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Trials. 2015 Apr 27;16:193. doi: 10.1186/s13063-015-0694-1.

Rationale and study design for an individualized perioperative open lung ventilatory strategy (iPROVE): study protocol for a randomized controlled trial.

Collaborators (142)

Ferrando C, Belda J, Soro M, Canet J, Unzueta C, Suárez F, Librero J, Llombart A, Ferrando C, Canet J, Unzueta MC, Rovira L, Ramasco F, Granell M, Aldecoa C, Diaz O, Balust J, Garutti I, Alonso T, Gonzalez R, Durán ME, Gallego L, Redondo J, Diaz P, Pestaña D, Rodríguez A, Hernandez M, García J, Espinosa E, Charco P, de la Matta M, Ibáñez M, Barrios F, Villar J, Borges J, Jaber S, Ferrando C, Llombart A, Soro M, Delgado C, Peiró S, Romero E, Romero C, Miñana A, Moreno T, Katime A, Gracia E, Izquierdo A, Socorro T, Rubio C, Valls P, Lozano A, Duca A, Incertis R, Fuentes I, Jurado A, Carrizo J, Navarro J, Villena A, Serralta F, Carbonell JA, Puig J, Arocas B, García ML, Gutierrez A, Aguilar G, Mugarra A, Alonso JM, Parra MJ, de Fez M, Nieves J, Alvarez C, Tolos R, Sendra M, Brunelli A, García M, Azparren G, Piñeiro P, Lajara A, Pérez JM, de Andrés JA, Hernández MJ, Gómez L, Alonso T, Rodiño S, López M, Pérez AM, Marcos JM, Díez F, Martínez MP, del Mar Hernández M, Fernandez-Pacheco J, Rivera MJ, Galiana M, Colás A, Molinós I, Asensio A, Vergas M, García C, Rico J, García P, García JI, Varón V, Romero E, Mazzinari G, Herrera E, Rosado E, Ramos P, Ojeda N, Padrón O, Cabrera S, Rodríguez R, Romero A, González A, García J, de Castro NM, Medrano C, Mané N, Martínez G, Pujol R, Alcon A, Torres V, García JR, Dominguez A, Benítez I, González D, López-Herrera D, Hernández M, Morales C, Soriano D, Domínguez D, Hernández S, Vila M, Alberola MJ, Verdeguer S, Ibáñez M, Lozano E, Valdivia J, Gilabert V, Barrios F, Ayuso M, Moreno R.

