학술논문
Driving Pressure During General Anesthesia for Open Abdominal Surgery (DESIGNATION): study protocol of a randomized clinical trial
Document Type
Clinical report
Author
Hol, Liselotte; Nijbroek, Sunny G. L. H.; Neto, Ary Serpa; de Abreu, Marcelo Gama; Pelosi, Paolo; Hemmes, Sabrine N. T.; Aarts, Leon P. H. J.; Akkerman, Ronald D. L.; Albersen, Juliette J. E.; Aurilio, Caterina; Battaglini, Denise; de Boer, Hans D.; Boom, Annemieke; Boer, Christa; Brouwer, Tammo; Buhre, Wolfgang F. F. A.; Bulte, Carolina S. E.; Edward-Rutten, Gitara M.; Godfried, Marc B.; Helmerhorst, Hendrik J. F.; Hofland, Jan; Hoogenboom, Hester; Ten Hoope, W.; Houweling, Bernard M.; Huhn, Ragnar; Konijn, Wanda; Koopman-van Gemert, Ankie W. M. M.; de Korte-de Boer, Dianne J.; Kortekaas, Minke C.; van Lier, Felix; Preckel, Benedikt; Rad, Mandana; Sansone, Pasquale; Stamkot, André; Stolker, Robert Jan; Thiel, Bram; Ubben, Johannes F. H.; Struys, Michel M. R. F.; in 't Veld, Bastiaan A.; Wrigge, Hermann; Zeillemaker-Hoekstra, Miriam; van der Zwan, Tim; Zwijsen, Johannes H. M. J.; Hollmann, Markus W.; Schultz, Marcus J.
Source
Trials. February 18, 2020, Vol. 21 Issue 1
Subject
Language
English
ISSN
1745-6215
Abstract
Author(s): Liselotte Hol[sup.1], Sunny G. L. H. Nijbroek, Ary Serpa Neto, Marcelo Gama de Abreu, Paolo Pelosi, Sabrine N. T. Hemmes, Leon P. H. J. Aarts, Ronald D. L. Akkerman, [...]
Background Intraoperative driving pressure ([DELA]P) is associated with development of postoperative pulmonary complications (PPC). When tidal volume (V.sub.T) is kept constant, [DELA]P may change according to positive end-expiratory pressure (PEEP)-induced changes in lung aeration. [DELA]P may decrease if PEEP leads to a recruitment of collapsed lung tissue but will increase if PEEP mainly causes pulmonary overdistension. This study tests the hypothesis that individualized high PEEP, when compared to fixed low PEEP, protects against PPC in patients undergoing open abdominal surgery. Methods The 'Driving prESsure durIng GeNeral AnesThesIa for Open abdomiNal surgery trial' (DESIGNATION) is an international, multicenter, two-group, double-blind randomized clinical superiority trial. A total of 1468 patients will be randomly assigned to one of the two intraoperative ventilation strategies. Investigators screen patients aged [greater than or equai to] 18 years and with a body mass index [less than or equai to] 40 kg/m.sup.2, scheduled for open abdominal surgery and at risk for PPC. Patients either receive an intraoperative ventilation strategy with individualized high PEEP with recruitment maneuvers (RM) ('individualized high PEEP') or one in which PEEP of 5 cm H.sub.2O without RM is used ('low PEEP'). In the 'individualized high PEEP' group, PEEP is set at the level at which [DELA]P is lowest. In both groups of the trial, V.sub.T is kept at 8 mL/kg predicted body weight. The primary endpoint is the occurrence of PPC, recorded as a collapsed composite of adverse pulmonary events. Discussion DESIGNATION will be the first randomized clinical trial that is adequately powered to compare the effects of individualized high PEEP with RM versus fixed low PEEP without RM on the occurrence of PPC after open abdominal surgery. The results of DESIGNATION will support anesthesiologists in their decisions regarding PEEP settings during open abdominal surgery. Trial registration Clinicaltrials.gov, NCT03884543. Registered on 21 March 2019. Keywords: Mechanical ventilation, Intraoperative ventilation, [DELA]P, Compliance, Positive end-expiratory pressure, Recruitment maneuver , Pulmonary complications, Postoperative complications, Postoperative pulmonary complications
Background Intraoperative driving pressure ([DELA]P) is associated with development of postoperative pulmonary complications (PPC). When tidal volume (V.sub.T) is kept constant, [DELA]P may change according to positive end-expiratory pressure (PEEP)-induced changes in lung aeration. [DELA]P may decrease if PEEP leads to a recruitment of collapsed lung tissue but will increase if PEEP mainly causes pulmonary overdistension. This study tests the hypothesis that individualized high PEEP, when compared to fixed low PEEP, protects against PPC in patients undergoing open abdominal surgery. Methods The 'Driving prESsure durIng GeNeral AnesThesIa for Open abdomiNal surgery trial' (DESIGNATION) is an international, multicenter, two-group, double-blind randomized clinical superiority trial. A total of 1468 patients will be randomly assigned to one of the two intraoperative ventilation strategies. Investigators screen patients aged [greater than or equai to] 18 years and with a body mass index [less than or equai to] 40 kg/m.sup.2, scheduled for open abdominal surgery and at risk for PPC. Patients either receive an intraoperative ventilation strategy with individualized high PEEP with recruitment maneuvers (RM) ('individualized high PEEP') or one in which PEEP of 5 cm H.sub.2O without RM is used ('low PEEP'). In the 'individualized high PEEP' group, PEEP is set at the level at which [DELA]P is lowest. In both groups of the trial, V.sub.T is kept at 8 mL/kg predicted body weight. The primary endpoint is the occurrence of PPC, recorded as a collapsed composite of adverse pulmonary events. Discussion DESIGNATION will be the first randomized clinical trial that is adequately powered to compare the effects of individualized high PEEP with RM versus fixed low PEEP without RM on the occurrence of PPC after open abdominal surgery. The results of DESIGNATION will support anesthesiologists in their decisions regarding PEEP settings during open abdominal surgery. Trial registration Clinicaltrials.gov, NCT03884543. Registered on 21 March 2019. Keywords: Mechanical ventilation, Intraoperative ventilation, [DELA]P, Compliance, Positive end-expiratory pressure, Recruitment maneuver , Pulmonary complications, Postoperative complications, Postoperative pulmonary complications