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1. Rationale and Study Design for an Individualized Perioperative Open Lung Ventilatory Strategy in Patients on One-Lung Ventilation (iPROVE-OLV).

Author

Carramiñana A, Ferrando C, Unzueta MC, Navarro R, Suárez-Sipmann F, Tusman G, Garutti I, Soro M, Pozo N, Librero J, Gallego L, Ramasco F, Rabanal JM, Rodriguez A, Sastre J, Martinez J, Coves S, García P, Aguirre-Puig P, Yepes J, Lluch A, López-Herrera D, Leal S, Vives M, Bellas S, Socorro T, Trespalacios R, Salazar CJ, Mugarra A, Cinnella G, Spadaro S, Futier E, Ferrer L, Cabrera M, Ribeiro H, Celestino C, Kucur E, Cervantes O, Morocho D, Delphy D, Ramos C, Villar J, and Belda J

Subjects
Humans, Postoperative Complications diagnosis, Postoperative Complications etiology, Postoperative Complications prevention & control, Prospective Studies, Single-Blind Method, Thoracic Surgery, Video-Assisted adverse effects, Internationality, One-Lung Ventilation methods, Perioperative Care methods, Positive-Pressure Respiration methods, Precision Medicine methods, Thoracic Surgery, Video-Assisted methods
Abstract

Objective: The aim of this clinical trial is to examine whether it is possible to reduce postoperative complications using an individualized perioperative ventilatory strategy versus using a standard lung-protective ventilation strategy in patients scheduled for thoracic surgery requiring one-lung ventilation., Design: International, multicenter, prospective, randomized controlled clinical trial., Setting: A network of university hospitals., Participants: The study comprises 1,380 patients scheduled for thoracic surgery., Interventions: The individualized group will receive intraoperative recruitment maneuvers followed by individualized positive end-expiratory pressure (open lung approach) during the intraoperative period plus postoperative ventilatory support with high-flow nasal cannula, whereas the control group will be managed with conventional lung-protective ventilation., Measurements and Main Results: Individual and total number of postoperative complications, including atelectasis, pneumothorax, pleural effusion, pneumonia, acute lung injury; unplanned readmission and reintubation; length of stay and death in the critical care unit and in the hospital will be analyzed for both groups. The authors hypothesize that the intraoperative application of an open lung approach followed by an individual indication of high-flow nasal cannula in the postoperative period will reduce pulmonary complications and length of hospital stay in high-risk surgical patients., (Copyright © 2019. Published by Elsevier Inc.)

Published
2019
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2. Open lung approach versus standard protective strategies: Effects on driving pressure and ventilatory efficiency during anesthesia - A pilot, randomized controlled trial.

Author

Ferrando C, Suarez-Sipmann F, Tusman G, León I, Romero E, Gracia E, Mugarra A, Arocas B, Pozo N, Soro M, and Belda FJ

Subjects
Aged, Capnography, Female, Humans, Male, Middle Aged, Tidal Volume, Anesthesiology methods, Lung physiology, Positive-Pressure Respiration
Abstract

Background: Low tidal volume (VT) during anesthesia minimizes lung injury but may be associated to a decrease in functional lung volume impairing lung mechanics and efficiency. Lung recruitment (RM) can restore lung volume but this may critically depend on the post-RM selected PEEP. This study was a randomized, two parallel arm, open study whose primary outcome was to compare the effects on driving pressure of adding a RM to low-VT ventilation, with or without an individualized post-RM PEEP in patients without known previous lung disease during anesthesia., Methods: Consecutive patients scheduled for major abdominal surgery were submitted to low-VT ventilation (6 ml·kg-1) and standard PEEP of 5 cmH2O (pre-RM, n = 36). After 30 min estabilization all patients received a RM and were randomly allocated to either continue with the same PEEP (RM-5 group, n = 18) or to an individualized open-lung PEEP (OL-PEEP) (Open Lung Approach, OLA group, n = 18) defined as the level resulting in maximal Cdyn during a decremental PEEP trial. We compared the effects on driving pressure and lung efficiency measured by volumetric capnography., Results: OL-PEEP was found at 8±2 cmH2O. 36 patients were included in the final analysis. When compared with pre-RM, OLA resulted in a 22% increase in compliance and a 28% decrease in driving pressure when compared to pre-RM. These parameters did not improve in the RM-5. The trend of the DP was significantly different between the OLA and RM-5 groups (p = 0.002). VDalv/VTalv was significantly lower in the OLA group after the RM (p = 0.035)., Conclusions: Lung recruitment applied during low-VT ventilation improves driving pressure and lung efficiency only when applied as an open-lung strategy with an individualized PEEP in patients without lung diseases undergoing major abdominal surgery., Trial Registration: ClinicalTrials.gov NCT02798133.

