Standard

Driving Pressure during General Anesthesia for Open Abdominal Surgery (DESIGNATION): Study protocol of a randomized clinical trial. / Hol, Liselotte; Nijbroek, Sunny G. L. H.; Neto, Ary Serpa et al.

In: Trials, Vol. 21, No. 1, 198, 18.02.2020.

Research output: Contribution to journal › Article › Academic › peer-review

Harvard

Hol, L, Nijbroek, SGLH, Neto, AS, de Abreu, MG, Pelosi, P, Hemmes, SNT, Aarts, LPHJ, Akkerman, RDL, Albersen, JJE, Aurilio, C, Battaglini, D, de Boer, HD, Boom, A, Boer, C, Brouwer, T, Buhre, WFFA, Bulte, CSE, Edward-Rutten, GM, Godfried, MB, Helmerhorst, HJF, Hofland, J, Hoogenboom, H, ten Hoope, W, Houweling, BM, Huhn, R, Konijn, W, Koopman-van Gemert, AWMM, de Korte-de Boer, DJ, Kortekaas, MC, van Lier, F, Preckel, B, Rad, M, Sansone, P, Stamkot, A, Stolker, RJ, Thiel, B, Ubben, JFH, Struys, MMRF, in 't Veld, BA, Wrigge, H, Zeillemaker-Hoekstra, M, van der Zwan, T, Zwijsen, JHMJ, Hollmann, MW & Schultz, MJ 2020, 'Driving Pressure during General Anesthesia for Open Abdominal Surgery (DESIGNATION): Study protocol of a randomized clinical trial', Trials, vol. 21, no. 1, 198. https://doi.org/10.1186/s13063-020-4075-z

APA

Hol, L., Nijbroek, S. G. L. H., Neto, A. S., de Abreu, M. G., Pelosi, P., Hemmes, S. N. T., Aarts, L. P. H. J., Akkerman, R. D. L., Albersen, J. J. E., Aurilio, C., Battaglini, D., de Boer, H. D., Boom, A., Boer, C., Brouwer, T., Buhre, W. F. F. A., Bulte, C. S. E., Edward-Rutten, G. M., Godfried, M. B., ... Schultz, M. J. (2020). Driving Pressure during General Anesthesia for Open Abdominal Surgery (DESIGNATION): Study protocol of a randomized clinical trial. Trials, 21(1), [198]. https://doi.org/10.1186/s13063-020-4075-z

Vancouver

Hol L, Nijbroek SGLH, Neto AS, de Abreu MG, Pelosi P, Hemmes SNT et al. Driving Pressure during General Anesthesia for Open Abdominal Surgery (DESIGNATION): Study protocol of a randomized clinical trial. Trials. 2020 Feb 18;21(1):198. doi: 10.1186/s13063-020-4075-z

Author

Hol, Liselotte ; Nijbroek, Sunny G. L. H. ; Neto, Ary Serpa et al. / Driving Pressure during General Anesthesia for Open Abdominal Surgery (DESIGNATION): Study protocol of a randomized clinical trial. In: Trials. 2020 ; Vol. 21, No. 1.

BibTeX

@article{dae4bcd7da714662902ca11729b3d6fc,
title = "Driving Pressure during General Anesthesia for Open Abdominal Surgery (DESIGNATION): Study protocol of a randomized clinical trial",
abstract = "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.",
keywords = "Compliance, Intraoperative ventilation, Mechanical ventilation, Positive end-expiratory pressure, Postoperative complications, Postoperative pulmonary complications, Pulmonary complications, Recruitment maneuver, ΔP",
author = "Liselotte Hol and Nijbroek, {Sunny G. L. H.} and Neto, {Ary Serpa} and {de Abreu}, {Marcelo Gama} and Paolo Pelosi and Hemmes, {Sabrine N. T.} and Aarts, {Leon P. H. J.} and Akkerman, {Ronald D. L.} and Albersen, {Juliette J. E.} and Caterina Aurilio and Denise Battaglini and {de Boer}, {Hans D.} and Annemieke Boom and Christa Boer and Tammo Brouwer and Buhre, {Wolfgang F. F. A.} and Bulte, {Carolina S. E.} and Edward-Rutten, {Gitara M.} and Godfried, {Marc B.} and Helmerhorst, {Hendrik J. F.} and Jan Hofland and Hester Hoogenboom and {ten Hoope}, W. and Houweling, {Bernard M.} and Ragnar Huhn and Wanda Konijn and {Koopman-van Gemert}, {Ankie W. M. M.} and {de Korte-de Boer}, {Dianne J.} and Kortekaas, {Minke C.} and {van Lier}, Felix and Benedikt Preckel and Mandana Rad and Pasquale Sansone and Andr{\'e} Stamkot and Stolker, {Robert Jan} and Bram Thiel and Ubben, {Johannes F. H.} and Struys, {Michel M. R. F.} and {in 't Veld}, {Bastiaan A.} and Hermann Wrigge and Miriam Zeillemaker-Hoekstra and {van der Zwan}, Tim and Zwijsen, {Johannes H. M. J.} and Hollmann, {Markus W.} and Schultz, {Marcus J.}",
year = "2020",
month = feb,
day = "18",
doi = "10.1186/s13063-020-4075-z",
language = "English",
volume = "21",
journal = "Trials",
issn = "1745-6215",
publisher = "BioMed Central",
number = "1",

}

RIS

TY - JOUR

T1 - Driving Pressure during General Anesthesia for Open Abdominal Surgery (DESIGNATION): Study protocol of a randomized clinical trial

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 - Bulte, Carolina S. E.

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=85079772630&partnerID=8YFLogxK

U2 - 10.1186/s13063-020-4075-z

DO - 10.1186/s13063-020-4075-z

M3 - Article

C2 - 32070400

VL - 21

JO - Trials

JF - Trials

SN - 1745-6215

IS - 1

M1 - 198

ER -

ID: 11073442