, Yavru, A, Sivrikoz, N, Karadeniz, M, Corman Dincer, P, Ayanoglu, Ho, Tore Altun, G, Kavas, Ad, Dinc, B, Kuvaki, B, Ozbilgin, S, Erdogan, D, Koksal, C, Abitagaglu, S, Aurilio, C, Sansone, P, Pace, Mc, Donatiello, V, Mattera, S, Nazareno, P, Di Colandrea, S, Spadaro, Antonino, Volta, Ca, Ragazzi, R, Ciardo, S, Gobbi, L, Bacuzzi, A, Brugnoni, E, Gratarola, A, Micalizzi, C, Simonassi, F, Malerbi, P, Carboni, A, Licker, Mj, Dullenkopf, A, Goettel, N, Nesek Adam, V, Karaman Ilić, M, Klaric, V, Vitkovic, B, Milic, M, Zupcic, M, De Hert, S, Heyse, B, Van Limmen, J, Van Nieuwenhove, Y, Mertens, E, Neyrinck, A, Mulier, J, Kahn, D, Godoroja, D, Martin-Loeches, M, Vorotyntsev, S, Fronchko, V, Goren, O, Zac, L, Gaszynski, T, Laffey, J, Mills, G, Nalwaya, P, Mac Gregor, M, Paddle, J, Balaji, P, Rubulotta, F, Adebesin, A, Margarson, M, Davies, S, Rangarajan, D, Newell, C, Shosholcheva, M, Papaspyros, F, Skandalou, V, and Dzurňáková, P.

Subjects
Male, Lung Diseases, Time Factors, [SDV]Life Sciences [q-bio], Respiratory Medicine and Allergy, medicine.medical_treatment, RESPIRATORY-DISTRESS-SYNDROME, Medicine (miscellaneous), Hemodynamics, Mechanical ventilation, Obesity, Positive end-expiratory pressure, Postoperative pulmonary complication, Recruitment maneuver, Pharmacology (medical), LAPAROSCOPIC BARIATRIC SURGERY, Lung Disease, Body Mass Index, law.invention, Positive-Pressure Respiration, Study Protocol, 0302 clinical medicine, Clinical Protocols, Randomized controlled trial, Risk Factors, 030202 anesthesiology, law, Medicine and Health Sciences, Clinical endpoint, Anesthesia, Respiratory function, 030212 general & internal medicine, Lung, Lungmedicin och allergi, 2. Zero hunger, lcsh:R5-920, ddc:617, respiratory system, Operative, 3. Good health, Treatment Outcome, TIDAL VOLUMES, Research Design, Mechanical ventilation, Positive end-expiratory pressure, Recruitment maneuver, Obesity, Postoperative pulmonary complication, Surgical Procedures, Operative, Breathing, Female, Erratum, lcsh:Medicine (General), ALVEOLAR RECRUITMENT MANEUVER, Human, circulatory and respiratory physiology, medicine.medical_specialty, Time Factor, Anesthesia, General, Lung injury, Humans, Intraoperative Care, Protective Factors, NO, GENERAL-ANESTHESIA, DRIVING PRESSURE, 03 medical and health sciences, medicine, ddc:610, Clinical Protocol, General, Protective Factor, POSTOPERATIVE PULMONARY COMPLICATIONS, Surgical Procedures, INTERNATIONAL CONSENSUS, business.industry, Risk Factor, Surgery, respiratory tract diseases, business, LUNG INJURY
Abstract

Background Postoperative pulmonary complications (PPCs) increase the morbidity and mortality of surgery in obese patients. High levels of positive end-expiratory pressure (PEEP) with lung recruitment maneuvers may improve intraoperative respiratory function, but they can also compromise hemodynamics, and the effects on PPCs are uncertain. We hypothesized that intraoperative mechanical ventilation using high PEEP with periodic recruitment maneuvers, as compared with low PEEP without recruitment maneuvers, prevents PPCs in obese patients. Methods/design The PRotective Ventilation with Higher versus Lower PEEP during General Anesthesia for Surgery in OBESE Patients (PROBESE) study is a multicenter, two-arm, international randomized controlled trial. In total, 2013 obese patients with body mass index ≥35 kg/m2 scheduled for at least 2 h of surgery under general anesthesia and at intermediate to high risk for PPCs will be included. Patients are ventilated intraoperatively with a low tidal volume of 7 ml/kg (predicted body weight) and randomly assigned to PEEP of 12 cmH2O with lung recruitment maneuvers (high PEEP) or PEEP of 4 cmH2O without recruitment maneuvers (low PEEP). The occurrence of PPCs will be recorded as collapsed composite of single adverse pulmonary events and represents the primary endpoint. Discussion To our knowledge, the PROBESE trial is the first multicenter, international randomized controlled trial to compare the effects of two different levels of intraoperative PEEP during protective low tidal volume ventilation on PPCs in obese patients. The results of the PROBESE trial will support anesthesiologists in their decision to choose a certain PEEP level during general anesthesia for surgery in obese patients in an attempt to prevent PPCs. Trial registration ClinicalTrials.gov identifier: NCT02148692. Registered on 23 May 2014; last updated 7 June 2016. Electronic supplementary material The online version of this article (doi:10.1186/s13063-017-1929-0) contains supplementary material, which is available to authorized users.

Published
2017

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