Published
2017
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3. Setting individualized positive end-expiratory pressure level with a positive end-expiratory pressure decrement trial after a recruitment maneuver improves oxygenation and lung mechanics during one-lung ventilation.

Author

Ferrando C, Mugarra A, Gutierrez A, Carbonell JA, García M, Soro M, Tusman G, and Belda FJ

Subjects
Aged, Female, Humans, Lung Compliance physiology, Male, Middle Aged, One-Lung Ventilation methods, Positive-Pressure Respiration methods, Respiratory Mechanics physiology
Abstract

Background: We investigated whether individualized positive end-expiratory pressure (PEEP) improves oxygenation, ventilation, and lung mechanics during one-lung ventilation compared with standardized PEEP., Methods: Thirty patients undergoing thoracic surgery were randomly allocated to the study or control group. Both groups received an alveolar recruitment maneuver at the beginning and end of one-lung ventilation. After the alveolar recruitment maneuver, the control group had their lungs ventilated with a 5 cm·H2O PEEP, while the study group had their lungs ventilated with an individualized PEEP level determined by a PEEP decrement trial. Arterial blood samples, lung mechanics, and volumetric capnography were recorded at multiple timepoints throughout the procedure., Results: The individualized PEEP values in study group were higher than the standardized PEEP values (10 ± 2 vs 5 cm·H2O; P < 0.001). In both groups, arterial oxygenation decreased when bilateral-lung ventilation was switched to one-lung ventilation and increased after the alveolar recruitment maneuver. During one-lung ventilation, oxygenation was maintained in the study group but decreased in the control group. After one-lung ventilation, arterial oxygenation was significantly higher in the study group (306 vs 231 mm·Hg, P = 0.007). Static compliance decreased in both groups when bilateral-lung ventilation was switched to one-lung ventilation. Static compliance increased significantly only in the study group (P < 0.001) after the alveolar recruitment maneuver and optimal PEEP adjustment. The alveolar recruitment maneuver did not decrease cardiac index in any patient., Conclusions: During one-lung ventilation, the improvements in oxygenation and lung mechanics after an alveolar recruitment maneuver were better preserved by ventilation by using individualized PEEP with a PEEP decrement trial than with a standardized 5 cm·H2O of PEEP.

Published
2014
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4. Intraoperative positive end-expiratory pressure and postoperative pulmonary complications: a patient-level meta-analysis of three randomised clinical trials

