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.

Protective intraoperative ventilation with higher versus lower levels of positive end-expiratory pressure in obese patients (PROBESE) : Study protocol for a randomized controlled trial / T. Bluth, R. Teichmann, T. Kiss, I. Bobek, J. Canet, G. Cinnella, L. De Baerdemaeker, C. Gregoretti, G. Hedenstierna, S.N. Hemmes, M. Hiesmayr, M.W. Hollmann, S. Jaber, J.G. Laffey, M.J. Licker, K. Markstaller, I. Matot, G. Muller, G.H. Mills, J.P. Mulier, C. Putensen, R. Rossaint, J. Schmitt, M. Senturk, A. Serpa Neto, P. Severgnini, J. Sprung, M.F. Vidal Melo, H. Wrigge, M.J. Schultz, P. Pelosi, M. Gama de Abreu, A. Guldner, R. Huhle, C. Uhlig, L. Vivona, A. Bergamaschi, A. Stevanovic, T. Treschan, M. Schaefer, P. Kienbaum, R. Laufenberg-Feldmann, L. Bergmann, F. Ebner, L. Robitzky, P. Molders, M. Unterberg, C. Busch, M. Achilles, A. Menzen, H. Freesemann, H. Machado, C. Cavaleiro, C.P. Ferreira, D. Pinho, M. Carvalho, S. Pinho, M. Soares, D.S. Castro, F. Abelha, R. Rabico, E. Delphin, T.N. Weingarten, T.A. Kellogg, Y.N. Martin, T.J. McKenzie, S.J. Brull, J.R. Renew, H. Ramakrishna, A. Fernandez-Bustamante, K. Balonov, H.R. Baig, A. Kacha, J.C. Pedemonte, F. Altermatt, M.A. Corvetto, S. Paredes, J. Carmona, A. Rolle, E. Bos, C. Beurskens, B. Veering, H. Zonneveldt, C. Boer, M. Godfried, B. Thiel, B. Kabon, C. Reiterer, R. Tolos, M. Sendra, M. Gonzalez, N. Gomez, C. Ferrando, T. Socorro, A. Izquierdo, M. Soro, M. Granell Gil, M.J. Hernandez Cadiz, E. Biosca Perez, A. Suarez-de-la-Rica, M. Lopez-Martinez, I. Huercio, E. Maseda, J. Yague, A. Cebrian Moreno, E. Rivas, M. Lopez-Baamonde, H. Elgendy, A.R. Sibai, A. Yavru, N. Sivrikoz, M. Karadeniz, P. Corman Dincer, H. Ayanoglu, G. Tore Altun, A.D. Kavas, B. Dinc, B. Kuvaki, S. Ozbilgin, D. Erdogan, C. Koksal, S. Abitagaglu, C. Aurilio, P. Sansone, C.M. Pace, V. Donatiello, S. Mattera, N. Palange, S. Di Colandrea, S. Spadaro, C.A. Volta, R. Ragazzi, S. Ciardo, L. Gobbi, A. Bacuzzi, E. Brugnoni, A. Gratarola, C. Micalizzi, F. Simonassi, P. Malerbi, A. Carboni, A. Dullenkopf, N. Goettel, V. Nesek Adam, M. Karaman Ilic, V. Klaric, B. Vitkovic, M. Milic, Z. Miro, S. De Hert, B. Heyse, J. Van Limmen, Y. Van Nieuwenhove, E. Mertens, D. Kahn, D. Godoroja, M. Martin-Loeches, S. Vorotyntsev, V. Fronchko, O. Goren, L. Zac, T. Gaszynski, P. Nalwaya, M. Mac Gregor, J. Paddle, P. Balaji, F. Rubulotta, A. Adebesin, M. Margarson, S. Davies, D. Rangarajan, C. Newell, M. Shosholcheva, F. Papaspyros, V. Skandalou, P. Dzurnakova. - In: TRIALS. - ISSN 1745-6215. - 18:1(2017 Apr 28), pp. 202.1-202.22. [10.1186/s13063-017-1929-0]

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

L. Vivona;
2017

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.
Mechanical ventilation; Obesity; Positive end-expiratory pressure; Postoperative pulmonary complication; Recruitment maneuver; Body Mass Index; Clinical Protocols; Female; Humans; Intraoperative Care; Lung; Lung Diseases; Male; Obesity; Positive-Pressure Respiration; Protective Factors; Research Design; Risk Factors; Time Factors; Treatment Outcome; Anesthesia, General; Surgical Procedures, Operative
Settore MED/41 - Anestesiologia
Article (author)
File in questo prodotto:
File Dimensione Formato  
2017_Trials_s13063-017-1929-0.pdf

accesso aperto

Tipologia: Publisher's version/PDF
Dimensione 1.02 MB
Formato Adobe PDF
1.02 MB Adobe PDF Visualizza/Apri
Pubblicazioni consigliate

I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.

Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/2434/857143
Citazioni
  • ???jsp.display-item.citation.pmc??? 16
  • Scopus 33
  • ???jsp.display-item.citation.isi??? 32
social impact