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
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...
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| Language: | English |
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BMC
2019-04-01
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| Series: | Trials |
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| Online Access: | http://link.springer.com/article/10.1186/s13063-019-3208-8 |
| _version_ | 1828768903376928768 |
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| author | 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) |
| author_facet | 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) |
| author_sort | T. Kiss |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-12-11T13:38:07Z |
| format | Article |
| id | doaj.art-a028ba9822c84d12b4da9fbde717172a |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-11T13:38:07Z |
| publishDate | 2019-04-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-a028ba9822c84d12b4da9fbde717172a2022-12-22T01:04:55ZengBMCTrials1745-62152019-04-0120112010.1186/s13063-019-3208-8Protective ventilation with high versus low positive end-expiratory pressure during one-lung ventilation for thoracic surgery (PROTHOR): study protocol for a randomized controlled trialT. Kiss0J. Wittenstein1C. Becker2K. Birr3G. Cinnella4E. Cohen5M. R. El Tahan6L. F. Falcão7C. Gregoretti8M. Granell9T. Hachenberg10M. W. Hollmann11R. Jankovic12W. Karzai13J. Krassler14T. Loop15M. J. Licker16N. Marczin17G. H. Mills18M. T. Murrell19V. Neskovic20Z. Nisnevitch-Savarese21P. Pelosi22R. Rossaint23M. J. Schultz24A. Serpa Neto25P. Severgnini26L. Szegedi27T. Vegh28G. Voyagis29J. Zhong30M. Gama de Abreu31M. Senturk32for the PROTHOR investigatorsthe Research Workgroup PROtective VEntilation Network (PROVEnet) of the European Society of Anaesthesiology (ESA)Department of Anesthesiology and Intensive Care Medicine, Pulmonary Engineering Group, University Hospital Carl Gustav Carus, Technische Universität DresdenDepartment of Anesthesiology and Intensive Care Medicine, Pulmonary Engineering Group, University Hospital Carl Gustav Carus, Technische Universität DresdenDepartment of Anesthesiology and Intensive Care Medicine, Pulmonary Engineering Group, University Hospital Carl Gustav Carus, Technische Universität DresdenDepartment of Anesthesiology and Intensive Care Medicine, Pulmonary Engineering Group, University Hospital Carl Gustav Carus, Technische Universität DresdenDepartment of Anesthesia and Intensive Care, OO Riuniti Hospital, University of FoggiaDepartment of Anesthesiology, The Mount Sinai HospitalImam Abdulrahman Bin Faisal UniversityFederal University of São PauloUOC Anestesia e Rianimazione A.O.Universitaria “P. Giaccone”, Dipartimento Di.Chir.On.S., Università degli Studi di PalermoHospital General Universitario de ValenciaUniversity Hospital MagdeburgDepartment of Anesthesiology, Amsterdam UMC, location AMCClinic for Anesthesia and Intensive Therapy, Clinical Center Nis, School of Medicine, University of NisZentralklinik Bad BerkaThoracic Center CoswigDepartment of Anesthesiology and Intensive Care Medicine Clinic, Medical Center, University of Freiburg, Faculty of Medicine, University of FreiburgUniversity Hospital GenevaSection of Anaesthetics, Pain Medicine and Intensive Care, Department of Surgery and Cancer, Faculty of Medicine, Imperial College LondonDepartment of Anaesthesia and Intensive Care Medicine, Sheffield Teaching Hospitals, Sheffield UniversityDepartment of Anesthesiology, Weill Cornell MedicineMilitary Medical AcademyPenn State Hershey Anesthesiology & Perioperative MedicineDepartment of Surgical Sciences and Integrated Diagnostics, University of GenoaDepartment of Anaesthesiology, University Hospital AachenDepartment of Intensive Care & Laboratory of Experimental Intensive Care and Anesthesiology (L·E·I·C·A), Academic Medical Center, University of AmsterdamDepartment of Critical Care, Hospital Israelita Albert EinsteinDipartimento di Biotecnologie e Scienze della Vita, Università degli Studi dell’InsubriaDepartment of Anesthesiology, Centre Hospitalier Universitaire de CharleroiDepartment of Anesthesiology and Intensive Care, University of DebrecenDepartment of Anaesthesia, Postoperative ICU, Pain Relief & Palliative Care Clinic, “Sotiria” Chest Diseases HospitalDepartment of Anesthesiology, Fudan University Shanghai Cancer CenterDepartment of Anesthesiology and Intensive Care Medicine, Pulmonary Engineering Group, University Hospital Carl Gustav Carus, Technische Universität DresdenDepartment of Anaesthesiology and Intensive Care, Istanbul University, Istanbul Medical FacultyAbstract 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.http://link.springer.com/article/10.1186/s13063-019-3208-8Mechanical ventilationpositive end-expiratory pressurerecruitment maneuverone-lung ventilationthoracic surgerypostoperative pulmonary complication |
| spellingShingle | 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) 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 Mechanical ventilation positive end-expiratory pressure recruitment maneuver one-lung ventilation thoracic surgery postoperative pulmonary complication |
| 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Mechanical ventilation positive end-expiratory pressure recruitment maneuver one-lung ventilation thoracic surgery postoperative pulmonary complication |
| url | http://link.springer.com/article/10.1186/s13063-019-3208-8 |
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