Author

Niklas S. Campos, Thomas Bluth, Sabrine N.T. Hemmes, Julian Librero, Natividad Pozo, Carlos Ferrando, Lorenzo Ball, Guido Mazzinari, Paolo Pelosi, Marcelo Gama de Abreu, Marcus J. Schultz, A. Serpa Neto, Sabrine NT. Hemmes, Paolo Severgnini, Markus W. Hollmann, Jan M. Binnekade, Hermann Wrigge, Jaume Canet, Michael Hiesmayr, Werner Schmid, Edda Tschernko, Samir Jaber, Göran Hedenstierna, Christian Putensen, Agnes Marti, Alessandro Bacuzzi, Alexander Brodhun, Alexandre Molin, Alfred Merten, Ana Parera, Andrea Brunelli, Andrea Cortegiani, Andreas Güldner, Andreas W. Reske, Angelo Gratarola, Antonino Giarratano, Bea Bastin, Bjorn Heyse, Branka Mazul-Sunko, Bruno Amantea, Bruno Barberis, Christopher Uhlig, Conrado Minguez Marín, Cristian Celentano, Daniela La Bella, David D’Antini, David Velghe, Demet Sulemanji, Edoardo De Robertis, Eric Hartmann, Francesca Montalto, Francesco Tropea, Gary H. Mills, Gilda Cinnella, Giorgio Della Rocca, Girolamo Caggianelli, Giulia Pellerano, Giuseppina Mollica, Guillermo Bugedo, Jan-Paul Mulier, Jeroen Vandenbrande, Johann Geib, Jonathan Yaqub, Jorge Florez, Juan F. Mayoral, Juraj Sprung, Jurgen Van Limmen, Lieuwe DJ. Bos, Luc de Baerdemaeker, Luc Jamaer, Luigi Spagnolo, Lydia Strys, Manuel Granell Gil, Marcos F. Vidal Melo, Maria Carmen Unzueta, Maria Victoria Moral, Marion Ferner, Martin Weiss, Massimo Vanoni, Maximilian S. Schaefer, Mercè Prieto, Michele Grio, Peter Markus Spieth, Philipp Simon, Phoebe Bodger, Pilar Sierra, Rita Laufenberg-Feldmann, Roberta Rusca, Rodolfo Proietti, Santi Maurizio Raineri, Santo Caroleo, Sergi Sabaté, Stefan De Hert, Stefano Pezzato, Tanja A. Treschan, Tatjana Goranovic, Thea Koch, Thomas Kiss, Valter Perilli, Virginia Cegarra, Javier Belda, Marina Soro, Carmen Unzueta, Fernando Suarez-Sipmann, Julián Librero, Alicia Llombart, Lucas Rovira, Manuel Granell, César Aldecoa, Oscar Diaz-Cambronero, Jaume Balust, Ignacio Garutti, Rafael Gonzalez, Lucia Gallego, Santiago Garcia del Valle, Javier Redondo, David Pestaña, Aurelio Rodríguez, Javier García, Manuel de la Matta, Maite Ibáñez, Francisco Barrios, Samuel Hernández, Vicente Torres, Salvador Peiró, Abigail Villena, Albert Carramiñana, Alberto Gallego-Casilda, Alejandro Duca, Amalia Alcón, Amanda Miñana, Ana Asensio, Ana Colás, Ana Isabel Galve, Ana Izquierdo, Ana Jurado, Ana María Pérez, Ana Mugarra, Andrea Gutierrez, Ángeles De Miguel, Angels Lozano, Antonio Katime, Antonio Romero, Beatriz Garrigues, Begoña Ayas, Blanca Arocas, Carlos Delgado, Carmen Fernández, Carolina Romero, Clara Gallego, Cristina Garcés, Cristina Lisbona, Cristina Parrilla, Daniel López-Herrera, Domingo González, Eduardo Llamazares, Elena Del Rio, Elena Lozano, Ernesto Pastor, Estefanía Chamorro, Estefanía Gracia, Ester Sánchez, Esther Romero, Fernando Díez, Ferran Serralta, Francisco Daviu, Francisco Sandín, Gerardo Aguilar, Gerardo Tusman, Gonzalo Azparren, Graciela Martínez-Pallí, Inmaculada Benítez, Inmaculada Hernandéz, Inmaculada India, Irene León, Isabel Fuentes, Isabel Ruiz, Jaume Puig, Javie Ignacio Román, Jesús Acosta, Jesús