RESUMEN
After publication of the original article [1], the authors have notified us that two of the collaborator first and last names have been inverted in the "PROTHOR Investigators" table.
RESUMEN
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.
Asunto(s)
Ventilación Unipulmonar/métodos , Respiración con Presión Positiva/métodos , Ensayos Clínicos Controlados Aleatorios como Asunto , Procedimientos Quirúrgicos Torácicos/métodos , Humanos , Complicaciones Intraoperatorias/terapia , Proyectos de Investigación , Tamaño de la MuestraRESUMEN
BACKGROUND: The use of ultrasound (US) in regional anaesthesia enables a reduction in the local anaesthetic volume. The present study aimed to determine the minimum effective volume (MEV(90)) of 0.5% bupivacaine with epinephrine for interscalene brachial plexus block (ISBPB). METHODS: The volume of the anaesthetic was determined using a step-up/step-down method and was based on the outcome of the preceding block. A positive or negative block resulted in a 1 ml reduction or increase in volume, respectively. The success of the block was defined as the presence of motor block in three muscle groups and the absence of thermal and pain sensations in three dermatomes within 30 min of the injection. Diaphragmatic paralysis and analgesia were assessed at 30 min, 4, and 6 h. RESULTS: The MEV(90) for US-guided brachial plexus block under the conditions of the present study was 0.95 ml [R(2): 0.97, 95% confidence interval (CI): 0.6-1.22 ml]. The estimated maximum volume that did not cause diaphragmatic block was 4.29 ml (R(2): 0.84, 95% CI: 3.56-4.98 ml). Effective postoperative analgesia was achieved with 2.34 ml (R(2): 0.87, 95% CI: 0.48-11.47 ml). CONCLUSIONS: The MEV(90) of 0.5% bupivacaine with epinephrine (1:200 000) for US-guided ISBPB was 0.95 ml. Adequate postoperative analgesia and a reduced incidence of diaphragmatic block can be obtained using from 2.34 to 4.29 ml. ClinicalTrials.gov. Registry NCT01244932.
