Rationale and study design for an individualized perioperative open lung ventilatory strategy (iPROVE): study protocol for a randomized controlled trial.
BACKGROUND
Postoperative pulmonary and non-pulmonary complications are common problems that increase morbidity and mortality in surgical patients, even though the incidence has decreased with the increased use of protective lung ventilation strategies. Previous trials have focused on standard strategies in the intraoperative or postoperative period, but without personalizing these strategies to suit the needs of each individual patient and without considering both these periods as a global perioperative lung-protective approach. The trial presented here aims at comparing postoperative complications when using an individualized ventilatory management strategy in the intraoperative and immediate postoperative periods with those when using a standard protective ventilation strategy in patients scheduled for major abdominal surgery.


METHODS
This is a comparative, prospective, multicenter, randomized, and controlled, four-arm trial that will include 1012 patients with an intermediate or high risk for postoperative pulmonary complications. The patients will be divided into four groups: (1) individualized perioperative group: intra- and postoperative individualized strategy; (2) intraoperative individualized strategy + postoperative continuous positive airway pressure (CPAP); (3) intraoperative standard ventilation + postoperative CPAP; (4) intra- and postoperative standard strategy (conventional strategy). The primary outcome is a composite analysis of postoperative complications.


CONCLUSIONS
The Individualized Perioperative Open-lung Ventilatory Strategy (iPROVE) is the first multicenter, randomized, and controlled trial to investigate whether an individualized perioperative approach prevents postoperative pulmonary complications.


