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© The Author(s). 2019. corrected publication 2019. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.

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.

Details

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
Author
Kiss, T. 1   VIAFID ORCID Logo  ; Wittenstein, J. 1 ; Becker, C. 1 ; Birr, K. 1 ; Cinnella, G. 2 ; Cohen, E. 3 ; El Tahan, M. R. 4 ; Falcão, L. F. 5 ; Gregoretti, C. 6 ; Granell, M. 7 ; Hachenberg, T. 8 ; Hollmann, M. W. 9 ; Jankovic, R. 10 ; Karzai, W. 11 ; Krassler, J. 12 ; Loop, T. 13 ; Licker, M. J. 14 ; Marczin, N. 15 ; Mills, G. H. 16 ; Murrell, M. T. 17 ; Neskovic, V. 18 ; Nisnevitch-Savarese, Z. 19 ; Pelosi, P. 20 ; Rossaint, R. 21 ; Schultz, M. J. 22 ; Serpa Neto, A. 23 ; Severgnini, P. 24 ; Szegedi, L. 25 ; Vegh, T. 26 ; Voyagis, G. 27 ; Zhong, J. 28 ; Gama de Abreu, M. 29 ; Senturk, M. 30 ; Neskovic, Vojislava; Radovic, Nevena; Rondovic, Goran; Stamenkovic, Dusica; Vukovic, Rade; Zeba, Snjezana; Rossaint, Rolf; Coburn, Mark; Kowark, Ana; Ziemann, Sebastian; van Waesberghe, Julia; Bauer, Wolfgang; Terwindt, Lotte; Kostopanagiotou, Kostas; Kostroglou, Andreas; Kyttari, Katerina; Sidiropoulou, Tatiana; Jiménez Andújar, María-José; López-Baamonde, Manuel; Navarro Ripoll, Ricard; Rivera Vallejo, Lorena; Henry, Matthew; Jegarl, Anita; Murrell, Matthew; O’Hara, Patrick; Steinkamp, Michele; Kraßler, Jens; Schäfer, Susanne; Becker, Charlotte; Birr, Katja; Bluth, Thomas; Gama de Abreu, Marcelo; Hattenhauer, Sara; Kiss, Thomas; Scharffenberg, Martin; Teichmann, Robert; Wittenstein, Jakob; Vitali, Costanza; Spadaro, Savino; Volta, Carlo Alberto; Ragazzi, Riccardo; Mariano, Karim; Mirabella, Lucia; Mollica, Giuseppina; Montrano, Luigi; Loop, Torsten; Semmelmann, Axel; Wirth, Steffen; Miao, Changhong; Zhong, Jing; Lv, Hu; Wang, Hui; Zhang, Xue; Zhang, Yue; Pelosi, Paolo; Corsi, Laura; Partroniti, Nicolò; Mandelli, Maura; Bonatti, Giulia; Simonassi, Francesca; Gratarola, Angelo; Rodriguez Ruiz, Juan José; Socorro, Tania; Christofaki, Maria; Nyktari, Vasileia; Papaioannou, Alexandra; Şentürk, Nüzhet Mert; Bingul, Emre; Orhan Sungur, Mukadder; Sungur, Zerrin; Heidegger, Manuel; Dossow, Vera; Jerichow, Wiebke; Kammerer, Tobias; Richter, Julia; Schuba, Barbara; Speck, Eike; Stierle, Anna-Lisa; Bruthans, Jan; Matek, Jan; Michálek, Pavel; Didden, Loes; Hofland, Jan; Kuut, Marieke; Mourisse, Jo; Aragon, Sonsoles; Esturi, Rafael; Miñana, Encarna; Sanchez, Fernando; Sfikas, Elaine; Kapezanos, Athanasios; Papamichail, Konstantinos; Toufektzian, Levon; Voyagis, Gregorios; Granell Gil, Manuel; Vergara Sánchez, Asunción; De Andres, José; Morales Sarabia, Javier; Broseta Lleó, Ana; Hernández Laforet, Javier; Murcia Anaya, Mercedes; Pereira Matalobos, Denis; Aguirre Puig, Pilar; Špiček Macan, Jasna; Karadza, Vjekoslav; Kolaric, Nevenka; Andjelković, Lea; Drnovšek Globokar, Mojca; Gorjup, Kristina; Mavko, Ana; Pirc, Dejan; Genoveva, Cadar; Istrate, Raluca; Stoica, Radu; Corneci, Dan; Tanase, Narcis