Rico-Feijoo, Jonathan Olmedo, Jose A. Carbonell, Jose M. Alonso, Jose María Pérez, Jose Miguel Marcos, Jose Navarro, Jose Valdivia, Juan Carrizo, Laura Piqueras, Laura Soriano, Laura Vaquero, Lisset Miguel, Lorena Muñoz, Lucia Valencia, Luis Olmedilla, Mᵃ Justina Etulain, Manuel Tisner, María Barrio, María Dolores Alonso, María García, María J. Hernández, María José Alberola, María Parra, María Pilar Argente, María Vila, Mario De Fez, Marta Agilaga, Marta Gine, Mercedes Ayuso, Mercedes García, Natalia Bejarano, Natalia Peña, Nazario Ojeda, Nilda Martínez, Nuria García, Oto Padrón, Pablo García, Paola Valls, Patricia Cruz, Patricia Piñeiro, Pedro Charco, Rafael Anaya, Ramiro López, Rayco Rodríguez, Rocío Martínez, Roger Pujol, Rosa Dosdá, Rosa Lardies, Ruben Díaz, Rubén Villazala, Sara Zapatero, Sergio Cabrera, Sergio Sánchez, Silvia Martin, Suzana Diaz, Tania Franco, Tania Moreno, Tania Socorro, Vicente Gilabert, Victor Balandrón, Victoria Moral, Virgina Cegarra, Viviana Varón, Fernando Abelha, Sühayla Abitağaoğlu, Marc Achilles, Afeez Adebesin, Ine Adriaensens, Charles Ahene, Fatima Akbar, Mohammed Al Harbi, Rita Al Khoury al Kallab, Xavier Albanel, Florence Aldenkortt, Rawan Abdullah Saleh Alfouzan, Reef Alruqaie, Fernando Altermatt, Bruno Luís de Castro Araujo, Genaro Arbesú, Hanna Artsi, Caterina Aurilio, Omer Hilmi Ayanoglu, Harris Baig, Yolanda Baird, Konstantin Balonov, Samantha Banks, Xiaodong Bao, Mélanie Baumgartner, Isabel Belda Tortosa, Alice Bergamaschi, Lars Bergmann, Luca Bigatello, Elena Biosca Pérez, Katja Birr, Elird Bojaxhi, Chiara Bonenti, Iwona Bonney, Elke M.E. Bos, Sara Bowman, Leandro Gobbo Braz, Elisa Brugnoni, Sorin J. Brull, Iole Brunetti, Andrea Bruni, Shonie L. Buenvenida, Cornelius Johannes Busch, Giovanni Camerini, Beatrice Capatti, Javiera Carmona, Jaime Carungcong, Marta Carvalho, Anat Cattan, Carla Cavaleiro, Davide Chiumello, Stefano Ciardo, Mark Coburn, Umberto Colella, Victor Contreras, Pelin Corman Dincer, Elizabeth Cotter, Marcia Crovetto, William Darrah, Simon Davies, Enrique Del Cojo Peces, Ellise Delphin, John Diaper, Paulo do Nascimento Junior, Valerio Donatiello, Jing Dong, Maria do Socorro Dourado, Alexander Dullenkopf, Felix Ebner, Hamed Elgendy, Christoph Ellenberger, Dilek Erdoğan Arı, Thomas Ermert, Fadi Farah, Ana Fernandez-Bustamante, Cristina Ferreira, Marco Fiore, Ana Fonte, Christina Fortià Palahí, Andrea Galimberti, Najia Garofano, Luca Gregorio Giaccari, Fernando Gilsanz, Felix Girrbach, Luca Gobbi, Marc Bernard Godfried, Nicolai Goettel, Peter A. Goldstein, Or Goren, Andrew Gorlin, Juan Graterol, Pierre Guyon, Kevin Haire, Philippe Harou, Antonia Helf, Gunther Hempel, María José Hernández Cádiz, Björn Heyse, Ivan Huercio, Jasmina Ilievska, Lien Jakus, Vijay Jeganath, Yvonne Jelting, Minoa Jung, Barbara Kabon, Aalok Kacha, Maja Karaman Ilić, Arunthevaraja Karuppiah, Ayse Duygu Kavas, Gleicy Keli Barcelos, Todd A. Kellogg, Johann Kemper, Romain Kerbrat, Suraya Khodr, Peter Kienbaum, Bunyamin Kir, Selin Kivrak, Vlasta Klarić, Ceren Köksal, Ana Kowark, Peter Kranke, Bahar Kuvaki, Biljana