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
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,
for the PROTHOR investigators,
the Research Workgroup PROtective VEntilation Network (PROVEnet) of the European Society of Anaesthesiology (ESA)
Affiliations
T. Kiss
Department of Anesthesiology and Intensive Care Medicine, Pulmonary Engineering Group, University Hospital Carl Gustav Carus, Technische Universität Dresden
J. Wittenstein
Department of Anesthesiology and Intensive Care Medicine, Pulmonary Engineering Group, University Hospital Carl Gustav Carus, Technische Universität Dresden
C. Becker
Department of Anesthesiology and Intensive Care Medicine, Pulmonary Engineering Group, University Hospital Carl Gustav Carus, Technische Universität Dresden
K. Birr
Department of Anesthesiology and Intensive Care Medicine, Pulmonary Engineering Group, University Hospital Carl Gustav Carus, Technische Universität Dresden
G. Cinnella
Department of Anesthesia and Intensive Care, OO Riuniti Hospital, University of Foggia
E. Cohen
Department of Anesthesiology, The Mount Sinai Hospital
M. R. El Tahan
Imam Abdulrahman Bin Faisal University
L. F. Falcão
Federal University of São Paulo
C. Gregoretti
UOC Anestesia e Rianimazione A.O.Universitaria “P. Giaccone”, Dipartimento Di.Chir.On.S., Università degli Studi di Palermo
M. Granell
Hospital General Universitario de Valencia
T. Hachenberg
University Hospital Magdeburg
M. W. Hollmann
Department of Anesthesiology, Amsterdam UMC, location AMC
R. Jankovic
Clinic for Anesthesia and Intensive Therapy, Clinical Center Nis, School of Medicine, University of Nis
W. Karzai
Zentralklinik Bad Berka
J. Krassler
Thoracic Center Coswig
T. Loop
Department of Anesthesiology and Intensive Care Medicine Clinic, Medical Center, University of Freiburg, Faculty of Medicine, University of Freiburg
M. J. Licker
University Hospital Geneva
N. Marczin
Section of Anaesthetics, Pain Medicine and Intensive Care, Department of Surgery and Cancer, Faculty of Medicine, Imperial College London
G. H. Mills
Department of Anaesthesia and Intensive Care Medicine, Sheffield Teaching Hospitals, Sheffield University
M. T. Murrell
Department of Anesthesiology, Weill Cornell Medicine
V. Neskovic
Military Medical Academy
Z. Nisnevitch-Savarese
Penn State Hershey Anesthesiology & Perioperative Medicine
P. Pelosi
Department of Surgical Sciences and Integrated Diagnostics, University of Genoa
R. Rossaint
Department of Anaesthesiology, University Hospital Aachen
M. J. Schultz
Department of Intensive Care & Laboratory of Experimental Intensive Care and Anesthesiology (L·E·I·C·A), Academic Medical Center, University of Amsterdam
A. Serpa Neto
Department of Critical Care, Hospital Israelita Albert Einstein
P. Severgnini
Dipartimento di Biotecnologie e Scienze della Vita, Università degli Studi dell’Insubria
L. Szegedi
Department of Anesthesiology, Centre Hospitalier Universitaire de Charleroi
T. Vegh
Department of Anesthesiology and Intensive Care, University of Debrecen
G. Voyagis
Department of Anaesthesia, Postoperative ICU, Pain Relief & Palliative Care Clinic, “Sotiria” Chest Diseases Hospital
J. Zhong
Department of Anesthesiology, Fudan University Shanghai Cancer Center
M. Gama de Abreu
Department of Anesthesiology and Intensive Care Medicine, Pulmonary Engineering Group, University Hospital Carl Gustav Carus, Technische Universität Dresden
M. Senturk
Department of Anaesthesiology and Intensive Care, Istanbul University, Istanbul Medical Faculty
for the PROTHOR investigators
the Research Workgroup PROtective VEntilation Network (PROVEnet) of the European Society of Anaesthesiology (ESA)
Abstract 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/m2, 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 cmH2O with lung RM, or PEEP of 5 cmH2O 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 clinicaltrials.gov (NCT02963025) on 15 November 2016.