Valentin; Radmilo, Jankovic; Cvetanovic, Vladan; Dinic, Vesna; Grbesa, Tijana; Jovic, Katarina; Nikolic, Aleksandar; Stojanovic, Milena; Veselinovic, Ines; Vukovic, Anita; Wappler, Frank; Defosse, Jerome Michel; Wehmeier, Stefanie; Ermert, Thomas; Wempe, Carola; Wenk, Manuel; Ion, Daniela Iolanda; Ionescu, Cristian; Schilling, Thomas; Macharadze, Tamar; Li, Pei-Ching; Chang, Yi-Ting; Noto, Alberto; Calì, Placido; Desalvo, Giovanni; Deluca, Raffaele; Giofre, Nicola

 University Hospital Carl Gustav Carus, Technische Universität Dresden, Department of Anesthesiology and Intensive Care Medicine, Pulmonary Engineering Group, Dresden, Germany 
 OO Riuniti Hospital, University of Foggia, Department of Anesthesia and Intensive Care, Foggia, Italy (GRID:grid.10796.39) (ISNI:0000000121049995) 
 The Mount Sinai Hospital, Department of Anesthesiology, New York, USA (GRID:grid.416167.3) 
 Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia (GRID:grid.411975.f) (ISNI:0000 0004 0607 035X) 
 Federal University of São Paulo, Sao Paulo, Brazil (GRID:grid.411249.b) (ISNI:0000 0001 0514 7202) 
 UOC Anestesia e Rianimazione A.O.Universitaria “P. Giaccone”, Dipartimento Di.Chir.On.S., Università degli Studi di Palermo, Palermo, Italy (GRID:grid.10776.37) (ISNI:0000 0004 1762 5517) 
 Hospital General Universitario de Valencia, Valencia, Spain (GRID:grid.106023.6) (ISNI:0000 0004 1770 977X) 
 University Hospital Magdeburg, Magdeburg, Germany (GRID:grid.411559.d) (ISNI:0000 0000 9592 4695) 
 Amsterdam UMC, location AMC, Department of Anesthesiology, Amsterdam, The Netherlands (GRID:grid.411559.d) 
10  University of Nis, Clinic for Anesthesia and Intensive Therapy, Clinical Center Nis, School of Medicine, Nis, Serbia (GRID:grid.11374.30) (ISNI:0000 0001 0942 1176) 
11  Zentralklinik Bad Berka, Bad Berka, Germany (GRID:grid.470036.6) (ISNI:0000 0004 0493 5225) 
12  Thoracic Center Coswig, Coswig, Germany (GRID:grid.470036.6) 
13  University of Freiburg, Faculty of Medicine, University of Freiburg, Department of Anesthesiology and Intensive Care Medicine Clinic, Medical Center, Freiburg, Germany (GRID:grid.5963.9) 
14  University Hospital Geneva, Geneva, Switzerland (GRID:grid.150338.c) (ISNI:0000 0001 0721 9812) 
15  Imperial College London, Section of Anaesthetics, Pain Medicine and Intensive Care, Department of Surgery and Cancer, Faculty of Medicine, London, UK (GRID:grid.7445.2) (ISNI:0000 0001 2113 8111); Harefield Hospital, Department of Anaesthesia, Royal Brompton and Harefield NHS Foundation Trust, Middlesex, UK (GRID:grid.413676.1) (ISNI:0000 0000 8683 5797); Semmelweis University, Centre of Anaesthesia and Intensive Care, Budapest, Hungary (GRID:grid.11804.3c) (ISNI:0000 0001 0942 9821) 
16  Sheffield Teaching Hospitals, Sheffield University, Department of Anaesthesia and Intensive Care Medicine, Sheffield, UK (GRID:grid.11835.3e) (ISNI:0000 0004 1936 9262) 