Kuzmanovska, John Laffey, Mirko Lange, Marília Freitas de Lemos, Marc-Joseph Licker, Manuel López-Baamonde, Antonio López-Hernández, Mercedes Lopez-Martinez, Stéphane Luise, Mark MacGregor, Danielle Magalhães, Julien Maillard, Patrizia Malerbi, Natesan Manimekalai, Michael Margarson, Klaus Markstaller, Archer K. Martin, David P. Martin, Yvette N. Martin, Julia Martínez-Ocon, Ignacio Martin-Loeches, Emilio Maseda, Idit Matot, Niamh McAuliffe, Travis J. McKenzie, Paulina Medina, Melanie Meersch, Angelika Menzen, Els Mertens, Bernd Meurer, Tanja Meyer-Treschan, Changhong Miao, Camilla Micalizzi, Morena Milić, Norma Sueli Pinheiro Módolo, Pierre Moine, Patrick Mölders, Ana Montero-Feijoo, Enrique Moret, Markus K. Muller, Zoe Murphy, Pramod Nalwaya, Filip Naumovski, Paolo Navalesi, Lais Helena Navarro e Lima, Višnja Nesek Adam, Claudia Neumann, Christopher Newell, Zoulfira Nisnevitch, Junaid Nizamuddin, Cecilia Novazzi, Michael O'Connor, Günther Oprea, Mukadder Orhan Sungur, Şule Özbilgin, Maria Caterina Pace, Marcos Pacheco, Balaji Packianathaswamy, Estefania Palma Gonzalez, Fotios Papaspyros, Sebastián Paredes, Maria Beatrice Passavanti, Juan Cristobal Pedemonte, Sanja Peremin, Christoph Philipsenburg, Daniela Pinho, Silvia Pinho, Linda M. Posthuma, Vincenzo Pota, Benedikt Preckel, Paolo Priani, Mohamed Aymen Rached, Aleksandar Radoeshki, Riccardo Ragazzi, Tamilselvan Rajamanickam, Arthi Rajamohan, Harish Ramakrishna, Desikan Rangarajan, Christian Reiterer, J. Ross Renew, Thomas Reynaud, Rhidian Rhys, Eva Rivas, Luisa Robitzky, Rolf Rossaint, Francesca Rubulotta, Humberto S. Machado, Catarina S. Nunes, Giovanni Sabbatini, Jon D. Samuels, Josep Martí Sanahuja, Pasquale Sansone, Alice Santos, Mohamed Sayedalahl, Martin Scharffenberg, Eduardo Schiffer, Nadja Schliewe, Raoul Schorer, Roman Schumann, Gabriele Selmo, Mar Sendra, Mert Senturk, Kate Shaw, Mirjana Shosholcheva, Abdulrazak Sibai, Francesca Simonassi, Claudia Sinno, Nukhet Sivrikoz, Vasiliki Skandalou, Neil Smith, Maria Soares, Tania Socorro Artiles, Diogo Sousa Castro, Miguel Sousa, Savino Spadaro, Emmanouil Stamatakis, Luzius A. Steiner, Andrea Stevenazzi, Alejandro Suarez-de-la-Rica, Mélanie Suppan, Robert Teichmann, José Maria Tena Guerrero, Bram Thiel, Raquel Tolós, Gulbin Tore Altun, Michelle Tucci, Zachary A. Turnbull, Žana Turudić, Matthias Unterberg, Yves Van Nieuwenhove, Julia Van Waesberghe, Marcos Francisco Vidal Melo, Bibiana Vitković, Luigi Vivona, Marcela Vizcaychipi, Carlo Alberto Volta, Anne Weber, Toby N. Weingarten, Jakob Wittenstein, Piet Wyffels, Julio Yagüe, David Yates, Ayşen Yavru, Lilach Zac, Jing Zhong, Anesthesiology, Intensive Care Medicine, ACS - Pulmonary hypertension & thrombosis, ACS - Diabetes & metabolism, ACS - Microcirculation, Campos, Niklas S, Bluth, Thoma, Hemmes, Sabrine N T, Librero, Julian, Pozo, Natividad, Ferrando, Carlo, Ball, Lorenzo, Mazzinari, Guido, Pelosi, Paolo, Gama de Abreu, Marcelo, Schultz, Marcus J, Serpa Neto, A, investigators for the PROVHILO study including, Cortegiani, Andrea, Raineri, Santi Maurizio, and Giarratano, Antonino

