Randomized Controlled Trial Multicenter Study
- Carlos Ferrando, Marina Soro, Carmen Unzueta, Fernando Suarez-Sipmann, Jaume Canet, Julián Librero, Natividad Pozo, Salvador Peiró, Alicia Llombart, Irene León, Inmaculada India, Cesar Aldecoa, Oscar Díaz-Cambronero, David Pestaña, Francisco J Redondo, Ignacio Garutti, Jaume Balust, Jose I García, Maite Ibáñez, Manuel Granell, Aurelio Rodríguez, Lucía Gallego, Manuel de la Matta, Rafael Gonzalez, Andrea Brunelli, Javier García, Lucas Rovira, Francisco Barrios, Vicente Torres, Samuel Hernández, Estefanía Gracia, Marta Giné, María García, Nuria García, Lisset Miguel, Sergio Sánchez, Patricia Piñeiro, Roger Pujol, Santiago García-Del-Valle, José Valdivia, María J Hernández, Oto Padrón, Ana Colás, Jaume Puig, Gonzalo Azparren, Gerardo Tusman, Jesús Villar, Javier Belda, and Individualized PeRioperative Open-lung VEntilation (iPROVE) Network.
- Department of Anesthesiology & Critical Care, Hospital Clínico Universitario, Valencia, Spain; CIBER de Enfermedades Respiratorias, Instituto de Salud Carlos III, Madrid, Spain. Electronic address: firstname.lastname@example.org.
- Lancet Respir Med. 2018 Mar 1; 6 (3): 193-203.
BackgroundThe 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.MethodsWe 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/m2. 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-O2 (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.FindingsBetween 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-O2 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.InterpretationIn 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.FundingInstituto de Salud Carlos III of the Spanish Ministry of Economy and Competitiveness, and Grants Programme of the European Society of Anaesthesiology.Copyright © 2018 Elsevier Ltd. All rights reserved.
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