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

被引:16
作者
Carraminana, Albert [1 ]
Ferrando, Carlos [1 ,2 ]
Unzueta, M. Carmen [3 ]
Navarro, Ricard [1 ]
Suarez-Sipmann, Fernando [2 ,4 ,5 ]
Tusman, Gerardo [6 ]
Garutti, Ignacio [7 ]
Soro, Marina [8 ]
Pozo, Natividad [9 ]
Librero, Julian [10 ]
Gallego, Lucia [11 ]
Ramasco, Fernando [12 ]
Rabanal, Jose M. [13 ]
Rodriguez, Aurelio [14 ]
Sastre, Jose [15 ]
Martinez, Jesus [16 ]
Coves, Silvia [17 ]
Garcia, Pablo [18 ]
Aguirre-Puig, Pilar [19 ]
Yepes, Jose [20 ]
Lluch, Aitana [21 ]
Lopez-Herrera, Daniel [22 ]
Leal, Sonsoles [23 ]
Vives, Marc [24 ]
Bellas, Soledad [25 ]
Socorro, Tania [26 ]
Trespalacios, Ramon [27 ]
Salazar, Claudia J. [28 ]
Mugarra, Ana [8 ]
Cinnella, Gilda [29 ]
Spadaro, Savino [30 ]
Futier, Emmanuel [31 ]
Ferrer, Leopoldo [32 ]
Cabrera, Maria [33 ]
Ribeiro, Helder [34 ]
Celestino, Catarina [35 ]
Kucur, Evrim [36 ]
Cervantes, Oriol [37 ]
Morocho, Diego [38 ]
Delphy, Dalia [39 ,40 ]
Ramos, Carolina [41 ]
Villar, Jesus [2 ,42 ]
Belda, Javier [8 ]
Monedero, Pablo
Martinez, Samira
Comino, Oscar
Coy, Alberto
Armengol, Laura
Pineiro, Patricia
Cruz, Patricia
机构
[1] Hosp Clin Barcelona, Dept Anesthesia & Crit Care, Villarroel 170, Barcelona 08036, Spain
[2] Inst Salud Carlos III, CIBER Enfermedades Resp, Madrid, Spain
[3] Hosp Santa Creu & Sant Pau, Dept Anesthesia & Crit Care, Barcelona, Spain
[4] Hosp La Princesa, Intens Care Unit, Madrid, Spain
[5] Uppsala Univ Hosp, Dept Surg Sci, Hedenstierna Lab, Uppsala, Sweden
[6] Hosp Privado Mar De Plata, Dept Anesthesia, Mar De Plata, Argentina
[7] Hosp Univ Gregorio Maranon, Dept Anesthesia & Crit Care, Madrid, Spain
[8] Hosp Clin Valencia, Dept Anesthesia & Crit Care, Valencia, Spain
[9] Hosp Clin Univ Valencia, Inst INCLIVA, Valencia, Spain
[10] Red Invest Serv Salud Enfermedades Cron REDISSEC, Navarrabiomed Fdn Miguel Servet, Pamplona, Spain
[11] Hosp Miguel Servet, Dept Anesthesia & Crit Care, Zaragoza, Spain
[12] Hosp La Princesa, Dept Anesthesia & Crit Care, Madrid, Spain
[13] Hosp Marques Valdecilla, Dept Anesthesia & Crit Care, Santander, Spain
[14] Hosp Univ Dr Negrin, Dept Anesthesia, Las Palmas Gran Canaria, Spain
[15] Hosp Salamanca, Dept Anesthesia & Crit Care T, Salamanca, Spain
[16] Hosp Univ Mutua Terrassa, Dept Anesthesia & Crit Care, Terrassa, Spain
[17] Hosp Univ Vinalopo, Dept Anesthesia & Crit Care, Elche, Spain
[18] Hosp 12 Octubre, Dept Anesthesia & Crit Care, Madrid, Spain
[19] Hosp Alvaro Cunqueiro, Dept Anesthesia & Crit Care, Vigo, Spain
[20] Clin Univ Pamplona, Dept Anesthesia & Crit Care, Pamplona, Spain
[21] Hosp Univ La Fe, Dept Anesthesia & Crit Care, Valencia, Spain
[22] Hosp Viigen Rocio, Dept Anesthesia & Crit Care, Seville, Spain
[23] Hosp Povisa, Dept Anesthesia & Crit Care, Vigo, Spain
[24] Hosp Dr Josep Trueta, Dept Anesthesia & Crit Care, Girona, Spain
[25] Fdn Jimenez Diaz, Dept Anesthesia & Crit Care, Madrid, Spain
[26] Complejo Univ MaternoInsular, Dept Anesthesia, Las Palmas Gran Canaria, Spain
[27] Hosp Univ Cent Asturias, Dept Anesthesia & Crit Care, Oviedo, Spain
[28] Hosp Univ Canarias, Dept Anesthesia & Crit Care, Tenerife, Spain
[29] Univ Foggia, Dept Anesthesia & Crit Care, Foggia, Italy
[30] Univ Ferrara, Dept Anesthesia & Crit Care, Ferrara, Italy
[31] CHU Clermont Ferrand, Anesthesia & Crit Care, Clermont Ferrand, France
[32] Univ El Basque, Dept Anesthesia, Bogota, Colombia
[33] Hosp Clin Fuerza Aerea Chile, Dept Anesthesia, Los Condes, Chile
[34] Ctr Hosp Sao Joao, Dept Anesthesia & Crit Care, Porto, Portugal
[35] Ctr Hosp Vila Nova Gaia Espinho, Dept Anesthesia & Crit Care, Vila Nova De Gaia, Portugal
[36] Med Pk Bahcelievler Hosp, Anesthesia & Crit Care, Istanbul, Turkey
[37] Hosp Badalona Germans Trias & Pujol, Dept Anesthesia & Crit Care, Badalona, Spain
[38] Hosp Especialidades Eugenio Espejo, Crit Care Dept, Quito, Ecuador
[39] Alexandria Univ Hosp, Dept Anesthesia, Alexandria, Egypt
[40] Kafrelsheikh Univ Hosp, Alexandria, Egypt
[41] Hosp Univ Ntra Sra Candelaria, Dept Anesthesia & Crit Care, Santa Cruz De Tenerife, Spain
[42] Hosp Univ Dr Negrin, Res Unit, Las Palmas Gran Canaria, Spain
关键词
mechanical ventilation; postoperative pulmonary complications; one-lung ventilation; positive end-expiratory pressure; recruitment maneuvers; POSTOPERATIVE PULMONARY COMPLICATIONS; ALVEOLAR RECRUITMENT STRATEGY; RESPIRATORY-DISTRESS-SYNDROME; PROTECTIVE VENTILATION; NONINVASIVE VENTILATION; ARTERIAL OXYGENATION; THORACIC-SURGERY; TIDAL VOLUMES; IMPROVES; ATELECTASIS;
D O I
10.1053/j.jvca.2019.01.056
中图分类号
R614 [麻醉学];
学科分类号
100217 ;
摘要
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.
引用
收藏
页码:2492 / 2502
页数:11
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