Subjects
Adult, Lung Diseases, PEEP, postoperative pulmonary complications, mechanical ventilation, Positive-Pressure Respiration, surgery, Anesthesiology and Pain Medicine, Postoperative Complications, Tidal Volume, Humans, Postoperative Period, Lung, Randomized Controlled Trials as Topic
Abstract

BACKGROUND: High intraoperative PEEP with recruitment manoeuvres may improve perioperative outcomes. We re-examined this question by conducting a patient-level meta-analysis of three clinical trials in adult patients at increased risk for postoperative pulmonary complications who underwent non-cardiothoracic and non-neurological surgery. METHODS: The three trials enrolled patients at 128 hospitals in 24 countries from February 2011 to February 2018. All patients received volume-controlled ventilation with low tidal volume. Analyses were performed using one-stage, two-level, mixed modelling (site as a random effect; trial as a fixed effect). The primary outcome was a composite of postoperative pulmonary complications within the first week, analysed using mixed-effect logistic regression. Pre-specified subgroup analyses of nine patient characteristics and seven procedure and care-delivery characteristics were also performed. RESULTS: Complete datasets were available for 1913 participants ventilated with high PEEP and recruitment manoeuvres, compared with 1924 participants who received low PEEP. The primary outcome occurred in 562/1913 (29.4%) participants randomised to high PEEP, compared with 620/1924 (32.2%) participants randomised to low PEEP (unadjusted odds ratio [OR]=0.87; 95% confidence interval [95% CI], 0.75-1.01; P=0.06). Higher PEEP resulted in 87/1913 (4.5%) participants requiring interventions for desaturation, compared with 216/1924 (11.2%) participants randomised to low PEEP (OR=0.34; 95% CI, 0.26-0.45). Intraoperative hypotension was associated more frequently (784/1913 [41.0%]) with high PEEP, compared with low PEEP (579/1924 [30.1%]; OR=1.87; 95% CI, 1.60-2.17). CONCLUSIONS: High PEEP combined with recruitment manoeuvres during low tidal volume ventilation in patients undergoing major surgery did not reduce postoperative pulmonary complications. CLINICAL TRIAL REGISTRATION: NCT03937375 (Clinicaltrials.gov).

Published
2022

5. Effects of oxygen on post-surgical infections during an individualised perioperative open-lung ventilatory strategy: a randomised controlled trial

