Portal de investigación
Individualised perioperative open-lung approach versus standard protective ventilation in abdominal surgery (iPROVE): a randomised controlled trial
Autores de IIS La Fe
Participantes ajenos a IIS La Fe
- 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
- 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
- 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
- Individualized PeRioperative Open-lung VEntilation (iPROVE) Network
Grupos
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.
Datos de la publicación
- ISSN/ISSNe:
- 2213-2600, 2213-2619
- Tipo:
- Article
- Páginas:
- 193-203
- Factor de Impacto:
- 7,695 SCImago ℠
- Cuartil:
- Q1 SCImago ℠
LANCET RESPIRATORY MEDICINE ELSEVIER SCI LTD
Citas Recibidas en Web of Science: 118
Documentos
- No hay documentos
Filiaciones
Keywords
- POSTOPERATIVE PULMONARY COMPLICATIONS; LOW-TIDAL-VOLUME; MECHANICAL VENTILATION; GENERAL-ANESTHESIA; PRESSURE; METAANALYSIS; HYPOXEMIA
Proyectos asociados
EFECTO CLÍNICO DE LA PREPARACIÓN FOLICULAR CON TESTOSTERONA EN BAJA RESPUESTA OVÁRICA: ENSAYO CLÍNICO RANDOMIZADO Y CONTROLADO.
Investigador Principal: JESSICA SUBIRÁ NADAL
TESTOPRIM . 2017
REDUCCIÓN DE LA INFECCIÓN DE HERIDA QUIRÚRGICA CON UNA ESTRATEGIA PERIOPERATORIA INDIVIDUALIZADA DE VENTILACIÓN DE PROTECCIÓN PULMONAR CON FRACCIÓN INSPIRATORIA DE OXÍGENO ELEVADA. ESTUDIO COMPARATIVO, PROSPECTIVO, MULTICÉNTRICO, ALEATORIZADO Y CONTROLADO .
Investigador Principal: ÓSCAR DÍAZ CAMBRONERO
IPROVE-O2 . 2017
INDIVIDUALIZED PERIOPERATIVE HEMODYNAMIC GOAL-DIRECTED THERAPY IN MAJOR ABDOMINAL SURGERY (IPEGASUS-TRIAL).
Investigador Principal: ÓSCAR DÍAZ CAMBRONERO
IPEGASUS . 2017
BLOQUEO NEUROMUSCULAR RESIDUAL POSTOPERATORIO CERO (PORCZERO).
Investigador Principal: GUIDO MAZZINARI
CEO-SUG-2016-01 . 2018
PRESIÓN INDIVIDUALIZADA DE INSUFLACIÓN DEL PNEUMOPERITONEO EN CIRUGÍA LAPAROSCÓPICA COLORECTAL FRENTE A TERAPIA ESTÁNDAR.
Investigador Principal: ÓSCAR DÍAZ CAMBRONERO
IPPCOLLAPSE-II . 2016
ESTUDIO TRANSVERSAL DE LA INCIDENCIA DE BLOQUEO NEUROMUSCULAR RESIDUAL (BNMR) EN PACIENTES ADULTOS EN LOS HOSPITALES ESPAÑOLES.
Investigador Principal: ÓSCAR DÍAZ CAMBRONERO
CEO-BNM-2014-01
REDUCCIÓN DE LAS COMPLICACIONES POSTOPERATORIAS Y DE LA ESTANCIA HOSPITALARIA CON UNA ESTRATEGIA PERIOPERATORIA INDIVIDUALIZADA DE VENTILACIÓN DE PROTECCIÓN PULMONAR. ESTUDIO COMPARATIVO, PROSPECTIVO, MULTICÉNTRICO, ALEATORIZADO Y CONTROLADO.
Investigador Principal: ÓSCAR DÍAZ CAMBRONERO
IPROVE . 2015
EVALUACIÓN DE LOS NIVELES PLASMÁTICOS DE HEPCIDINA EN PACIENTES CON ANEMIA FERROPÉNICA Y CÁNCER COLORECTAL.
Investigador Principal: MARÍA VILA MONTAÑÉS
MAR-HIE-2015-01
DIFUSIÓN DEL ANESTÉSICO LOCAL EN EL ESPACIO PARAVERTEBRAL TORÁCICO TRAS BLOQUEO PARAVERTEBRAL: ESTUDIO CON TOMOGRAFÍA COMPUTERIZADA CONE BEAM.
Investigador Principal: NURIA GARCÍA GREGORIO
NUR-ROP-2015-01
Cita
Ferrando C,Soro M,Unzueta C,Suarez F,Canet J,Librero J,Pozo N,Peiro S,Llombart A,Leon I,India I,Aldecoa C,Diaz 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 S,Valdivia J,Hernandez MJ,Padron O,Colas A,Puig J,Azparren G,Tusman G,Villar J,Belda J,Individualized PeRioperative Open N. Individualised perioperative open-lung approach versus standard protective ventilation in abdominal surgery (iPROVE): a randomised controlled trial. Lancet Respir Med. 2018. 6. (3):p. 193-203. IF:22,992. (1).