Driving pressure during general anesthesia for minimally invasive abdominal surgery --study protocol of a randomized clinical trial

• Published in: Trials 2024, Vol.25 (1)
• Main Authors: Dorland, Galina, Vermeulen, Tom D, Hollmann, Markus W, Schultz, Marcus J, Hol, Liselotte, Nijbroek, Sunny G. L. H, Breel-Tebbutt, Jenni S, Neto, Ary Serpa, Mazzinari, Guido, Gasteiger, Lukas, Ball, Lorenzo, Pelosi, Paolo, Almac, Emre, Navarro, Maria P. Argente, Battaglini, Denise, Besselink, Marc G, Bokkerink, Patty E. M. M, van den Broek, Janneke, Buise, Marc P, Broens, Suzanne, Davidson, ZoÃ, Cambronero, Oscar Díaz, Dejaco, Hannes, Ensink-Tjaberings, Petra Y, Florax, Anna A, de Abreu, Marcelo Gama, Godfried, Marc B, Harmon, Matthew B. A, Helmerhorst, Hendrik J. F, Huhn, Ragnar, Huhle, Robert, Jetten, Wesley D, de Jong, Merijn, Koopman, Joseph S. H. A, Koster, Stephanie C. E, de Korte-de Boer, Dianne J, Kuiper, Geert-Jan A. J. M, Trip, Charlotte N. Laman, Morariu, Aurora M, Nass, Stefan A, Oei, Gezina T. M. L, Pap-Brugmans, Alice C, Paulus, Frederique, Potters, Jan-Willem, Rad, Mandana, Robba, Chiara, Sarton, Elise Y, Servaas, Sjoerd, Smit, Kirsten F, Stamkot, André, Thiel, Bram, Struys, Michel M. R. F, van de Wint, Thijs C, Wittenstein, Jakob, Zeillemaker-Hoekstra, Miriam, van der Zwan, Tim, Hemmes, Sabrine N. T, van Meenen, David M. P, Staier, Nikolai, Mörtl, Maximilian
• Format: Report
• Language: English
• Subjects: Anesthesia; Blood pressure; Clinical trials; Measurement; Medical research; Medicine, Experimental
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/s13063-024-08479-x

Background Intraoperative driving pressure ([DELA]P) has an independent association with the development of postoperative pulmonary complications (PPCs) in patients receiving ventilation during general anesthesia for major surgery. Ventilation with high intraoperative positive end-expiratory pressure (PEEP) with recruitment maneuvers (RMs) that result in a low [DELA]P has the potential to prevent PPCs. This trial tests the hypothesis that compared to standard low PEEP without RMs, an individualized high PEEP strategy, titrated to the lowest [DELA]P, with RMs prevents PPCs in patients receiving intraoperative protective ventilation during anesthesia for minimally invasive abdominal surgery. Methods "DrivinG prEssure duriNg gEneRal AnesThesia fOr minimally invasive abdominal suRgery (GENERATOR)" is an international, multicenter, two-group, patient and outcome-assessor blinded randomized clinical trial. In total, 1806 adult patients scheduled for minimally invasive abdominal surgery and with an increased risk of PPCs based on (i) the ARISCAT risk score for PPCs ([greater than or equal to] 26 points) and/or (ii) a combination of age > 40 years and scheduled surgery lasting > 2 h and planned to receive an intra-arterial catheter for blood pressure monitoring during the surgery will be included. Patients are assigned to either an intraoperative ventilation strategy with individualized high PEEP, titrated to the lowest [DELA]P, with RMs or one with a standard low PEEP of 5 cm H.sub.2O without RMs. The primary outcome is a collapsed composite endpoint of PPCs until postoperative day 5. Discussion GENERATOR will be the first adequately powered randomized clinical trial to compare the effects of individualized high PEEP with RMs versus standard low PEEP without RMs on the occurrence of PPCs after minimally invasive abdominal surgery. The results of the GENERATOR trial will support anesthesiologists in their decisions regarding PEEP settings during minimally invasive abdominal surgery. Trial registration GENERATOR is registered at ClinicalTrials.gov (study identifier: NCT06101511) on 26 October 2023. Keywords: Mechanical ventilation, Intraoperative ventilation, Driving pressure, Positive end - expiratory pressure, Recruitment maneuver, Minimally invasive abdominal surgery, Pulmonary complications, Postoperative complications, Postoperative pulmonary complications