Driving Pressure During General Anesthesia for Open Abdominal Surgery (DESIGNATION): study protocol of a randomized clinical trial

BACKGROUND: Intraoperative 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. 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 ≥ 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. 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

Een preoperatieve hypo- en hypernatriëmie is gerelateerd aan verhoogde postoperatieve morbiditeit en mortaliteit: Kijk preoperatief naar het natrium!

Een hypo- of hypernatriëmie komt regelmatig voor bij patiënten voor een operatie. Zeker aangezien het aantal patiënten met hoge leeftijd, polyfarmacie en comorbiditeit toeneemt als gevolg van de vergrijzing van de bevolking. Maar is een afwijkend preoperatief natriumgehalte gerelateerd aan verhoogde postoperatieve mortaliteit en morbiditeit? Om dit te onderzoeken voerden wij een systematische zoekstrategie uit en includeerden zestien artikelen. Het percentage patiënten met een preoperatieve hyponatriëmie bij electieve chirurgie varieert van 2% tot 27% en bij een preoperatieve hypernatriemie van 2% tot 6%. Bij een preoperatieve hyponatriëmie vonden zeven studies (64%) een verhoogd risico op postoperatieve mortaliteit en vier (80%) op morbiditeit. Bij een preoperatieve hypernatriëmie vonden zes studies (100%) een verhoogd risico op postoperatieve mortaliteit en drie (67%) op morbiditeit. Een afwijkend preoperatief natriumgehalte is dus gerelateerd aan verhoogde postoperatieve morbiditeit en mortaliteit. Als anesthesioloog is het belangrijk om hier aandacht voor te hebben. Indien het preoperatieve natriumgehalte afwijkend is en er voldoende tijd is, kunt u overwegen om dit te corrigeren alvorens de operatie plaatsvindt

Driving Pressure During General Anesthesia for Open Abdominal Surgery (DESIGNATION): study protocol of a randomized clinical trial

Background Intraoperative driving pressure (Delta P) is associated with development of postoperative pulmonary complications (PPC). When tidal volume (V-T) is kept constant, Delta P may change according to positive end-expiratory pressure (PEEP)-induced changes in lung aeration. Delta 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 >= 18 years and with a body mass index <= 40 kg/m(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 H2O without RM is used ("low PEEP"). In the "individualized high PEEP" group, PEEP is set at the level at which Delta P is lowest. In both groups of the trial, V-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