Author information

1
Anesthesiology and Critical Care Department, Hospital Clínico of Valencia, Av. Blasco Ibañez, 17, Valencia, CP: 46010, Spain. cafeoranestesia@gmail.com.
2
Anesthesiology and Critical Care Department, Hospital Clínico of Valencia, Av. Blasco Ibañez, 17, Valencia, CP: 46010, Spain. soromarina@gmail.com.
3
Anesthesiology and Critical Care Department, Hospital Germans Tries i Pujol, Carretera de Canyet s/n, 08916, Badalona, Spain. jcanet54@gmail.es.
4
Anesthesiology and Critical Care Department, Hospital San Pau, Carrer de Sant Quintí, 89, CP: 08026, Barcelona, Spain. mcunzueta@gmail.com.
5
Intensive Care Department, Uppsala University Hospital, Suecia Akademiska Sjukhuset Uppsala University, CP: 75185, Uppsala, Sweden. fsuarez.sipmann@surgsci.uu.se.
6
FISABIO salud Pública, Av. Cataluña, 21, CP: 46020, Valencia, Spain. librero_jul@gva.es.
7
FISABIO salud Pública, Av. Cataluña, 21, CP: 46020, Valencia, Spain. peiro_bor@gva.es.
8
Anesthesiology and Critical Care Department, Hospital Clínico of Valencia, Av. Blasco Ibañez, 17, Valencia, CP: 46010, Spain. allombart@incliva.es.
9
Anesthesiology and Critical Care Department, Hospital Clínico of Valencia, Av. Blasco Ibañez, 17, Valencia, CP: 46010, Spain. cardelna@gmail.com.
10
Anesthesiology and Critical Care Department, Hospital Clínico of Valencia, Av. Blasco Ibañez, 17, Valencia, CP: 46010, Spain. irene.leon.carsi@gmail.com.
11
Anesthesiology and Critical Care Department, Hospital de Manises, Av. De la Generalitat Valenciana, Manises, CP: 46940, Spain. lucasrovira@gmail.com.
12
Anesthesiology and Critical Care Department, Hospital La Princesa of Madrid, Calle de Diego León, 62, CP: 28006, Madrid, Spain. gorria66@gmail.com.
13
Anesthesiology and Critical Care Department, Hospital General of Valencia, Av. De les Tres Creus, 2, Valencia, CP: 46014, Spain. mgranellg@gmail.com.
14
Anesthesiology and Critical Care Department, Hospital Río Hortega of Valladolid, Calle Dulzaina, 2, Valladolid, CP 47012, Spain. cesar.aldecoa@gmail.com.
15
Anesthesiology and Critical Care Department, Hospital La Fe of Valencia, Av. De Fernando Abril Martorell, 106, Valencia, CP: 46026, Spain. oscardiazcambronero@gmail.com.
16
Anesthesiology and Critical Care Department, Hospital Clínic i Provincial of Barcelona, Carrer Villarroel 170, Barcelona, CP: 08036, Spain. jbalust@clinic.ub.es.
17
Anesthesiology and Critical Care Department, Hospital General Gregorio Marañon of Madrid, Calle del Doctor Esquerdo, 46, Madrid, CP: 28007, Spain. ngaruttimartinez@yahoo.es.
18
Anesthesiology and Critical Care Department, Hospital Vírgen del Rocio of Sevilla, Av. Manuel Siurot s/n, Sevilla, CP: 41013, Spain. mdlmatta@hotmail.com.
19
Anesthesiology and Critical Care Department, Complejo Hospitalario Juan Canalejo of La Coruña, Xubias, 84, La Coruña, CP: 15006, Spain. Teresa.Alonso.Ferreira@sergas.es.
20
Anesthesiology and Critical Care Department, Hospital of León, C/ Altos de Nava s/n, Leon, CP: 24701, Spain. rafarealeon@gmail.com.
21
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.
22
Anesthesiology and Critical Care Department, Hospital Miguel Servet of Zaragoza, Paseo Isabel la Católica, 1-3, Zaragoza, CP: 50009, Spain. lgallegoligorit@gmail.com.
23
Anesthesiology and Critical Care Department, Hospital Fundación of Alcorcón, Calle de Valdelaguna, 1, Alcorcón, CP: 28922, Spain. sgarcia@anestesiar.org.
24
Anesthesiology and Critical Care Department, Hospital General of Ciudad Real, C/ Alisos, 19, Ciudad Real, CP: 13002, Spain. ardredondo@hotmail.com.
25
Anesthesiology and Critical Care Department, Hospital de Valme of Sevilla, Av. Bellavista s/n, Sevilla, CP: 41014, Spain. d_spedro@hotmail.com.
26
Anesthesiology and Critical Care Department, Hospital Ramón y Cajal of Madrid, Carretera de Colmenar Viejo Km 9, Madrid, CP: 28034, Spain. dpestanalag@hotmail.com.
27
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.
28
Anesthesiology and Critical Care Department, Hospital of Galdakano, Barrio Labeaga s/n, Galdakano, CP: 48960, Spain. javier.aguirrearas@osakidetza.net.
29
Anesthesiology and Critical Care Department, Complejo Hospitalario Juan Ramón Jimenez of Huelva, Ronda exterior norte, s/n, Huelva, CP: 21005, Spain. JMGG1982BOLLU@hotmail.com.
30
Anesthesiology and Critical Care Department, Hospital Puerta de Hierro of Majadahonda, C/ Manuel de Falla, 1, Majadahonda, CP: 28222, Spain. ventilacionanestesia@gmail.com.
31
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.
32
Anesthesiology and Critical Care Department, Hospital Son Espases of Mallorca, Carretera de la Valldemosa, 79, Mallorca, CP: 07120, Spain. pcharco@gmail.com.
33
Anesthesiology and Critical Care Department, Hospital General of Alicante, Pintor Baeza, 12, Alicante, CP: 03010, Spain. jnavarro.martinez@gmail.com.
34
FISABIO salud Pública, Av. Cataluña, 21, CP: 46020, Valencia, Spain. rodriguez_claber@gva.es.
35
Anesthesiology Department, Hospital Privado de Comunidad Mar de Plata, Mar de Plata, Argentina. gtusman@hotmail.com.
36
Anesthesiology and Critical Care Department, Hospital Clínico of Valencia, Av. Blasco Ibañez, 17, Valencia, CP: 46010, Spain. fco.javier.belda@uv.es.

Abstract

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.

DISCUSSION:

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.

TRIAL REGISTRATION:

Registered on 5 June 2014 with identification no. NCT02158923 .

PMID:
25927183
PMCID:
PMC4425893
DOI:
10.1186/s13063-015-0694-1
[Indexed for MEDLINE]
Free PMC Article

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