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

Carlos Ferrando, Marina Soro, Jaume Canet, Ma Carmen Unzueta, Fernando Suárez, Julián Librero, Salvador Peiró, Alicia Llombart, Carlos Delgado, Irene León, Lucas Rovira, Fernando Ramasco, Manuel Granell, César Aldecoa, Oscar Diaz, Jaume Balust, Ignacio Garutti, Manuel de la Matta, Alberto Pensado, Rafael Gonzalez, M Eugenia Durán, Lucia Gallego, Santiago García Del Valle, Francisco J Redondo, Pedro Diaz, David Pestaña, Aurelio Rodríguez, Javier Aguirre, Jose M García, Javier García, Elena Espinosa, Pedro Charco, Jose Navarro, Clara Rodríguez, Gerardo Tusman, Francisco Javier Belda, iPROVE investigators (Appendices 1 and 2), Carlos Ferrando, Javier Belda, Marina Soro, Jaume Canet, Carmen Unzueta, Fernando Suárez, Julián Librero, Alicia Llombart, Carlos Ferrando, Jaume Canet, Ma Carmen Unzueta, Lucas Rovira, Fernando Ramasco, Manuel Granell, César Aldecoa, Oscar Diaz, Jaume Balust, Ignacio Garutti, Teresa Alonso, Rafael Gonzalez, Ma Eugenia Durán, Lucia Gallego, Javier Redondo, Pedro Diaz, David Pestaña, Aurelio Rodríguez, Marisol Hernandez, Javier García, Elena Espinosa, Pedro Charco, Manuel de la Matta, Maite Ibáñez, Francisco Barrios, Jesus Villar, Joao Borges, Samir Jaber, Carlos Ferrando, Alicia Llombart, Marina Soro, Carlos Delgado, Salvador Peiró, Esther Romero, Carolina Romero, Amanda Miñana, Tania Moreno, Antonio Katime, Estefanía Gracia, Ana Izquierdo, Tania Socorro, Concepción Rubio, Paola Valls, Angels Lozano, Alejandro Duca, Raul Incertis, Isabel Fuentes, Ana Jurado, Juan Carrizo, Jose Navarro, Abigail Villena, Ferran Serralta, Jose A Carbonell, Jaume Puig, Blanca Arocas, Ma Luisa García, Andrea Gutierrez, Gerardo Aguilar, Ana Mugarra, Jose M Alonso, Maria J Parra, Mario de Fez, Jesus Nieves, Carlos Alvarez, Raquel Tolos, Mar Sendra, Andrea Brunelli, Mercedes García, Gonzalo Azparren, Patricia Piñeiro, AnaM Lajara, Jose M Pérez, Jose A de Andrés, Maria J Hernández, Lorena Gómez, Teresa Alonso, Sara Rodiño, Marta López, Ana M Pérez, Jose M Marcos, Fernando Díez, Ma Piedad Martínez, Ma del Mar Hernández, José Fernandez-Pacheco, Maria J Rivera, M Galiana, Ana Colás, Irene Molinós, Ana Asensio, Margarita Vergas, Clara García, Jesus Rico, Pablo García, Jose I García, Viviana Varón, Eva Romero, Guido Mazzinari, Esperanza Herrera, Eva Rosado, Patricia Ramos, Nazario Ojeda, Oto Padrón, Sergio Cabrera, Rayco Rodríguez, Antonio Romero, Ana González, Jessica García, Nilda Martinez de Castro, Cristina Medrano, Nuria Mané, Graciela Martínez, Roger Pujol, Amalia Alcon, Vicente Torres, Javier Román Marta García, Alejandro Dominguez, Inmaculada Benítez, Domingo González, Daniel López-Herrera, M Sol Hernández, Clara Morales, David Soriano, David Domínguez, Samuel Hernández, Maria Vila, Maria J Alberola, Sandra Verdeguer, Maite Ibáñez, Elena Lozano, Jose Valdivia, Vicente Gilabert, Francisco Barrios, Mercedes