Abstract
BackgroundPostoperative 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.MethodsPROTHOR 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.DiscussionPROTHOR 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 registrationThe trial was registered in clinicaltrials.gov (NCT02963025) on 15 November 2016.
Highlights
Postoperative pulmonary complications (PPC) may result in longer duration of in-hospital stay and even mortality
The potential of high positive end-expiratory pressure (PEEP) and recruitment maneuvers (RM) during one-lung ventilation (OLV) for thoracic surgery to reduce PPC has not been investigated in adequately powered trials [19, 20]
The PEEP during OLV for THORacic surgery (PROTHOR) trial was designed to determine whether a high level of PEEP with RM, as compared to low PEEP without RM, during OLV for thoracic surgery, prevents PPC
Summary
Objectives and design PROTHOR is an international, multicenter, randomized, controlled, assessor-blinded, two-arm trial initiated by investigators of the PROtective VEntilation NETwork (http://provenet.eu). Secondary clinical endpoints include: extended PPC, including bronchospasm (defined as newly detected expiratory wheezing treated with bronchodilators) or mild respiratory failure (SpO2 < 90% or PaO2 < 60 mmHg for 10 min in room air, responding to oxygen ≤ 2 L/min) intraoperative complications (use of continuous positive airway pressure for the non-ventilated lung, use of inhaled nitric oxide/prostacycline, use of selective fiberoscope insufflation, hypotension unresponsive to fluids and/or vasoactive drugs, new arrhythmias unresponsive to intervention, need for high dosage of vasoactive drugs (a dosage at the tolerance limit of the treating physician), need for massive transfusion, life-threatening surgical complication including major bleeding, tension pneumothorax, intracranial injury, hypoxemia and hypercapnia rescue maneuvers, deviation from prescribed PEEP or VT) postoperative extrapulmonary complications need for unexpected intensive care unit admission or readmission number of hospital-free days at day 28 90-day survival in-hospital survival arterial blood gas analysis during surgery (PaO2, PaCO2, pHa) any postoperative respiratory intervention (new requirement of non-invasive ventilation or mechanical ventilation). When submitting the report on the results of the trial for possible publication, sites will be eligible to one collaborative co-authorship plus a further co-authorship for every 20 treated patients with complete datasets
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