17  Weill Cornell Medicine, Department of Anesthesiology, New York, USA (GRID:grid.5386.8) (ISNI:000000041936877X) 
18  Military Medical Academy, Belgrade, Serbia (GRID:grid.415615.2) 
19  Penn State Hershey Anesthesiology & Perioperative Medicine, Hershey, USA (GRID:grid.29857.31) (ISNI:0000 0001 2097 4281) 
20  University of Genoa, Department of Surgical Sciences and Integrated Diagnostics, Genoa, Italy (GRID:grid.5606.5) (ISNI:0000 0001 2151 3065); IRCCS San Martino Policlinico Hospital, Genoa, Italy (GRID:grid.410345.7) (ISNI:0000 0004 1756 7871) 
21  University Hospital Aachen, Department of Anaesthesiology, Aachen, Germany (GRID:grid.412301.5) (ISNI:0000 0000 8653 1507) 
22  University of Amsterdam, Department of Intensive Care & Laboratory of Experimental Intensive Care and Anesthesiology (L·E·I·C·A), Academic Medical Center, Amsterdam, The Netherlands (GRID:grid.7177.6) (ISNI:0000000084992262); Mahidol University, Mahidol-Oxford Tropical Medicine Research Unit (MORU), Bangkok, Thailand (GRID:grid.10223.32) (ISNI:0000 0004 1937 0490) 
23  Hospital Israelita Albert Einstein, Department of Critical Care, São Paulo, Brazil (GRID:grid.413562.7) (ISNI:0000 0001 0385 1941) 
24  Università degli Studi dell’Insubria, Dipartimento di Biotecnologie e Scienze della Vita, Varese, Italy (GRID:grid.18147.3b) (ISNI:0000000121724807) 
25  Department of Anesthesiology, Centre Hospitalier Universitaire de Charleroi, Charleroi, Belgium (GRID:grid.413871.8) (ISNI:0000 0001 0124 3248) 
26  University of Debrecen, Department of Anesthesiology and Intensive Care, Debrecen, Hungary (GRID:grid.7122.6) (ISNI:0000 0001 1088 8582); Outcomes Research Consortium, Cleveland, USA (GRID:grid.7122.6) 
27  “Sotiria” Chest Diseases Hospital, Department of Anaesthesia, Postoperative ICU, Pain Relief & Palliative Care Clinic, Athens, Greece (GRID:grid.416145.3); University of Patras, Department of Anaesthesiology and Critical Care Medicine, Patra, Greece (GRID:grid.11047.33) (ISNI:0000 0004 0576 5395) 
28  Fudan University Shanghai Cancer Center, Department of Anesthesiology, Shanghai, China (GRID:grid.452404.3) (ISNI:0000 0004 1808 0942); Fudan University, Department of Oncology, Shanghai Medical College, Shanghai, China (GRID:grid.8547.e) (ISNI:0000 0001 0125 2443) 
29  University Hospital Carl Gustav Carus, Technische Universität Dresden, Department of Anesthesiology and Intensive Care Medicine, Pulmonary Engineering Group, Dresden, Germany (GRID:grid.8547.e) 
30  Istanbul University, Istanbul Medical Faculty, Department of Anaesthesiology and Intensive Care, Istanbul, Turkey (GRID:grid.9601.e) (ISNI:0000 0001 2166 6619) 
Pages
213
Publication year
2019
Publication date
Dec 2019
Publisher
BioMed Central
e-ISSN
17456215
Source type
Scholarly Journal
Language of publication
English
ProQuest document ID
2795382618
Copyright
© The Author(s). 2019. corrected publication 2019. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.