Rationale and Study Design for an Individualized Perioperative Open Lung Ventilatory Strategy in Patients on One-Lung Ventilation (iPROVE-OLV)
Por:
Carraminana, A, Ferrando, C, Unzueta, MC, Navarro, R, Suarez-Sipmann, F, Tusman, G, Garutti, I, Soro, M, Pozo, N, Librero, J, Gallego, L, Ramasco, F, Rabanal, JM, Rodriguez, A, Sastre, J, Martinez, J, Coves, S, Garcia, P, Aguirre-Puig, P, Yepes, J, Lluch, A, Lopez-Herrera, D, Leal, S, Vives, M, Bellas, S, Socorro, T, Trespalacios, R, Salazar, CJ, Mugarra, A, Cinnella, G, Spadaro, S, Futier, E, Ferrer, L, Cabrera, M, Ribeiro, H, Celestino, C, Kucur, E, Cervantes, O, Morocho, D, Delphy, D, Ramos, C, Villar, J, Belda, J, Monedero, P, Martinez, S, Comino, O, Coy, A, Armengol, L, Pineiro, P, Cruz, P, Duque, P, de la Gala, FA, Sanchez, G, Olmedilla, L, de la Fuente, E, Erquicia, I, Reyes, A, Lopez, E, Palencia, M, Bunger, B, Ramos, R, Terradillos, E, Almaraz, C, Lujan, LM, Lopez, A, Femenia, F, Botella, S, Cimadevilla, B, Pascual, R, Pardo, S, Gonzalez, M, Lopez, C, Trabanco, S, Zaldibar, E, Barolome, MJ, Pereira, D, Otero, T, Blanco, L, Reparaz, JR, Ceresuela, R, Castellano, P, Martinez, P, Martinez, O, Franco, J, Hernandez, J, Pastor, O, Solera, J, Guerra, E, Dib, ZH, Farina, R, Cabrera, S, Arribas, MP, Sastre, JA, de Celis, I, Pascual, MJ, Garcia-Barberena, B, Arango, E, Amaya, O, Madrid, G, Triana, C, Pabon, S, Diaz, DP, Ortells, F, Perez, B, Aracil, R, Sanchez, R, Acosta, J, de la Matta, M, Gonzalez, D, Mirabella, L, Rauseo, M, Lamanna, A, Volta, CA, Ragazzi, R, Cachapuz, M, Correia, I, Parera, A, Argilaga, M, Azparren, G, Bausili, M, Almajano, R, Aragon, C, Colas, A, Cotera, I, Embun, R, Forcada, P, Garces, C, Gil, F, Gracia, A, Herrero, M, Izquierdo, B, Molinos, I, Munoz, N, Puertolas, M, Quesada, N, Recuero, JL, Royo, I, Romero, B, Rubio, B, Sandin, F, Sanjuan-Villarreal, TA, Visiedo, S, Cordoba, J, Pintor, J, Planas, A, Nieves, JM, Garcia, E, Vallejo, C, Santidrian, S, Rofso, P, Arocas, B, Gutierrez, A, Charco, P, Parra, MJ, Carbonell, JA, Jurado, A, Serralta, F, Sancho, L, Barcena, E, Lascorz, L, Belmonte, L, Cuervo, J, Florea, R, Martinez, S, Monleon, B, Perez, S, Garcia, L, Hurtado, L, Pardo, P, Segura, N, Utrera, E, Martin, B, Mellado, P, Arcas, JJ, Martinez, N, Maric, M, Munoz, LE, Gonzalez, RC, Busquets, J, Homs, M, Jimenez, A, Pintanel, T, Martinez, E, Moret, E, Sercakacilar, G, Diaz, M, Souteiro, JT, Benito, A, Cebrian, A, Mestres, G, Mohamed, MI, Yousef, SA, Osman, YM, Moreno, A, Tutillo, A, Pilco, H, Pena, A, Llano, M, Carrillo, E, Salazar, C, Dominguez, D, Espinosa, E
Publicada:
1 sep 2019
Resumen:
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. (C) 2019 Published by Elsevier Inc.
