Rationale and Study Design for an Individualized Perioperative Open Lung Ventilatory Strategy in Patients on One-Lung Ventilation (iPROVE-OLV)

• Published in: Journal of cardiothoracic and vascular anesthesia Vol. 33; no. 9; pp. 2492 - 2502
• Main Authors: Carramiñana, Albert, Ferrando, Carlos, Unzueta, M. Carmen, Navarro, Ricard, Suárez-Sipmann, Fernando, Tusman, Gerardo, Garutti, Ignacio, Soro, Marina, Pozo, Natividad, Librero, Julián, Gallego, Lucía, Ramasco, Fernando, Rabanal, José M., Rodriguez, Aurelio, Sastre, José, Martinez, Jesús, Coves, Silvia, García, Pablo, Aguirre-Puig, Pilar, Yepes, José, Lluch, Aitana, López-Herrera, Daniel, Leal, Sonsoles, Vives, Marc, Bellas, Soledad, Socorro, Tania, Trespalacios, Ramón, Salazar, Claudia J., Mugarra, Ana, Cinnella, Gilda, Spadaro, Savino, Futier, Emmanuel, Ferrer, Leopoldo, Cabrera, María, Ribeiro, Helder, Celestino, Catarina, Kucur, Evrim, Cervantes, Oriol, Morocho, Diego, Delphy, Dalia, Ramos, Carolina, Villar, Jesús, Belda, Javier
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.09.2019
• Subjects: mechanical ventilation; one-lung ventilation; positive end-expiratory pressure; postoperative pulmonary complications; recruitment maneuvers; postoperative pulmonary complications; recruitment maneuvers; positive end-expiratory pressure; mechanical ventilation; one-lung ventilation
• ISSN: 1053-0770; 1532-8422; 1532-8422
• DOI: 10.1053/j.jvca.2019.01.056

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. International, multicenter, prospective, randomized controlled clinical trial. A network of university hospitals. The study comprises 1,380 patients scheduled for thoracic surgery. 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. 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.