Driving pressure during general anesthesia for minimally invasive abdominal surgery (GENERATOR)-study protocol of a randomized clinical trial.
Humans
Anesthesia, General
/ adverse effects
Abdomen
/ surgery
Positive-Pressure Respiration
/ methods
Randomized Controlled Trials as Topic
Minimally Invasive Surgical Procedures
Multicenter Studies as Topic
Postoperative Complications
/ prevention & control
Treatment Outcome
Lung Diseases
/ prevention & control
Time Factors
Driving pressure
Intraoperative ventilation
Mechanical ventilation
Minimally invasive abdominal surgery
Positive end − expiratory pressure
Postoperative complications
Postoperative pulmonary complications
Pulmonary complications
Recruitment maneuver
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
26 Oct 2024
26 Oct 2024
Historique:
received:
26
11
2023
accepted:
17
09
2024
medline:
26
10
2024
pubmed:
26
10
2024
entrez:
26
10
2024
Statut:
epublish
Résumé
Intraoperative driving pressure (ΔP) has an independent association with the development of postoperative pulmonary complications (PPCs) in patients receiving ventilation during general anesthesia for major surgery. Ventilation with high intraoperative positive end-expiratory pressure (PEEP) with recruitment maneuvers (RMs) that result in a low ΔP has the potential to prevent PPCs. This trial tests the hypothesis that compared to standard low PEEP without RMs, an individualized high PEEP strategy, titrated to the lowest ΔP, with RMs prevents PPCs in patients receiving intraoperative protective ventilation during anesthesia for minimally invasive abdominal surgery. "DrivinG prEssure duriNg gEneRal AnesThesia fOr minimally invasive abdominal suRgery (GENERATOR)" is an international, multicenter, two-group, patient and outcome-assessor blinded randomized clinical trial. In total, 1806 adult patients scheduled for minimally invasive abdominal surgery and with an increased risk of PPCs based on (i) the ARISCAT risk score for PPCs (≥ 26 points) and/or (ii) a combination of age > 40 years and scheduled surgery lasting > 2 h and planned to receive an intra-arterial catheter for blood pressure monitoring during the surgery will be included. Patients are assigned to either an intraoperative ventilation strategy with individualized high PEEP, titrated to the lowest ΔP, with RMs or one with a standard low PEEP of 5 cm H GENERATOR will be the first adequately powered randomized clinical trial to compare the effects of individualized high PEEP with RMs versus standard low PEEP without RMs on the occurrence of PPCs after minimally invasive abdominal surgery. The results of the GENERATOR trial will support anesthesiologists in their decisions regarding PEEP settings during minimally invasive abdominal surgery. GENERATOR is registered at ClinicalTrials.gov (study identifier: NCT06101511) on 26 October 2023.
Sections du résumé
BACKGROUND
BACKGROUND
Intraoperative driving pressure (ΔP) has an independent association with the development of postoperative pulmonary complications (PPCs) in patients receiving ventilation during general anesthesia for major surgery. Ventilation with high intraoperative positive end-expiratory pressure (PEEP) with recruitment maneuvers (RMs) that result in a low ΔP has the potential to prevent PPCs. This trial tests the hypothesis that compared to standard low PEEP without RMs, an individualized high PEEP strategy, titrated to the lowest ΔP, with RMs prevents PPCs in patients receiving intraoperative protective ventilation during anesthesia for minimally invasive abdominal surgery.
METHODS
METHODS
"DrivinG prEssure duriNg gEneRal AnesThesia fOr minimally invasive abdominal suRgery (GENERATOR)" is an international, multicenter, two-group, patient and outcome-assessor blinded randomized clinical trial. In total, 1806 adult patients scheduled for minimally invasive abdominal surgery and with an increased risk of PPCs based on (i) the ARISCAT risk score for PPCs (≥ 26 points) and/or (ii) a combination of age > 40 years and scheduled surgery lasting > 2 h and planned to receive an intra-arterial catheter for blood pressure monitoring during the surgery will be included. Patients are assigned to either an intraoperative ventilation strategy with individualized high PEEP, titrated to the lowest ΔP, with RMs or one with a standard low PEEP of 5 cm H
DISCUSSION
CONCLUSIONS
GENERATOR will be the first adequately powered randomized clinical trial to compare the effects of individualized high PEEP with RMs versus standard low PEEP without RMs on the occurrence of PPCs after minimally invasive abdominal surgery. The results of the GENERATOR trial will support anesthesiologists in their decisions regarding PEEP settings during minimally invasive abdominal surgery.
TRIAL REGISTRATION
BACKGROUND
GENERATOR is registered at ClinicalTrials.gov (study identifier: NCT06101511) on 26 October 2023.
Identifiants
pubmed: 39456048
doi: 10.1186/s13063-024-08479-x
pii: 10.1186/s13063-024-08479-x
doi:
Banques de données
ClinicalTrials.gov
['NCT06101511']
Types de publication
Journal Article
Clinical Trial Protocol
Langues
eng
Sous-ensembles de citation
IM
Pagination
719Investigateurs
Galina Dorland
(G)
Tom D Vermeulen
(TD)
Markus W Hollmann
(MW)
Marcus J Schultz
(MJ)
Liselotte Hol
(L)
Sunny G L H Nijbroek
(SGLH)
Jenni S Breel-Tebbutt
(JS)
Ary Serpa Neto
(AS)
Guido Mazzinari
(G)
Lukas Gasteiger
(L)
Lorenzo Ball
(L)
Paolo Pelosi
(P)
Emre Almac
(E)
Maria P Argente Navarro
(MPA)
Denise Battaglini
(D)
Marc G Besselink
(MG)
Patty E M M Bokkerink
(PEMM)
Janneke van den Broek
(J)
Marc P Buise
(MP)
Suzanne Broens
(S)
Zoë Davidson
(Z)
Oscar Díaz Cambronero
(OD)
Hannes Dejaco
(H)
Petra Y Ensink-Tjaberings
(PY)
Anna A Florax
(AA)
Marcelo Gama de Abreu
(MG)
Marc B Godfried
(MB)
Matthew B A Harmon
(MBA)
Hendrik J F Helmerhorst
(HJF)
Ragnar Huhn
(R)
Robert Huhle
(R)
Wesley D Jetten
(WD)
Merijn de Jong
(M)
Joseph S H A Koopman
(JSHA)
Stephanie C E Koster
(SCE)
Dianne J de Korte-de Boer
(DJ)
Geert-Jan A J M Kuiper
(GAJM)
Charlotte N Laman Trip
(CNL)
Aurora M Morariu
(AM)
Stefan A Nass
(SA)
Gezina T M L Oei
(GTML)
Alice C Pap Brugmans
(AC)
Frederique Paulus
(F)
Jan-Willem Potters
(JW)
Mandana Rad
(M)
Chiara Robba
(C)
Elise Y Sarton
(EY)
Sjoerd Servaas
(S)
Kirsten F Smit
(KF)
André Stamkot
(A)
Bram Thiel
(B)
Michel M R F Struys
(MMRF)
Thijs C van de Wint
(TC)
Jakob Wittenstein
(J)
Miriam Zeillemaker-Hoekstra
(M)
Tim van der Zwan
(T)
Sabrine N T Hemmes
(SNT)
David M P van Meenen
(DMP)
Nikolai Staier
(N)
Maximilian Mörtl
(M)
Informations de copyright
© 2024. The Author(s).
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