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Title: Protective ventilation with high versus low positive end-expiratory pressure during one-lung ventilation for thoracic surgery (PROTHOR): Study protocol for a randomized controlled trial
Authors: T. Kiss
J. Wittenstein
C. Becker
K. Birr
G. Cinnella
E. Cohen
M. R. El Tahan
L. F. Falcão
C. Gregoretti
M. Granell
T. Hachenberg
M. W. Hollmann
R. Jankovic
W. Karzai
J. Krassler
T. Loop
M. J. Licker
N. Marczin
G. H. Mills
M. T. Murrell
V. Neskovic
Z. Nisnevitch-Savarese
P. Pelosi
R. Rossaint
M. J. Schultz
A. Serpa Neto
P. Severgnini
L. Szegedi
T. Vegh
G. Voyagis
J. Zhong
M. Gama De Abreu
M. Senturk
Fudan University Shanghai Cancer Center
Ospedale Policlinico San Martino
Imam Abdulrahman Bin Faisal university
Medizinische Fakultät und Uniklinikum Magdeburg
University of Niš
Vojnomedicinska Akademija
Centre Hospitalier Universitaire de Charleroi
Panepistimion Patron
Sotiria General Hospital
Dresden University Faculty of Medicine and University Hospital Carl Gustav Carus
Universität Freiburg im Breisgau
Università degli Studi di Genova
Harefield Hospital
Semmelweis Egyetem
Università degli Studi di Foggia
Zentralklinik Bad Berka
Università degli Studi di Palermo
Hospital Israelita Albert Einstein
Imperial College London
Universidade Federal de Sao Paulo
Hospital General Universitario de Valencia
Mahidol University
Istanbul Üniversitesi Tıp Fakültesi
Hôpitaux universitaires de Genève
Fudan University
Università degli Studi dell'Insubria
The Mount Sinai Hospital
Debreceni Egyetem
Universiteit van Amsterdam
University of Sheffield
Amsterdam UMC - University of Amsterdam
Uniklinik RWTH Aachen
Thoracic Center Coswig
Penn State Hershey
Outcomes Research Consortium
Weill Cornell Medicine
Keywords: Medicine
Issue Date: 11-Apr-2019
Citation: Trials. Vol.20, No.1 (2019)
Abstract: © 2019 The Author(s). Background: Postoperative pulmonary complications (PPC) may result in longer duration of in-hospital stay and even mortality. Both thoracic surgery and intraoperative mechanical ventilation settings add considerably to the risk of PPC. It is unclear if one-lung ventilation (OLV) for thoracic surgery with a strategy of intraoperative high positive end-expiratory pressure (PEEP) and recruitment maneuvers (RM) reduces PPC, compared to low PEEP without RM. Methods: PROTHOR is an international, multicenter, randomized, controlled, assessor-blinded, two-arm trial initiated by investigators of the PROtective VEntilation NETwork. In total, 2378 patients will be randomly assigned to one of two different intraoperative mechanical ventilation strategies. Investigators screen patients aged 18 years or older, scheduled for open thoracic or video-assisted thoracoscopic surgery under general anesthesia requiring OLV, with a maximal body mass index of 35 kg/m 2 , and a planned duration of surgery of more than 60 min. Further, the expected duration of OLV shall be longer than two-lung ventilation, and lung separation is planned with a double lumen tube. Patients will be randomly assigned to PEEP of 10 cmH 2 O with lung RM, or PEEP of 5 cmH 2 O without RM. During two-lung ventilation tidal volume is set at 7 mL/kg predicted body weight and, during OLV, it will be decreased to 5 mL/kg. The occurrence of PPC will be recorded as a collapsed composite of single adverse pulmonary events and represents the primary endpoint. Discussion: PROTHOR is the first randomized controlled trial in patients undergoing thoracic surgery with OLV that is adequately powered to compare the effects of intraoperative high PEEP with RM versus low PEEP without RM on PPC. The results of the PROTHOR trial will support anesthesiologists in their decision to set intraoperative PEEP during protective ventilation for OLV in thoracic surgery. Trial registration: The trial was registered in (NCT02963025) on 15 November 2016.
ISSN: 17456215
Appears in Collections:Scopus 2019

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