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

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. Ausführliche Beschreibung

Gespeichert in:

Autor*in:	Kiss, T. [verfasserIn] Wittenstein, J. Becker, C. Birr, K. Cinnella, G. Cohen, E. El Tahan, M. R. Falcão, L. F. Gregoretti, C. Granell, M. Hachenberg, T. Hollmann, M. W. Jankovic, R. Karzai, W. Krassler, J. Loop, T. Licker, M. J. Marczin, N. Mills, G. H. Murrell, M. T. Neskovic, V. Nisnevitch-Savarese, Z. Pelosi, P. Rossaint, R. Schultz, M. J. Serpa Neto, A. Severgnini, P. Szegedi, L. Vegh, T. Voyagis, G. Zhong, J. Gama de Abreu, M. Senturk, M.

Format:	E-Artikel
Sprache:	Englisch

Erschienen:	2019

Schlagwörter:	Mechanical ventilation positive end-expiratory pressure recruitment maneuver one-lung ventilation thoracic surgery postoperative pulmonary complication

Anmerkung:	© The Author(s). 2019. corrected publication 2019

Übergeordnetes Werk:	Enthalten in: Trials - London : BioMed Central, 2000, 20(2019), 1 vom: 11. Apr.
Übergeordnetes Werk:	volume:20 ; year:2019 ; number:1 ; day:11 ; month:04

