TY - JOUR
T1 - Driving Pressure During General Anesthesia for Open Abdominal Surgery (DESIGNATION)
T2 - study protocol of a randomized clinical trial
AU - DESIGNATION–investigators
AU - Bulte, CSE
AU - Hol, Liselotte
AU - Nijbroek, Sunny G. L. H.
AU - Neto, Ary Serpa
AU - de Abreu, Marcelo Gama
AU - Pelosi, Paolo
AU - Hemmes, Sabrine N. T.
AU - Aarts, Leon P. H. J.
AU - Akkerman, Ronald D. L.
AU - Albersen, Juliette J. E.
AU - Aurilio, Caterina
AU - Battaglini, Denise
AU - de Boer, Hans D.
AU - Boom, Annemieke
AU - Boer, Christa
AU - Brouwer, Tammo
AU - Buhre, Wolfgang F. F. A.
AU - Edward-Rutten, Gitara M.
AU - Godfried, Marc B.
AU - Helmerhorst, Hendrik J. F.
AU - Hofland, Jan
AU - Hoogenboom, Hester
AU - ten Hoope, W.
AU - Houweling, Bernard M.
AU - Huhn, Ragnar
AU - Konijn, Wanda
AU - Koopman-van Gemert, Ankie W. M. M.
AU - de Korte-de Boer, Dianne J.
AU - Kortekaas, Minke C.
AU - van Lier, Felix
AU - Preckel, Benedikt
AU - Rad, Mandana
AU - Sansone, Pasquale
AU - Stamkot, André
AU - Stolker, Robert Jan
AU - Thiel, Bram
AU - Ubben, Johannes F. H.
AU - Struys, Michel M. R. F.
AU - in 't Veld, Bastiaan A.
AU - Wrigge, Hermann
AU - Zeillemaker-Hoekstra, Miriam
AU - van der Zwan, Tim
AU - Zwijsen, Johannes H. M. J.
AU - Hollmann, Markus W.
AU - Schultz, Marcus J.
PY - 2020/2/18
Y1 - 2020/2/18
N2 - 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.
AB - 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.
KW - Compliance
KW - Intraoperative ventilation
KW - Mechanical ventilation
KW - Positive end-expiratory pressure
KW - Postoperative complications
KW - Postoperative pulmonary complications
KW - Pulmonary complications
KW - Recruitment maneuver
KW - ΔP
UR - http://www.scopus.com/inward/record.url?scp=85079757330&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/record.url?scp=85079772630&partnerID=8YFLogxK
U2 - https://doi.org/10.1186/s13063-020-4075-z
DO - https://doi.org/10.1186/s13063-020-4075-z
M3 - Article
C2 - 32070400
SN - 1745-6215
VL - 21
SP - 198
JO - Trials
JF - Trials
IS - 1
M1 - 198
ER -