Ayuso, Ricardo Moreno, Carlos Ferrando, Marina Soro, Jaume Canet, Ma Carmen Unzueta, Fernando Suárez, Julián Librero, Salvador Peiró, Alicia Llombart, Carlos Delgado, Irene León, Lucas Rovira, Fernando Ramasco, Manuel Granell, César Aldecoa, Oscar Diaz, Jaume Balust, Ignacio Garutti, Manuel de la Matta, Alberto Pensado, Rafael Gonzalez, M Eugenia Durán, Lucia Gallego, Santiago García Del Valle, Francisco J Redondo, Pedro Diaz, David Pestaña, Aurelio Rodríguez, Javier Aguirre, Jose M García, Javier García, Elena Espinosa, Pedro Charco, Jose Navarro, Clara Rodríguez, Gerardo Tusman, Francisco Javier Belda, iPROVE investigators (Appendices 1 and 2), Carlos Ferrando, Javier Belda, Marina Soro, Jaume Canet, Carmen Unzueta, Fernando Suárez, Julián Librero, Alicia Llombart, Carlos Ferrando, Jaume Canet, Ma Carmen Unzueta, Lucas Rovira, Fernando Ramasco, Manuel Granell, César Aldecoa, Oscar Diaz, Jaume Balust, Ignacio Garutti, Teresa Alonso, Rafael Gonzalez, Ma Eugenia Durán, Lucia Gallego, Javier Redondo, Pedro Diaz, David Pestaña, Aurelio Rodríguez, Marisol Hernandez, Javier García, Elena Espinosa, Pedro Charco, Manuel de la Matta, Maite Ibáñez, Francisco Barrios, Jesus Villar, Joao Borges, Samir Jaber, Carlos Ferrando, Alicia Llombart, Marina Soro, Carlos Delgado, Salvador Peiró, Esther Romero, Carolina Romero, Amanda Miñana, Tania Moreno, Antonio Katime, Estefanía Gracia, Ana Izquierdo, Tania Socorro, Concepción Rubio, Paola Valls, Angels Lozano, Alejandro Duca, Raul Incertis, Isabel Fuentes, Ana Jurado, Juan Carrizo, Jose Navarro, Abigail Villena, Ferran Serralta, Jose A Carbonell, Jaume Puig, Blanca Arocas, Ma Luisa García, Andrea Gutierrez, Gerardo Aguilar, Ana Mugarra, Jose M Alonso, Maria J Parra, Mario de Fez, Jesus Nieves, Carlos Alvarez, Raquel Tolos, Mar Sendra, Andrea Brunelli, Mercedes García, Gonzalo Azparren, Patricia Piñeiro, AnaM Lajara, Jose M Pérez, Jose A de Andrés, Maria J Hernández, Lorena Gómez, Teresa Alonso, Sara Rodiño, Marta López, Ana M Pérez, Jose M Marcos, Fernando Díez, Ma Piedad Martínez, Ma del Mar Hernández, José Fernandez-Pacheco, Maria J Rivera, M Galiana, Ana Colás, Irene Molinós, Ana Asensio, Margarita Vergas, Clara García, Jesus Rico, Pablo García, Jose I García, Viviana Varón, Eva Romero, Guido Mazzinari, Esperanza Herrera, Eva Rosado, Patricia Ramos, Nazario Ojeda, Oto Padrón, Sergio Cabrera, Rayco Rodríguez, Antonio Romero, Ana González, Jessica García, Nilda Martinez de Castro, Cristina Medrano, Nuria Mané, Graciela Martínez, Roger Pujol, Amalia Alcon, Vicente Torres, Javier Román Marta García, Alejandro Dominguez, Inmaculada Benítez, Domingo González, Daniel López-Herrera, M Sol Hernández, Clara Morales, David Soriano, David Domínguez, Samuel Hernández, Maria Vila, Maria J Alberola, Sandra Verdeguer, Maite Ibáñez, Elena Lozano, Jose Valdivia, Vicente Gilabert, Francisco Barrios, Mercedes Ayuso, Ricardo Moreno