Links:	Volltext

DOI / URN:	10.1186/s13063-019-3208-8

Katalog-ID:	SPR030109027

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520			\|a 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.
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700	1		\|a Hachenberg, T. \|4 aut
700	1		\|a Hollmann, M. W. \|4 aut
700	1		\|a Jankovic, R. \|4 aut
700	1		\|a Karzai, W. \|4 aut
700	1		\|a Krassler, J. \|4 aut
700	1		\|a Loop, T. \|4 aut
700	1		\|a Licker, M. J. \|4 aut
700	1		\|a Marczin, N. \|4 aut
700	1		\|a Mills, G. H. \|4 aut
700	1		\|a Murrell, M. T. \|4 aut
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700	1		\|a Nisnevitch-Savarese, Z. \|4 aut
700	1		\|a Pelosi, P. \|4 aut
700	1		\|a Rossaint, R. \|4 aut
700	1		\|a Schultz, M. J. \|4 aut
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700	1		\|a Severgnini, P. \|4 aut
700	1		\|a Szegedi, L. \|4 aut
700	1		\|a Vegh, T. \|4 aut
700	1		\|a Voyagis, G. \|4 aut
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allfields	10.1186/s13063-019-3208-8 doi (DE-627)SPR030109027 (SPR)s13063-019-3208-8-e DE-627 ger DE-627 rakwb eng Kiss, T. verfasserin (orcid)0000-0002-8276-1916 aut 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 2019 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s). 2019. corrected publication 2019 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. Mechanical ventilation (dpeaa)DE-He213 positive end-expiratory pressure (dpeaa)DE-He213 recruitment maneuver (dpeaa)DE-He213 one-lung ventilation (dpeaa)DE-He213 thoracic surgery (dpeaa)DE-He213 postoperative pulmonary complication (dpeaa)DE-He213 Wittenstein, J. aut Becker, C. aut Birr, K. aut Cinnella, G. aut Cohen, E. aut El Tahan, M. R. aut Falcão, L. F. aut Gregoretti, C. aut Granell, M. aut Hachenberg, T. aut Hollmann, M. W. aut Jankovic, R. aut Karzai, W. aut Krassler, J. aut Loop, T. aut Licker, M. J. aut Marczin, N. aut Mills, G. H. aut Murrell, M. T. aut Neskovic, V. aut Nisnevitch-Savarese, Z. aut Pelosi, P. aut Rossaint, R. aut Schultz, M. J. aut Serpa Neto, A. aut Severgnini, P. aut Szegedi, L. aut Vegh, T. aut Voyagis, G. aut Zhong, J. aut Gama de Abreu, M. aut Senturk, M. aut Enthalten in Trials London : BioMed Central, 2000 20(2019), 1 vom: 11. Apr. (DE-627)326173552 (DE-600)2040523-6 1745-6215 nnns volume:20 year:2019 number:1 day:11 month:04 https://dx.doi.org/10.1186/s13063-019-3208-8 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 20 2019 1 11 04
spelling	10.1186/s13063-019-3208-8 doi (DE-627)SPR030109027 (SPR)s13063-019-3208-8-e DE-627 ger DE-627 rakwb eng Kiss, T. verfasserin (orcid)0000-0002-8276-1916 aut 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 2019 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s). 2019. corrected publication 2019 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. Mechanical ventilation (dpeaa)DE-He213 positive end-expiratory pressure (dpeaa)DE-He213 recruitment maneuver (dpeaa)DE-He213 one-lung ventilation (dpeaa)DE-He213 thoracic surgery (dpeaa)DE-He213 postoperative pulmonary complication (dpeaa)DE-He213 Wittenstein, J. aut Becker, C. aut Birr, K. aut Cinnella, G. aut Cohen, E. aut El Tahan, M. R. aut Falcão, L. F. aut Gregoretti, C. aut Granell, M. aut Hachenberg, T. aut Hollmann, M. W. aut Jankovic, R. aut Karzai, W. aut Krassler, J. aut Loop, T. aut Licker, M. J. aut Marczin, N. aut Mills, G. H. aut Murrell, M. T. aut Neskovic, V. aut Nisnevitch-Savarese, Z. aut Pelosi, P. aut Rossaint, R. aut Schultz, M. J. aut Serpa Neto, A. aut Severgnini, P. aut Szegedi, L. aut Vegh, T. aut Voyagis, G. aut Zhong, J. aut Gama de Abreu, M. aut Senturk, M. aut Enthalten in Trials London : BioMed Central, 2000 20(2019), 1 vom: 11. Apr. (DE-627)326173552 (DE-600)2040523-6 1745-6215 nnns volume:20 year:2019 number:1 day:11 month:04 https://dx.doi.org/10.1186/s13063-019-3208-8 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 20 2019 1 11 04
