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