Scientific publications
Rationale and Study Design for an Individualized Perioperative Open Lung Ventilatory Strategy in Patients on One-Lung Ventilation (iPROVE-OLV). Scientific Publication
Albert Carramiñana 1 , Carlos Ferrando 2 , M Carmen Unzueta 3 , Ricard Navarro 1 , Fernando Suárez-Sipmann 4 , Gerardo Tusman 5 , Ignacio Garutti 6 , Marina Soro 7 , Natividad Pozo 8 , Julián Librero 9 , Lucía Gallego 10 , Fernando Ramasco 11 , José M Rabanal 12 , Aurelio Rodriguez 13 , José Sastre 14 , Jesús Martinez 15 , Silvia Coves 16 , Pablo García 17 , Pilar Aguirre-Puig 18 , José Yepes 19 , Aitana Lluch 20 , Daniel López-Herrera 21 , Sonsoles Leal 22 , Marc Vives 23 , Soledad Bellas 24 , Tania Socorro 25 , Ramón Trespalacios 26 , Claudia J Salazar 27 , Ana Mugarra 7 , Gilda Cinnella 28 , Savino Spadaro 29 , Emmanuel Futier 30 , Leopoldo Ferrer 31 , María Cabrera 32 , Helder Ribeiro 33 , Catarina Celestino 34 , Evrim Kucur 35 , Oriol Cervantes 36 , Diego Morocho 37 , Dalia Delphy 38 , Carolina Ramos 39 , Jesús Villar 40 , Javier Belda 7 ; iPROVE-OLV Network
Objective: The aim of this clinical trial is to examine whether it is possible to reduce postoperative complications using an individualized perioperative ventilatory strategy versus using a standard lung-protective ventilation strategy in patients scheduled for thoracic surgery requiring one-lung ventilation.
Design: International, multicenter, prospective, randomized controlled clinical trial.
Setting: A network of university hospitals.
Participants: The study comprises 1,380 patients scheduled for thoracic surgery.
Interventions: The individualized group will receive intraoperative recruitment maneuvers followed by individualized positive end-expiratory pressure (open lung approach) during the intraoperative period plus postoperative ventilatory support with high-flow nasal cannula, whereas the control group will be managed with conventional lung-protective ventilation.
Measurements and main results: Individual and total number of postoperative complications, including atelectasis, pneumothorax, pleural effusion, pneumonia, acute lung injury; unplanned readmission and reintubation; length of stay and death in the critical care unit and in the hospital will be analyzed for both groups. The authors hypothesize that the intraoperative application of an open lung approach followed by an individual indication of high-flow nasal cannula in the postoperative period will reduce pulmonary complications and length of hospital stay in high-risk surgical patients.
CITATION J Cardiothorac Vasc Anesth. 2019 Sep;33(9):2492-2502. doi: 10.1053/j.jvca.2019.01.056. Epub 2019 Feb 8.
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