allfields_unstemmed	10.1186/s13063-019-3208-8 doi (DE-627)SPR030109027 (SPR)s13063-019-3208-8-e DE-627 ger DE-627 rakwb eng Kiss, T. verfasserin (orcid)0000-0002-8276-1916 aut 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 2019 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s). 2019. corrected publication 2019 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. Mechanical ventilation (dpeaa)DE-He213 positive end-expiratory pressure (dpeaa)DE-He213 recruitment maneuver (dpeaa)DE-He213 one-lung ventilation (dpeaa)DE-He213 thoracic surgery (dpeaa)DE-He213 postoperative pulmonary complication (dpeaa)DE-He213 Wittenstein, J. aut Becker, C. aut Birr, K. aut Cinnella, G. aut Cohen, E. aut El Tahan, M. R. aut Falcão, L. F. aut Gregoretti, C. aut Granell, M. aut Hachenberg, T. aut Hollmann, M. W. aut Jankovic, R. aut Karzai, W. aut Krassler, J. aut Loop, T. aut Licker, M. J. aut Marczin, N. aut Mills, G. H. aut Murrell, M. T. aut Neskovic, V. aut Nisnevitch-Savarese, Z. aut Pelosi, P. aut Rossaint, R. aut Schultz, M. J. aut Serpa Neto, A. aut Severgnini, P. aut Szegedi, L. aut Vegh, T. aut Voyagis, G. aut Zhong, J. aut Gama de Abreu, M. aut Senturk, M. aut Enthalten in Trials London : BioMed Central, 2000 20(2019), 1 vom: 11. Apr. (DE-627)326173552 (DE-600)2040523-6 1745-6215 nnns volume:20 year:2019 number:1 day:11 month:04 https://dx.doi.org/10.1186/s13063-019-3208-8 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 20 2019 1 11 04
allfieldsGer	10.1186/s13063-019-3208-8 doi (DE-627)SPR030109027 (SPR)s13063-019-3208-8-e DE-627 ger DE-627 rakwb eng Kiss, T. verfasserin (orcid)0000-0002-8276-1916 aut 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 2019 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s). 2019. corrected publication 2019 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. Mechanical ventilation (dpeaa)DE-He213 positive end-expiratory pressure (dpeaa)DE-He213 recruitment maneuver (dpeaa)DE-He213 one-lung ventilation (dpeaa)DE-He213 thoracic surgery (dpeaa)DE-He213 postoperative pulmonary complication (dpeaa)DE-He213 Wittenstein, J. aut Becker, C. aut Birr, K. aut Cinnella, G. aut Cohen, E. aut El Tahan, M. R. aut Falcão, L. F. aut Gregoretti, C. aut Granell, M. aut Hachenberg, T. aut Hollmann, M. W. aut Jankovic, R. aut Karzai, W. aut Krassler, J. aut Loop, T. aut Licker, M. J. aut Marczin, N. aut Mills, G. H. aut Murrell, M. T. aut Neskovic, V. aut Nisnevitch-Savarese, Z. aut Pelosi, P. aut Rossaint, R. aut Schultz, M. J. aut Serpa Neto, A. aut Severgnini, P. aut Szegedi, L. aut Vegh, T. aut Voyagis, G. aut Zhong, J. aut Gama de Abreu, M. aut Senturk, M. aut Enthalten in Trials London : BioMed Central, 2000 20(2019), 1 vom: 11. Apr. (DE-627)326173552 (DE-600)2040523-6 1745-6215 nnns volume:20 year:2019 number:1 day:11 month:04 https://dx.doi.org/10.1186/s13063-019-3208-8 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 20 2019 1 11 04
allfieldsSound	10.1186/s13063-019-3208-8 doi (DE-627)SPR030109027 (SPR)s13063-019-3208-8-e DE-627 ger DE-627 rakwb eng Kiss, T. verfasserin (orcid)0000-0002-8276-1916 aut 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 2019 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s). 2019. corrected publication 2019 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. Mechanical ventilation (dpeaa)DE-He213 positive end-expiratory pressure (dpeaa)DE-He213 recruitment maneuver (dpeaa)DE-He213 one-lung ventilation (dpeaa)DE-He213 thoracic surgery (dpeaa)DE-He213 postoperative pulmonary complication (dpeaa)DE-He213 Wittenstein, J. aut Becker, C. aut Birr, K. aut Cinnella, G. aut Cohen, E. aut El Tahan, M. R. aut Falcão, L. F. aut Gregoretti, C. aut Granell, M. aut Hachenberg, T. aut Hollmann, M. W. aut Jankovic, R. aut Karzai, W. aut Krassler, J. aut Loop, T. aut Licker, M. J. aut Marczin, N. aut Mills, G. H. aut Murrell, M. T. aut Neskovic, V. aut Nisnevitch-Savarese, Z. aut Pelosi, P. aut Rossaint, R. aut Schultz, M. J. aut Serpa Neto, A. aut Severgnini, P. aut Szegedi, L. aut Vegh, T. aut Voyagis, G. aut Zhong, J. aut Gama de Abreu, M. aut Senturk, M. aut Enthalten in Trials London : BioMed Central, 2000 20(2019), 1 vom: 11. Apr. (DE-627)326173552 (DE-600)2040523-6 1745-6215 nnns volume:20 year:2019 number:1 day:11 month:04 https://dx.doi.org/10.1186/s13063-019-3208-8 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 20 2019 1 11 04
language	English
source	Enthalten in Trials 20(2019), 1 vom: 11. Apr. volume:20 year:2019 number:1 day:11 month:04
sourceStr	Enthalten in Trials 20(2019), 1 vom: 11. Apr. volume:20 year:2019 number:1 day:11 month:04
format_phy_str_mv	Article
institution	findex.gbv.de
topic_facet	Mechanical ventilation positive end-expiratory pressure recruitment maneuver one-lung ventilation thoracic surgery postoperative pulmonary complication
isfreeaccess_bool	true
container_title	Trials
