Individualised perioperative open-lung approach versus standard protective ventilation in abdominal surgery (iPROVE): a randomised controlled trial
Por:
Ferrando, C, Soro, M, Unzueta, C, Suarez-Sipmann, F, Canet, J, Librero, J, Pozo, N, Peiro, S, Llombart, A, Leon, I, India, I, Aldecoa, C, Diaz-Cambronero, O, Pestana, D, Redondo, FJ, Garutti, I, Balust, J, Garcia, JI, Ibanez, M, Granell, M, Rodriguez, A, Gallego, L, de la Matta, M, Gonzalez, R, Brunelli, A, Garcia, J, Rovira, L, Barrios, F, Torres, V, Hernandez, S, Gracia, E, Gine, M, Garcia, M, Garcia, N, Miguel, L, Sanchez, S, Pineiro, P, Pujol, R, Garcia-del-Valle, S, Valdivia, J, Hernandez, MJ, Padron, O, Colas, A, Puig, J, Azparren, G, Tusman, G, Villar, J, Belda, J
Publicada:
1 mar 2018
Resumen:
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.
Filiaciones:
Ferrando, C:
Hosp Clin Univ, Dept Anesthesiol & Crit Care, Valencia 46010, Spain
Inst Salud Carlos III, CIBER Enfermedades Resp, Madrid, Spain
Unzueta, C:
Hosp Univ Sant Pau, Dept Anesthesiol & Crit Care, Barcelona, Spain
Suarez-Sipmann, F:
Inst Salud Carlos III, CIBER Enfermedades Resp, Madrid, Spain
Univ Uppsala Hosp, Dept Surg Sci, Hedenstierna Lab, Uppsala, Sweden
Canet, J:
Hosp Univ Germans Tries & Pujol, Dept Anesthesiol & Crit Care, Badalona, Spain
Librero, J:
REDISSEC, Navarrabiomed Fdn Miguel Servet, Pamplona, Spain
Pozo, N:
Hosp Clin Univ Valencia, INCLIVA Clin Res Inst, Valencia, Spain
Peiro, S:
REDISSEC, CSISP FISABIO, Valencia, Spain
Llombart, A:
Hosp Univ Politecn Fe, IISLAFE Clin Res Inst, Valencia, Spain
Leon, I:
Hosp Clin Univ, Dept Anesthesiol & Crit Care, Valencia 46010, Spain
India, I:
Hosp Univ Sant Pau, Dept Anesthesiol & Crit Care, Barcelona, Spain
Aldecoa, C:
Hosp Univ Rio Hortega, Dept Anesthesiol & Crit Care, Valladolid, Spain
Diaz-Cambronero, O:
Hosp Univ Politecn Fe, Dept Anesthesiol & Crit Care, Valencia, Spain
Pestana, D:
Hosp Univ Ramon & Cajal, Dept Anesthesiol & Crit Care, Madrid, Spain
Redondo, FJ:
Hosp Gen Univ Ciudad Real, Dept Anesthesiol & Crit Care, Ciudad Real, Spain
Garutti, I:
Hosp Gen Univ Gregorio Maranon, Dept Anesthesiol & Crit Care, Madrid, Spain
Balust, J:
Hosp Clin & Prov Univ, Dept Anesthesiol & Crit Care, Barcelona, Spain
Garcia, JI:
Hosp Clin Univ, Dept Anesthesiol & Crit Care, Valencia 46010, Spain
Hosp Univ Politecn Fe, Dept Anesthesiol & Crit Care, Valencia, Spain
Hosp Fdn Alcorcon, Dept Anesthesiol & Crit Care, Alcorcon, Spain
Hosp Univ Puerta Hierro, Dept Anesthesiol & Crit Care, Madrid, Spain
Ibanez, M:
Hosp Marina Baixa Vila Joiosa, Dept Anesthesiol, Alicante, Spain
Granell, M:
Hosp Gen Univ, Dept Anesthesiol & Crit Care, Valencia, Spain
Rodriguez, A:
Hosp Univ Doctor Negrin, Dept Anesthesiol, Las Palmas Gran Canaria, Spain
Gallego, L:
Hosp Univ Miguel Servet, Dept Anesthesiol & Crit Care, Zaragoza, Spain
de la Matta, M:
Hosp Univ Virgen Rocio, Dept Anesthesiol & Crit Care, Seville, Spain
Gonzalez, R:
Hosp Univ Leon, Dept Anesthesiol, Leon, Spain
Brunelli, A:
Hosp Univ Germans Tries & Pujol, Dept Anesthesiol & Crit Care, Badalona, Spain
Garcia, J:
Hosp Clin Univ, Dept Anesthesiol & Crit Care, Valencia 46010, Spain
Hosp Univ Politecn Fe, Dept Anesthesiol & Crit Care, Valencia, Spain
Hosp Fdn Alcorcon, Dept Anesthesiol & Crit Care, Alcorcon, Spain
Hosp Univ Puerta Hierro, Dept Anesthesiol & Crit Care, Madrid, Spain
Rovira, L:
Hosp Manises, Dept Anesthesiol, Valencia, Spain
Barrios, F:
Hosp Principe Asturias Madrid, Dept Anesthesiol & Crit Care, Madrid, Spain
Torres, V:
Hosp Son Espases, Dept Anesthesiol & Crit Care, Palma de Mallorca, Spain
Hernandez, S:
Hosp NS Candelaria, Dept Anesthesiol, Santa Cruz de Tenerife, Spain
Gine, M:
Hosp Univ Sant Pau, Dept Anesthesiol & Crit Care, Barcelona, Spain
Garcia, M:
Hosp Univ Rio Hortega, Dept Anesthesiol & Crit Care, Valladolid, Spain
Pujol, R:
Hosp Clin & Prov Univ, Dept Anesthesiol & Crit Care, Barcelona, Spain
Garcia-del-Valle, S:
Hosp Fdn Alcorcon, Dept Anesthesiol & Crit Care, Alcorcon, Spain
Valdivia, J:
Hosp Marina Baixa Vila Joiosa, Dept Anesthesiol, Alicante, Spain
Hernandez, MJ:
Hosp Gen Univ, Dept Anesthesiol & Crit Care, Valencia, Spain
Padron, O:
Hosp Univ Doctor Negrin, Dept Anesthesiol, Las Palmas Gran Canaria, Spain
Colas, A:
Hosp Univ Miguel Servet, Dept Anesthesiol & Crit Care, Zaragoza, Spain
Puig, J:
Hosp Clin Univ, Dept Anesthesiol & Crit Care, Valencia 46010, Spain
Azparren, G:
Hosp Univ Sant Pau, Dept Anesthesiol & Crit Care, Barcelona, Spain
Tusman, G:
Hosp Privado Comunidad Mar Plata, Dept Anesthesiol, Mar Del Plata, Buenos Aires, Argentina
Villar, J:
Hosp Univ Doctor Negrin, Multidisciplinary Organ Dysfunct Evaluat Res Netw, Las Palmas Gran Canaria, Spain
Belda, J:
Hosp Clin Univ, Dept Anesthesiol & Crit Care, Valencia 46010, Spain
Univ Valencia, Dept Surg, Valencia, Spain
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