6533b874fe1ef96bd12d6811
RESEARCH PRODUCT
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. KissJ. WittensteinC. BeckerK. BirrG. CinnellaE. CohenM. R. El TahanL. F. FalcaoC. GregorettiM. GranellT. HachenbergM. W. HollmannR. JankovicW. KarzaiJ. KrasslerT. LoopM. J. LickerN. MarczinG. H. MillsM. T. MurrellV. NeskovicZ. Nisnevitch-savareseP. PelosiR. RossaintM. J. SchultzA. Serpa NetoP. SevergniniL. SzegediT. VeghG. VoyagisJ. ZhongM. Gama De AbreuM. SenturkAlberto Notosubject
Positive-Pressure RespirationMechanical ventilation; one-lung ventilation; positive end-expiratory pressure; postoperative pulmonary complication; recruitment maneuver; thoracic surgery; Humans; Intraoperative Complications; One-Lung Ventilation; Positive-Pressure Respiration; Research Design; Sample Size; Thoracic Surgical Procedures; Randomized Controlled Trials as TopicResearch DesignSample SizeHumansCorrectionThoracic Surgical ProceduresIntraoperative ComplicationsOne-Lung VentilationRandomized Controlled Trials as Topicdescription
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.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/mPROTHOR 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.The trial was registered in clinicaltrials.gov ( NCT02963025 ) on 15 November 2016.
| year | journal | country | edition | language |
|---|---|---|---|---|
| 2018-10-21 | Trials |