Publication:
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

Issued Date

2019-04-11

Resource Type

Article

ISSN

17456215

DOI

10.1186/s13063-019-3208-8

Other identifier(s)

2-s2.0-85064218287

Rights

Mahidol University

Rights Holder(s)

SCOPUS

Bibliographic Citation

Trials. Vol.20, No.1 (2019)

Suggested Citation

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 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. Trials. Vol.20, No.1 (2019). doi:10.1186/s13063-019-3208-8 Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/51724

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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

Author(s)

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

Other Contributor(s)

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

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 clinicaltrials.gov (NCT02963025) on 15 November 2016.

Keyword(s)

Medicine

Availability

URI

https://repository.li.mahidol.ac.th/handle/20.500.14594/51724

Collections

Scopus 2019