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 .

Figures

Figure 1
Figure 1
Flow diagram of iPROVE. CPAP continuous positive airway pressure.
Figure 2
Figure 2
Alveolar recruitment maneuver and PEEP titration trial protocol. RM recruitment maneuver, Crs respiratory system compliance, PEEP positive end-expiratory pressure, CPAP continuous positive end-expiratory pressure, VCV volume-controlled ventilation, PCV pressure-controlled ventilation, RR respiratory rate, I:E inspiratory-to-expiratory ratio.

References

    1. Weiser TG, Regenbogen SE, Thompson KD, Haynes AB, Lipsitz SR, Berry WR, et al. An estimation of the global volume of surgery: a modelling strategy based on available data. Lancet. 2008;372:139–44. doi: 10.1016/S0140-6736(08)60878-8.
    1. Khuri SF, Henderson WG, DePalma RG, Mosca C, Healey NA, Kumbhani DJ. Participants in the VA National Surgical Quality Improvement Program. Determinants of long-term survival after major surgery and the adverse effect of postoperative complications. Ann Surg. 2005;242:326–41.
    1. Warner DO. Preventing postoperative pulmonary complications: the role of the anesthesiologist. Anesthesiology. 2000;92:1467–72. doi: 10.1097/00000542-200005000-00037.
    1. Brooks-Brunn JA. Postoperative atelectasis and pneumonia. Heart Lung. 1995;24:94–115. doi: 10.1016/S0147-9563(05)80004-4.
    1. Slutsky AS. Lung injury caused by mechanical ventilation. Chest. 1999;116:9S–15. doi: 10.1378/chest.116.suppl_1.9S-a.
    1. Tao T, Bo L, Chen F, Xie Q, Zou Y, Hu B, et al. Effect of protective ventilation on postoperative pulmonary complications in patients undergoing general anesthesia: a meta-analysis of randomised controlled trials. BMJ Open. 2014;4:e005208.
    1. Amato MB, Barbas CS, Medeiros DM, Magaldi RB, Schettino GP, Lorenzi-Filho G, et al. Effect of a protective-ventilation strategy on mortality in the acute respiratory distress syndrome. N Engl J Med. 1998;338:347–54. doi: 10.1056/NEJM199802053380602.
    1. Ferrando C, Ferrando C, Mugarra A, Gutierrez A, Carbonell JA, García M, et al. Setting individualized positive End-expiratory pressure level with a PEEP decrement trial after a recruitment maneuver improves oxygenation and lung mechanics during One-lung ventilation. Anesth Analg. 2014;118:657–65. doi: 10.1213/ANE.0000000000000105.
    1. Whalen FX, Gajic O, Thompson GB, Kendrick ML, Que FL, Williams BA, et al. The effects of the alveolar recruitment maneuver and positive end-expiratory pressure on arterial oxygenation during laparoscopic bariatric surgery. Anesth Analg. 2006;102:98–305. doi: 10.1213/01.ane.0000183655.57275.7a.
    1. Wolthuis EK, Vlaar AP, Choi G, Roelofs JJ, Juffermans NP, Schultz MJ. Mechanical ventilation using noninjurious ventilation settings causes lung injury in the absence of preexisting lung injury in healthy mice. Crit Care. 2009;13:R1. doi: 10.1186/cc7688.
    1. Imai Y, Parodo J, Kajikawa O, de Perrot M, Fischer S, Edwards V, et al. Injurious mechanical ventilation and end-organ epithelial cell apoptosis and organ dysfunction in an experimental model of acute respiratory distress syndrome. JAMA. 2003;289:2104–12. doi: 10.1001/jama.289.16.2104.
    1. Michelet P, D’Journo XB, Roch A, Doddoli C, Marin V, Papazian L, et al. Protective ventilation influences systemic inflammation after esophagectomy: a randomized controlled study. Anesthesiology. 2006;105:911–9. doi: 10.1097/00000542-200611000-00011.
    1. The Acute Respiratory Distress Syndrome Network Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med. 2000;342:1301–8. doi: 10.1056/NEJM200005043421801.
