1. Individualised perioperative open-lung approach versus standard protective ventilation in abdominal surgery (iPROVE): a randomised controlled trial
- Author
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Rubén Villazala, Victoria Moral, Nazario Ojeda, Andrea Gutierrez, Tania Socorro, Inmaculada India, Angels Lozano, Ana Mugarra, Natividad Pozo, Jose Ignacio García, María Dolores Alonso, Ernesto Pastor, Amanda Miñana, Ana Isabel Galve, Elena Lozano, Eduardo Llamazares, Gonzalo Azparren, Ana Parera, Lucas Rovira, Rafael González, Luis Olmedilla, José I. Navarro, Javier Contreras García, Carolina Romero, Abigail Villena, Julián Librero, David Pestaña, Mercedes García, Cristina Parrilla, Isabel Fuentes, Carmen Fernández, Pedro Charco, Lucía Gallego, Jesús Acosta, Maria Del Barrio, Cristina Garcés, Maite Ibáñez, Nuria Garcia, Salvador Peiró, Javier Ignacio Román, Elena Del Río, Sergio Sánchez, Lorena Muñoz, Amalia Alcón, Carmen Unzueta, Roger Pujol, Cesar Aldecoa, Maria Garcia, Lucía Valencia, Estefanía Chamorro, Clara Gallego, Jesús Rico-Feijoo, María Pilar Argente, Laura Soriano, Fernando Díez, Inmaculada Benítez, Andrea Brunelli, Natalia Peña, Vicente Torres, María Asunción Parra, Alicia Llombart, Samuel Hernández, Gerardo Aguilar, Patricia Piñeiro, Albert Carramiñana, Ferran Serralta, Ignacio Garutti, Jose M. Alonso, Beatriz Garrigues, Gerardo Tusman, Irene León, Marta Giné, Patricia Cruz, Antonio Katime, Ana Asensio, Esther Romero, Francisco Daviu, Susana Díaz, Jonathan Olmedo, Viviana Varón, Sara Zapatero, María José Alberola, Francisco J Redondo, Cristina Lisbona, Isabel Ruiz, Tania Moreno, Pablo Garcia, Ana Izquierdo, Jesús Villar, Alberto Gallego-Casilda, Blanca Arocas, Begoña Ayas, Jaume Puig, José A. Carbonell, Oto Padrón, Marina Soro, Ester Sánchez, Natalia Bejarano, Oscar Diaz-Cambronero, Ruben Díaz, María Vila, Ana María Pérez, Francisco Sandín, Ramiro López, Estefania Gracia, Manuel Tisner, Virginia Cegarra, María Hernández, Jaume Canet, Graciella Martínez-Pallí, José M. Marcos, Angeles de Miguel, Jaume Balust, Laura Vaquero, Sergio Cabrera, Fernando Suarez-Sipmann, Daniel López-Herrera, Juan Carrizo, Mercedes Ayuso, Nilda Martínez, Silvia Martín, Rayco Rodríguez, Rafael Anaya, Jose María Pérez, Rosa Lardies, M. Granell, Domingo González, Inmaculada Hernández, Rosa Dosdá, Carlos Ferrando, Carlos Delgado, Mario De Fez, Santiago García-del-Valle, Ana Jurado, Guido Mazzinari, Paola Valls, Marta Agilaga, Antonio Romero, Victor Balandrón, Alejandro Duca, Rocío Martínez, Francisco Barrios, Ma Justina Etulain, Tania Franco, Vicente Gilabert, Laura Piqueras, Aurelio Rodríguez, Javier Belda, Lisset Miguel, José Valdivia, Ana Colás, and Manuel de la Matta
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Male ,Pulmonary and Respiratory Medicine ,medicine.medical_treatment ,Population ,Perioperative Care ,law.invention ,Positive-Pressure Respiration ,03 medical and health sciences ,Postoperative Complications ,0302 clinical medicine ,Randomized controlled trial ,030202 anesthesiology ,law ,Oxygen therapy ,Abdomen ,medicine ,Humans ,Prospective Studies ,030212 general & internal medicine ,Continuous positive airway pressure ,education ,Lung ,Aged ,Mechanical ventilation ,education.field_of_study ,business.industry ,Perioperative ,Middle Aged ,Respiration, Artificial ,respiratory tract diseases ,Treatment Outcome ,Spain ,Anesthesia ,Breathing ,Female ,business ,Abdominal surgery - Abstract
Background The effects of individualised perioperative lung-protective ventilation (based on the open-lung approach [OLA]) on postoperative complications is unknown. We aimed to investigate the effects of intraoperative and postoperative ventilatory management in patients scheduled for abdominal surgery, compared with standard protective ventilation. Methods We did this prospective, multicentre, randomised controlled trial in 21 teaching hospitals in Spain. We enrolled patients who were aged 18 years or older, were scheduled to have abdominal surgery with an expected time of longer than 2 h, had intermediate-to-high-risk of developing postoperative pulmonary complications, and who had a body-mass index less than 35 kg/m(2). Patients were randomly assigned (1: 1: 1: 1) online to receive one of four lung-protective ventilation strategies using low tidal volume plus positive end-expiratory pressure (PEEP): open-lung approach (OLA)-iCPAP (individualised intraoperative ventilation [individualised PEEP after a lung recruitment manoeuvre] plus individualised postoperative continuous positive airway pressure [CPAP]), OLA-CPAP (intraoperative individualised ventilation plus postoperative CPAP), STD-CPAP (standard intraoperative ventilation plus postoperative CPAP), or STD-O-2 (standard intraoperative ventilation plus standard postoperative oxygen therapy). Patients were masked to treatment allocation. Investigators were not masked in the operating and postoperative rooms; after 24 h, data were given to a second investigator who was masked to allocations. The primary outcome was a composite of pulmonary and systemic complications during the first 7 postoperative days. We did the primary analysis using the modified intention-to-treat population. This trial is registered with ClinicalTrials.gov, number NCT02158923. Findings Between Jan 2, 2015, and May 18, 2016, we enrolled 1012 eligible patients. Data were available for 967 patients, whom we included in the final analysis. Risk of pulmonary and systemic complications did not differ for patients in OLA-iCPAP (110 [46%] of 241, relative risk 0.89 [95% CI 0.74-1.07; p=0.25]), OLA-CPAP (111 [47%] of 238, 0.91 [0.76-1.09; p=0.35]), or STD-CPAP groups (118 [48%] of 244, 0.95 [0.80-1.14; p=0.65]) when compared with patients in the STD-O-2 group (125 [51%] of 244). Intraoperatively, PEEP was increased in 69 (14%) of patients in the standard perioperative ventilation groups because of hypoxaemia, and no patients from either of the OLA groups required rescue manoeuvres. Interpretation In patients who have major abdominal surgery, the different perioperative open lung approaches tested in this study did not reduce the risk of postoperative complications when compared with standard lung-protective mechanical ventilation.
- Published
- 2018