BACKGROUND
Registered on 5 June 2014 with identification no. NCT02158923 .
Anesthesiology and Critical Care Department, Hospital Clínico of Valencia, Av. Blasco Ibañez, 17, Valencia, CP: 46010, Spain. cafeoranestesia@gmail.com.
Carlos
C
Ferrando
Anesthesiology and Critical Care Department, Hospital Clínico of Valencia, Av. Blasco Ibañez, 17, Valencia, CP: 46010, Spain. soromarina@gmail.com.
Marina
M
Soro
Anesthesiology and Critical Care Department, Hospital Germans Tries i Pujol, Carretera de Canyet s/n, 08916, Badalona, Spain. jcanet54@gmail.es.
Jaume
J
Canet
Anesthesiology and Critical Care Department, Hospital San Pau, Carrer de Sant Quintí, 89, CP: 08026, Barcelona, Spain. mcunzueta@gmail.com.
Ma Carmen
MC
Unzueta
Intensive Care Department, Uppsala University Hospital, Suecia Akademiska Sjukhuset Uppsala University, CP: 75185, Uppsala, Sweden. fsuarez.sipmann@surgsci.uu.se.
Fernando
F
Suárez
FISABIO salud Pública, Av. Cataluña, 21, CP: 46020, Valencia, Spain. librero_jul@gva.es.
Julián
J
Librero
FISABIO salud Pública, Av. Cataluña, 21, CP: 46020, Valencia, Spain. peiro_bor@gva.es.
Salvador
S
Peiró
Anesthesiology and Critical Care Department, Hospital Clínico of Valencia, Av. Blasco Ibañez, 17, Valencia, CP: 46010, Spain. allombart@incliva.es.
Alicia
A
Llombart
Anesthesiology and Critical Care Department, Hospital Clínico of Valencia, Av. Blasco Ibañez, 17, Valencia, CP: 46010, Spain. cardelna@gmail.com.
Carlos
C
Delgado
Anesthesiology and Critical Care Department, Hospital Clínico of Valencia, Av. Blasco Ibañez, 17, Valencia, CP: 46010, Spain. irene.leon.carsi@gmail.com.
Irene
I
León
Anesthesiology and Critical Care Department, Hospital de Manises, Av. De la Generalitat Valenciana, Manises, CP: 46940, Spain. lucasrovira@gmail.com.
Lucas
L
Rovira
Anesthesiology and Critical Care Department, Hospital La Princesa of Madrid, Calle de Diego León, 62, CP: 28006, Madrid, Spain. gorria66@gmail.com.
Fernando
F
Ramasco
Anesthesiology and Critical Care Department, Hospital General of Valencia, Av. De les Tres Creus, 2, Valencia, CP: 46014, Spain. mgranellg@gmail.com.
Manuel
M
Granell
Anesthesiology and Critical Care Department, Hospital Río Hortega of Valladolid, Calle Dulzaina, 2, Valladolid, CP 47012, Spain. cesar.aldecoa@gmail.com.
César
C
Aldecoa
Anesthesiology and Critical Care Department, Hospital La Fe of Valencia, Av. De Fernando Abril Martorell, 106, Valencia, CP: 46026, Spain. oscardiazcambronero@gmail.com.
Oscar
O
Diaz
Anesthesiology and Critical Care Department, Hospital Clínic i Provincial of Barcelona, Carrer Villarroel 170, Barcelona, CP: 08036, Spain. jbalust@clinic.ub.es.
Jaume
J
Balust
Anesthesiology and Critical Care Department, Hospital General Gregorio Marañon of Madrid, Calle del Doctor Esquerdo, 46, Madrid, CP: 28007, Spain. ngaruttimartinez@yahoo.es.
Ignacio
I
Garutti
Anesthesiology and Critical Care Department, Hospital Vírgen del Rocio of Sevilla, Av. Manuel Siurot s/n, Sevilla, CP: 41013, Spain. mdlmatta@hotmail.com.
Manuel
M
de la Matta
Anesthesiology and Critical Care Department, Complejo Hospitalario Juan Canalejo of La Coruña, Xubias, 84, La Coruña, CP: 15006, Spain. Teresa.Alonso.Ferreira@sergas.es.
Alberto
A
Pensado
Anesthesiology and Critical Care Department, Hospital of León, C/ Altos de Nava s/n, Leon, CP: 24701, Spain. rafarealeon@gmail.com.
Rafael
R
Gonzalez
Anesthesiology and Critical Care Department, Hospital Vírgen de la Arraixaca of Murcia, Carretera de Madrid-Cartagena s/n, Madrird, CP: 30120, Spain. geniaduran@gmail.com.
M Eugenia
ME
Durán
Anesthesiology and Critical Care Department, Hospital Miguel Servet of Zaragoza, Paseo Isabel la Católica, 1-3, Zaragoza, CP: 50009, Spain. lgallegoligorit@gmail.com.
Lucia
L
Gallego
Anesthesiology and Critical Care Department, Hospital Fundación of Alcorcón, Calle de Valdelaguna, 1, Alcorcón, CP: 28922, Spain. sgarcia@anestesiar.org.
Santiago García
SG
Del Valle
Anesthesiology and Critical Care Department, Hospital General of Ciudad Real, C/ Alisos, 19, Ciudad Real, CP: 13002, Spain. ardredondo@hotmail.com.
Francisco J
FJ
Redondo
Anesthesiology and Critical Care Department, Hospital de Valme of Sevilla, Av. Bellavista s/n, Sevilla, CP: 41014, Spain. d_spedro@hotmail.com.
Pedro
P
Diaz
Anesthesiology and Critical Care Department, Hospital Ramón y Cajal of Madrid, Carretera de Colmenar Viejo Km 9, Madrid, CP: 28034, Spain. dpestanalag@hotmail.com.
David
D
Pestaña
Anesthesiology and Critical Care Department, Hospital de Gran Canaria Dr. Negrín, c/ Barranco de la Ballena s/n, Negrin, CP: 35010, Spain. arodperp@gobiernodecanarias.org.
Aurelio
A
Rodríguez
Anesthesiology and Critical Care Department, Hospital of Galdakano, Barrio Labeaga s/n, Galdakano, CP: 48960, Spain. javier.aguirrearas@osakidetza.net.
Javier
J
Aguirre
Anesthesiology and Critical Care Department, Complejo Hospitalario Juan Ramón Jimenez of Huelva, Ronda exterior norte, s/n, Huelva, CP: 21005, Spain. JMGG1982BOLLU@hotmail.com.
Jose M
JM
García
Anesthesiology and Critical Care Department, Hospital Puerta de Hierro of Majadahonda, C/ Manuel de Falla, 1, Majadahonda, CP: 28222, Spain. ventilacionanestesia@gmail.com.
Javier
J
García
Anesthesiology and Critical Care Department, Hospital Nuestra Señora de la Candelaria of Santa Cruz de Tenerife, Carretera del Rosario, 145, Santa Cruz de Tenerife, CP: 38010, Spain. mespdom@gmail.com.
Elena
E
Espinosa
Anesthesiology and Critical Care Department, Hospital Son Espases of Mallorca, Carretera de la Valldemosa, 79, Mallorca, CP: 07120, Spain. pcharco@gmail.com.
Pedro
P
Charco
Anesthesiology and Critical Care Department, Hospital General of Alicante, Pintor Baeza, 12, Alicante, CP: 03010, Spain. jnavarro.martinez@gmail.com.
Jose
J
Navarro
FISABIO salud Pública, Av. Cataluña, 21, CP: 46020, Valencia, Spain. rodriguez_claber@gva.es.
Clara
C
Rodríguez
Anesthesiology Department, Hospital Privado de Comunidad Mar de Plata, Mar de Plata, Argentina. gtusman@hotmail.com.
Gerardo
G
Tusman
Anesthesiology and Critical Care Department, Hospital Clínico of Valencia, Av. Blasco Ibañez, 17, Valencia, CP: 46010, Spain. fco.javier.belda@uv.es.
Francisco Javier
FJ
Belda
D000005:Abdomen / Q000601:surgery*; D002985:Clinical Protocols; D045422:Continuous Positive Airway Pressure / Q000009:adverse effects; D005260:Female; D006801:Humans; D008168:Lung / Q000503:physiopathology*; D008171:Lung Diseases / Q000175:diagnosis / Q000209:etiology / Q000503:physiopathology / Q000517:prevention & control*; D008297:Male; D019990:Perioperative Care; D011183:Postoperative Complications / Q000175:diagnosis / Q000503:physiopathology / Q000517:prevention & control*; D011446:Prospective Studies; D012107:Research Design; D012121:Respiration, Artificial / Q000009:adverse effects / Q000379:methods*; D013030:Spain; D013997:Time Factors; D016896:Treatment Outcome