    1. Villar J, Kacmarek RM, Pérez-Méndez L, Aguirre-Jaime A. A high positive end- expiratory pressure, low tidal volume ventilatory strategy improves outcome in persistent acute respiratory distress syndrome: a randomized, controlled trial. Crit Care Med. 2006;34:1311–8. doi: 10.1097/01.CCM.0000215598.84885.01.
    1. Needham D, Colantuoni E, Mendez-Tellez PA, Dinglas VD, Sevransky JE, Dennison Himmelfarb CR, et al. Lung protective mechanical ventilation and two year survival in patients with acute lung injury: prospective cohort study. BMJ. 2012;344:2124–36. doi: 10.1136/bmj.e2124.
    1. Determann RM, Royakkers A, Wolthuis EK, Vlaar AP, Choi G, Paulus F, et al. Ventilation with lower tidal volumes as compared with conventional tidal volumes for patients without acute lung injury: a preventive randomized controlled trial. Crit Care. 2010;14:R1. doi: 10.1186/cc8230.
    1. Futier E, Constantin JM, Paugam-Burtz C, Pascal J, Eurin M, Neuschwander A, et al. A trial of intraoperative Low-tidal-volume ventilation in abdominal surgery. N Engl J Med. 2013;369:428–37. doi: 10.1056/NEJMoa1301082.
    1. Serpa Neto A, Cardoso SO, Manetta JA, Pereira VG, Espósito DC, Pasqualucci Mde O, et al. Association between use of lung- protective ventilation with lower tidal volumes and clinical outcomes among patients without acute respiratory distress syndrome: a meta-analysis. JAMA. 2012;308:1651–9. doi: 10.1001/jama.2012.13730.
    1. Hemmes SN, Serpa Neto A, Schultz MJ. Intraoperative ventilatory strategies to prevent postoperative pulmonary complications: a meta-analysis. Curr Opin Anesthesiol. 2013;26:126–33. doi: 10.1097/ACO.0b013e32835e1242.
    1. The PROVE. Network investigators High versus low positive end-expiratory pressure during general anesthesia for open abdominal surgery (PROVHILO trial): a multicenter randomised controlled trial. Lancet. 2014;384:495–503. doi: 10.1016/S0140-6736(14)60416-5.
    1. Lumb AB, Walton LJ. Perioperative oxygen toxicity. Anesthesiol Clin. 2012;30:591–605. doi: 10.1016/j.anclin.2012.07.009.
    1. Ferrando C, Soro M, Belda J. Protective strategies during cardiopulmanory bypass: ventilation, anesthestics and oxygen. Curr Opin Anaesthesiol. 2014. Epub ahead of print.
    1. García-de-la-Asunción J, Barber G, Rus D. Hyperoxia during colon surgery is associated with a reduction of xanthine oxidase activity and oxidative stress in colonic mucosa. Redox Rep. 2011;16:121–8. doi: 10.1179/174329211X13049558293632.
    1. Hovaguimian F, Lysakowski C, Elia N, Tramèr MR. Effect of intraoperative high inspired oxigen fraction on surgical site infection, postoperative nausea and vomiting, and pulmonary function: systematic review and meta-analysis of randomized trials. Anesthesiology. 2013;119:303–16. doi: 10.1097/ALN.0b013e31829aaff4.
    1. Belda FJ, Catalá-López F, Greif R, Canet J. Benefits and risks of intraoperative high inspired oxygen therapy: firm conclusions are still far off. Anesthesiology. 2014;120:1051–2. doi: 10.1097/ALN.0000000000000156.
    1. Canet J, Belda FJ. Perioperative hyperoxia: the debate is only getting started. Anesthesiology. 2011;114:1271–3. doi: 10.1097/ALN.0b013e31821bdbb5.
    1. Gattinoni L, Caironi P, Carlesso E. How to ventilate patients with acute lung injury and acute respiratory distress syndrome. Curr Opin Crit Care. 2005;11:69–76. doi: 10.1097/00075198-200502000-00011.