Filiaciones:
Carraminana, A:
Hosp Clin Barcelona, Dept Anesthesia & Crit Care, Villarroel 170, Barcelona 08036, Spain
Ferrando, C:
Hosp Clin Barcelona, Dept Anesthesia & Crit Care, Villarroel 170, Barcelona 08036, Spain
Inst Salud Carlos III, CIBER Enfermedades Resp, Madrid, Spain
Unzueta, MC:
Hosp Santa Creu & Sant Pau, Dept Anesthesia & Crit Care, Barcelona, Spain
Navarro, R:
Hosp Clin Barcelona, Dept Anesthesia & Crit Care, Villarroel 170, Barcelona 08036, Spain
Suarez-Sipmann, F:
Inst Salud Carlos III, CIBER Enfermedades Resp, Madrid, Spain
Hosp La Princesa, Intens Care Unit, Madrid, Spain
Uppsala Univ Hosp, Dept Surg Sci, Hedenstierna Lab, Uppsala, Sweden
Tusman, G:
Hosp Privado Mar De Plata, Dept Anesthesia, Mar De Plata, Argentina
Garutti, I:
Hosp Univ Gregorio Maranon, Dept Anesthesia & Crit Care, Madrid, Spain
Soro, M:
Hosp Clin Valencia, Dept Anesthesia & Crit Care, Valencia, Spain
Pozo, N:
Hosp Clin Univ Valencia, Inst INCLIVA, Valencia, Spain
Librero, J:
Red Invest Serv Salud Enfermedades Cron REDISSEC, Navarrabiomed Fdn Miguel Servet, Pamplona, Spain
Gallego, L:
Hosp Miguel Servet, Dept Anesthesia & Crit Care, Zaragoza, Spain
Ramasco, F:
Hosp La Princesa, Dept Anesthesia & Crit Care, Madrid, Spain
Rabanal, JM:
Hosp Marques Valdecilla, Dept Anesthesia & Crit Care, Santander, Spain
Rodriguez, A:
Hosp Univ Dr Negrin, Dept Anesthesia, Las Palmas Gran Canaria, Spain
Sastre, J:
Hosp Salamanca, Dept Anesthesia & Crit Care T, Salamanca, Spain
Martinez, J:
Hosp Univ Mutua Terrassa, Dept Anesthesia & Crit Care, Terrassa, Spain
Coves, S:
Hosp Univ Vinalopo, Dept Anesthesia & Crit Care, Elche, Spain
Garcia, P:
Hosp 12 Octubre, Dept Anesthesia & Crit Care, Madrid, Spain
Aguirre-Puig, P:
Hosp Alvaro Cunqueiro, Dept Anesthesia & Crit Care, Vigo, Spain
Yepes, J:
Clin Univ Pamplona, Dept Anesthesia & Crit Care, Pamplona, Spain
Lluch, A:
Hosp Univ La Fe, Dept Anesthesia & Crit Care, Valencia, Spain
Lopez-Herrera, D:
Hosp Viigen Rocio, Dept Anesthesia & Crit Care, Seville, Spain
Leal, S:
Hosp Povisa, Dept Anesthesia & Crit Care, Vigo, Spain
Vives, M:
Hosp Dr Josep Trueta, Dept Anesthesia & Crit Care, Girona, Spain
Bellas, S:
Fdn Jimenez Diaz, Dept Anesthesia & Crit Care, Madrid, Spain
Socorro, T:
Complejo Univ MaternoInsular, Dept Anesthesia, Las Palmas Gran Canaria, Spain
Trespalacios, R:
Hosp Univ Cent Asturias, Dept Anesthesia & Crit Care, Oviedo, Spain
Salazar, CJ:
Hosp Univ Canarias, Dept Anesthesia & Crit Care, Tenerife, Spain
Mugarra, A:
Hosp Clin Valencia, Dept Anesthesia & Crit Care, Valencia, Spain
Cinnella, G:
Univ Foggia, Dept Anesthesia & Crit Care, Foggia, Italy
Spadaro, S:
Univ Ferrara, Dept Anesthesia & Crit Care, Ferrara, Italy
Futier, E:
CHU Clermont Ferrand, Anesthesia & Crit Care, Clermont Ferrand, France
Ferrer, L:
Univ El Basque, Dept Anesthesia, Bogota, Colombia
Cabrera, M:
Hosp Clin Fuerza Aerea Chile, Dept Anesthesia, Los Condes, Chile
Ribeiro, H:
Ctr Hosp Sao Joao, Dept Anesthesia & Crit Care, Porto, Portugal
Celestino, C:
Ctr Hosp Vila Nova Gaia Espinho, Dept Anesthesia & Crit Care, Vila Nova De Gaia, Portugal
Kucur, E:
Med Pk Bahcelievler Hosp, Anesthesia & Crit Care, Istanbul, Turkey
Cervantes, O:
Hosp Badalona Germans Trias & Pujol, Dept Anesthesia & Crit Care, Badalona, Spain
Morocho, D:
Hosp Especialidades Eugenio Espejo, Crit Care Dept, Quito, Ecuador
Delphy, D:
Alexandria Univ Hosp, Dept Anesthesia, Alexandria, Egypt
Kafrelsheikh Univ Hosp, Alexandria, Egypt
Ramos, C:
Hosp Univ Ntra Sra Candelaria, Dept Anesthesia & Crit Care, Santa Cruz De Tenerife, Spain
Villar, J:
Inst Salud Carlos III, CIBER Enfermedades Resp, Madrid, Spain
Hosp Univ Dr Negrin, Res Unit, Las Palmas Gran Canaria, Spain
Belda, J:
Hosp Clin Valencia, Dept Anesthesia & Crit Care, Valencia, Spain
Salazar, C:
Hosp Univ Canarias, Dept Anesthesia & Crit Care, Tenerife, Spain
Green Published, Green Submitted
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