authorswithroles_txt_mv	Kiss, T. @@aut@@ Wittenstein, J. @@aut@@ Becker, C. @@aut@@ Birr, K. @@aut@@ Cinnella, G. @@aut@@ Cohen, E. @@aut@@ El Tahan, M. R. @@aut@@ Falcão, L. F. @@aut@@ Gregoretti, C. @@aut@@ Granell, M. @@aut@@ Hachenberg, T. @@aut@@ Hollmann, M. W. @@aut@@ Jankovic, R. @@aut@@ Karzai, W. @@aut@@ Krassler, J. @@aut@@ Loop, T. @@aut@@ Licker, M. J. @@aut@@ Marczin, N. @@aut@@ Mills, G. H. @@aut@@ Murrell, M. T. @@aut@@ Neskovic, V. @@aut@@ Nisnevitch-Savarese, Z. @@aut@@ Pelosi, P. @@aut@@ Rossaint, R. @@aut@@ Schultz, M. J. @@aut@@ Serpa Neto, A. @@aut@@ Severgnini, P. @@aut@@ Szegedi, L. @@aut@@ Vegh, T. @@aut@@ Voyagis, G. @@aut@@ Zhong, J. @@aut@@ Gama de Abreu, M. @@aut@@ Senturk, M. @@aut@@
publishDateDaySort_date	2019-04-11T00:00:00Z
hierarchy_top_id	326173552
id	SPR030109027
language_de	englisch
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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. 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author	Kiss, T.
spellingShingle	Kiss, T. misc Mechanical ventilation misc positive end-expiratory pressure misc recruitment maneuver misc one-lung ventilation misc thoracic surgery misc postoperative pulmonary complication 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
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topic_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 Mechanical ventilation (dpeaa)DE-He213 positive end-expiratory pressure (dpeaa)DE-He213 recruitment maneuver (dpeaa)DE-He213 one-lung ventilation (dpeaa)DE-He213 thoracic surgery (dpeaa)DE-He213 postoperative pulmonary complication (dpeaa)DE-He213
topic	misc Mechanical ventilation misc positive end-expiratory pressure misc recruitment maneuver misc one-lung ventilation misc thoracic surgery misc postoperative pulmonary complication
topic_unstemmed	misc Mechanical ventilation misc positive end-expiratory pressure misc recruitment maneuver misc one-lung ventilation misc thoracic surgery misc postoperative pulmonary complication
topic_browse	misc Mechanical ventilation misc positive end-expiratory pressure misc recruitment maneuver misc one-lung ventilation misc thoracic surgery misc postoperative pulmonary complication
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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
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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
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author_browse	Kiss, T. Wittenstein, J. Becker, C. Birr, K. Cinnella, G. Cohen, E. El Tahan, M. R. Falcão, L. F. Gregoretti, C. Granell, M. Hachenberg, T. Hollmann, M. W. Jankovic, R. Karzai, W. Krassler, J. Loop, T. Licker, M. J. Marczin, N. Mills, G. H. Murrell, M. T. Neskovic, V. Nisnevitch-Savarese, Z. Pelosi, P. Rossaint, R. Schultz, M. J. Serpa Neto, A. Severgnini, P. Szegedi, L. Vegh, T. Voyagis, G. Zhong, J. Gama de Abreu, M. Senturk, M.
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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
title_auth	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 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} $O without RM. During two-lung ventilation tidal volume is set at 7 mL/kg predicted body weight and, during OLV, it will be decreased to 5 mL/kg. The occurrence of PPC will be recorded as a collapsed composite of single adverse pulmonary events and represents the primary endpoint. Discussion PROTHOR is the first randomized controlled trial in patients undergoing thoracic surgery with OLV that is adequately powered to compare the effects of intraoperative high PEEP with RM versus low PEEP without RM on PPC. The results of the PROTHOR trial will support anesthesiologists in their decision to set intraoperative PEEP during protective ventilation for OLV in thoracic surgery. Trial registration The trial was registered in clinicaltrials.gov (NCT02963025) on 15 November 2016. © The Author(s). 2019. corrected publication 2019
abstractGer	Background Postoperative pulmonary complications (PPC) may result in longer duration of in-hospital stay and even mortality. Both thoracic surgery and intraoperative mechanical ventilation settings add considerably to the risk of PPC. It is unclear if one-lung ventilation (OLV) for thoracic surgery with a strategy of intraoperative high positive end-expiratory pressure (PEEP) and recruitment maneuvers (RM) reduces PPC, compared to low PEEP without RM. Methods PROTHOR is an international, multicenter, randomized, controlled, assessor-blinded, two-arm trial initiated by investigators of the PROtective VEntilation NETwork. In total, 2378 patients will be randomly assigned to one of two different intraoperative mechanical ventilation strategies. Investigators screen patients aged 18 years or older, scheduled for open thoracic or video-assisted thoracoscopic surgery