    1. Maish S, Reissmann H, Fuellekrug B, Weismann D, Rutkowski T, Tusman G, et al. Compliance and dead space fraction indicate an optimal level of positive End-expiratory pressure after recruitment in anesthetized patients. Anesth Analg. 2008;106:175–81. doi: 10.1213/01.ane.0000287684.74505.49.
    1. Glossop A, Shephard N, Bryden DC, Mills GH. Non-invasive ventilation for weaning, avoiding reintubation after extubation and in the postoperative period: a meta-analysis. Br J Anaesth. 2012;109:305–14. doi: 10.1093/bja/aes270.
    1. Ireland CJ, Chapman TM, Mathew SF, Herbison GP, Zacharias M. Continuous positive airway pressure (CPAP) during the postoperative period for prevention of postoperative morbidity and mortality following major abdominal surgery. Cochrane Database Syst Rev. 2014;8:CD008930.
    1. Canet J, Gallart L, Gomar C, Paluzie G, Vallès J, Castillo J, et al. Prediction of postoperative pulmonary complications in a population-based surgical cohort. Anesthesiology. 2010;113:1338–50. doi: 10.1097/ALN.0b013e3181fc6e0a.
    1. Tusman G, Belda FJ. Treatment of anesthesia-induced lung collapse with lung recruitment maneuvers. CACC. 2010;21:244–9.
    1. Ranieri VM, Rubenfeld GD, Thompson BT, Ferguson ND, Caldwell E, Fan E, et al. Acute respiratory distress syndrome: the Berlin Definition. JAMA. 2012;307:2526–33.
    1. Authors/Task Force Members, Dickstein K, Cohen-Solal A, Filippatos G, McMurray J, Ponikowski P, et al. ESC. Guidelines for the diagnosis and treatment of acute and chronic heart failure 2008: the task force for the diagnosis and treatment of acute and chronic heart failure 2008 of the european society of cardiology. Developed in collaboration with the heart failure association of the ESC (HFA) and endorsed by the european society of intensive care medicine (ESICM). Eur Heart J. 2008;29:2388–442.
    1. Mehta RL, Kellum JA, Shah SV, Molitoris BA, Ronco C, Warnock DG, et al. Acute kidney injury network: acute kidney injury network: report of an initiative to improve outcomes in acute kidney injury. Crit Care. 2007;11:R31. doi: 10.1186/cc5713.
    1. Horan TC, Gaynes RP, Martone WJ, Jarvis WR, Emori TG. CDC definitions of nosocomial surgical site infections, 1992: a modification of CDC definitions of surgical wound infections. Infect Control Hosp Epidemiol. 1992;13:606–8. doi: 10.2307/30148464.
    1. Chow S. Sample Size calculations in clinical research. Chapman & Hall/CRC Biostatistics Series; 2008
    1. Haybittle JL. Repeated assessment of results in clinical trials of cancer treatment. Br J Radiol. 1971;44:793–7. doi: 10.1259/0007-1285-44-526-793.
    1. Peto R, Pike MC, Armitage P, Breslow NE, Cox DR, Howard SV, et al. Design and analysis of randomized clinical trials requiring prolonged observation of each patient. I Introduction and design. Br J Cancer. 1976;34:585–612. doi: 10.1038/bjc.1976.220.
    1. Bendixen HH, Hedley-Whyte J, Laver MB. Impaired oxygenation in surgical patients during general anesthesia with controlled ventilation: a concept of atelectasis. N Engl J Med. 1963;269:991–6. doi: 10.1056/NEJM196311072691901.
    1. Magnusson L, Spahn DR. New concepts of atelectasis during general anaesthesia. Br J Anaesth. 2003;91:61e72. doi: 10.1093/bja/aeg085.
    1. Duggan M, Kavanagh BP. Pulmonary atelectasis: a pathogenic perioperative entity. Anesthesiology. 2005;102:838–54. doi: 10.1097/00000542-200504000-00021.
    1. Steinberg JM, Schiller HJ, Halter JM, Gatto LA, Lee HM, Pavone LA, et al. Alveolar instability causes early ventilator-induced lung injury independent of neutrophils. Am J Respir Crit Care Med. 2004;169:57e63.

Source: PubMed

Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

3
Abonnere