Abstract
BackgroundIntraoperative driving pressure (ΔP) is associated with development of postoperative pulmonary complications (PPC). When tidal volume (VT) is kept constant, ΔP may change according to positive end-expiratory pressure (PEEP)-induced changes in lung aeration. ΔP 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.MethodsThe “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 ≥ 18 years and with a body mass index ≤ 40 kg/m2, 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 H2O without RM is used (“low PEEP”). In the “individualized high PEEP” group, PEEP is set at the level at which ΔP is lowest. In both groups of the trial, VT 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.DiscussionDESIGNATION 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 registrationClinicaltrials.gov, NCT03884543. Registered on 21 March 2019.
Highlights
Intraoperative driving pressure (ΔP) is associated with development of postoperative pulmonary complications (PPC)
The aim of the “Driving prESsure durIng GeNeral AnesThesIa for Open abdomiNal surgery trial” (DESIGNATION) is to compare intraoperative ventilation with individualized high positive end-expiratory pressure (PEEP) and recruitment maneuvers (RM) versus ventilation with a fixed low PEEP without RM in patients planned for open abdominal surgery with respect to the development of PPC
DESIGNATION tests the premise that, in patients planned for open abdominal surgery and at risk for PPC, an individualized high PEEP strategy that aims at reducing atelectasis but preventing overdistension better protects against the development of PPC than a strategy that uses a fixed high PEEP
Summary
Objectives and design DESIGNATION is an international, multicenter, prospective, two-group, double-blind RCT in patients planned for open abdominal surgery and at risk of developing PPC. DESIGNATION tests the premise that, in patients planned for open abdominal surgery and at risk for PPC, an individualized high PEEP strategy that aims at reducing atelectasis but preventing overdistension better protects against the development of PPC than a strategy that uses a fixed high PEEP. Study population Local investigators screen patients aged ≥ 18 years with a maximum body mass index (BMI) of 40 kg/m2 planned for open abdominal surgery. Inspiratory to expiratory ratio (I:E) is set at 1:2 and the respiratory rate is adjusted to allow for Interventions Patients assigned to the “individualized high PEEP” group undergo a RM before and after the “decremental PEEP trial,” after any disconnection from the ventilator and within 1 h before extubation. RM are only performed after assuring a stable hemodynamic situation, as
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