under general anesthesia requiring OLV, with a maximal body mass index of 35 kg/$ 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} $O without RM. During two-lung ventilation tidal volume is set at 7 mL/kg predicted body weight and, during OLV, it will be decreased to 5 mL/kg. The occurrence of PPC will be recorded as a collapsed composite of single adverse pulmonary events and represents the primary endpoint. Discussion PROTHOR is the first randomized controlled trial in patients undergoing thoracic surgery with OLV that is adequately powered to compare the effects of intraoperative high PEEP with RM versus low PEEP without RM on PPC. The results of the PROTHOR trial will support anesthesiologists in their decision to set intraoperative PEEP during protective ventilation for OLV in thoracic surgery. Trial registration The trial was registered in clinicaltrials.gov (NCT02963025) on 15 November 2016. © The Author(s). 2019. corrected publication 2019
abstract_unstemmed	Background Postoperative pulmonary complications (PPC) may result in longer duration of in-hospital stay and even mortality. Both thoracic surgery and intraoperative mechanical ventilation settings add considerably to the risk of PPC. It is unclear if one-lung ventilation (OLV) for thoracic surgery with a strategy of intraoperative high positive end-expiratory pressure (PEEP) and recruitment maneuvers (RM) reduces PPC, compared to low PEEP without RM. Methods PROTHOR is an international, multicenter, randomized, controlled, assessor-blinded, two-arm trial initiated by investigators of the PROtective VEntilation NETwork. In total, 2378 patients will be randomly assigned to one of two different intraoperative mechanical ventilation strategies. Investigators screen patients aged 18 years or older, scheduled for open thoracic or video-assisted thoracoscopic surgery under general anesthesia requiring OLV, with a maximal body mass index of 35 kg/$ 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. © The Author(s). 2019. corrected publication 2019
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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
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fullrecord_marcxml	<?xml version="1.0" encoding="UTF-8"?><collection xmlns="http://www.loc.gov/MARC21/slim"><record><leader>01000caa a22002652 4500</leader><controlfield tag="001">SPR030109027</controlfield><controlfield tag="003">DE-627</controlfield><controlfield tag="005">20230519161858.0</controlfield><controlfield tag="007">cr uuu---uuuuu</controlfield><controlfield tag="008">201007s2019 xx \|\|\|\|\|o 00\| \|\|eng c</controlfield><datafield tag="024" ind1="7" ind2=" "><subfield code="a">10.1186/s13063-019-3208-8</subfield><subfield code="2">doi</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(DE-627)SPR030109027</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(SPR)s13063-019-3208-8-e</subfield></datafield><datafield tag="040" ind1=" " ind2=" "><subfield code="a">DE-627</subfield><subfield code="b">ger</subfield><subfield code="c">DE-627</subfield><subfield code="e">rakwb</subfield></datafield><datafield tag="041" ind1=" " ind2=" "><subfield code="a">eng</subfield></datafield><datafield tag="100" ind1="1" ind2=" "><subfield code="a">Kiss, T.</subfield><subfield code="e">verfasserin</subfield><subfield code="0">(orcid)0000-0002-8276-1916</subfield><subfield code="4">aut</subfield></datafield><datafield tag="245" ind1="1" ind2="0"><subfield code="a">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</subfield></datafield><datafield tag="264" ind1=" " ind2="1"><subfield code="c">2019</subfield></datafield><datafield tag="336" ind1=" " ind2=" "><subfield code="a">Text</subfield><subfield code="b">txt</subfield><subfield code="2">rdacontent</subfield></datafield><datafield tag="337" ind1=" " ind2=" "><subfield code="a">Computermedien</subfield><subfield code="b">c</subfield><subfield code="2">rdamedia</subfield></datafield><datafield tag="338" ind1=" " ind2=" "><subfield code="a">Online-Ressource</subfield><subfield code="b">cr</subfield><subfield code="2">rdacarrier</subfield></datafield><datafield tag="500" ind1=" " ind2=" "><subfield code="a">© The Author(s). 2019. corrected publication 2019</subfield></datafield><datafield tag="520" ind1=" " ind2=" "><subfield code="a">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. 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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

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