Author

Daniel López-Herrera, Raluca Florea, Rosa Almajano, Inmaculada India, Gerardo Aguilar, Javier Hernández, Juan Carrizo, Antonio López, Rafael Cabadas, Manuel Ortega, Elena Del Río, Elizabeth Bárcena, Cristina Garcés, Maite Ibáñez, María José Alberola, Amalia Alcón, Rayco Rodríguez, Jesús Castillo, Rafael Anaya, Ferran Serralta, Victor Balandrón, Cristian Aragón, Santiago Pinol, M. Granell, Domingo González, Inés Imaz, Yessica Guerra, Laura Reviriego, Alejandro Duca, Rubén Villazala, Jara Torrente, Lola Ruiz, Jesús Acosta, Marina Soro, Lucas Rovira, Natalia Bejarano, Jaume Balust, Paula Duque, Jaume Puig, Carmen Fernández, Raquel Callejas, Vanesa Berges, Omar M. Montenegro, Lucia Gallego-Ligorit, Pablo Monedero, Juan Delgado, Graciela Martínez, Santiago Garcia Del Valle, Sergio Cabrera, Carlos Álvarez, Lorena Colomina, Ana Martín, Ernesto Pastor, Sara Visiedo, Laura Sancho, Isabel Fuentes, Rafael González, Alejandro Gracia, Enrique Alday, Beatriz García, Ana Colás, Paola Valls, Maria Guillén Bermejo, Ana Parera, Estefania Gracia, Carlos Ferrando, Gemma Echarri, Carlos Dexeus, Miriam Herrero, Gerardo Tusman, Irene León, Ana Perez, Sergio Sánchez, Patricia Cruz, Sonsoles Leal, Javier Cuervo, Pascual Martinez, Carlos R. Molina, Andrea Brunelli, Salomé Matoses, Francisco Sandín, Clara Gallego, Luis Belmonte, Aurelio Rodríguez, Sara Pérez, Fernando Gil, Marina Varela, Esperanza Mata, Blanca Romero, Francisco J Redondo, Eva Tres, Ana Jurado, Maria Garcia, Manuel de la Matta, Pablo Oliver-Forniés, Esther García, Julia Hernando, Natividad Quesada, Jose L. Muñoz, Marta Argilaga, María A. Palencia, Angels Lozano, Laura Lascorz, Blanca Arocas, Mercedes García, Laura Viguera, Benigno Rodríguez, Consuelo Rego, Abigail Villena, Rodrigo Molina, Pilar Forcada, Carmen Unzueta, Esther Romero, Viviana Varón, F. Javier Belda, Patricia Fabra, Gema Del Castillo, Julián Librero, Pedro Charco, Gonzalo Azparren, María Merino, Sara Martínez, Mar Felipe, Ana Ramón, Salvador Peiró, Ruben Díaz, Maria del Mar Pérez, Mandalina Dinu, Roger Pujol, José M. Marcos, Beatriz Garrigues, Laura Cotter, Begoña Ayas, Oscar Diaz-Cambronero, Andrea Gutierrez, Rosa Mendez, Natividad Pozo, Jose Ignacio García, Ana Mugarra, José A. Carbonell, Manuel López-Baamonde, Lucía Valencia, Guido Mazzirani, Blanca Izquierdo, Marta Roselló, Andrés Millaruelo, Berta Monleon, Cesar Aldecoa, Ignacio Garutti, Victor Vega, Noelia Lafuente, Jesús Villar, David Pestaña, Laura Vaquero, and Fernando Suarez-Sipmann

Subjects
Adult, Male, Pulmonary Atelectasis, recruitment manoeuvres, Context (language use), Atelectasis, Perioperative Care, law.invention, Positive-Pressure Respiration, sepsis, surgery, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, 030202 anesthesiology, law, Fraction of inspired oxygen, Intensive care, Abdomen, postoperative complications, medicine, Humans, Surgical Wound Infection, Precision Medicine, Aged, Aged, 80 and over, business.industry, inspiratory oxygen fraction, anaesthesia, Perioperative, Middle Aged, surgical site infection, medicine.disease, Respiration, Artificial, Oxygen, Clinical trial, Treatment Outcome, Anesthesiology and Pain Medicine, Oxyhemoglobins, Anesthesia, Female, business, positive end-expiratory pressure, Abdominal surgery
Abstract

Background We aimed to examine whether using a high fraction of inspired oxygen (FIO2) in the context of an individualised intra- and postoperative open-lung ventilation approach could decrease surgical site infection (SSI) in patients scheduled for abdominal surgery. Methods We performed a multicentre, randomised controlled clinical trial in a network of 21 university hospitals from June 6, 2017 to July 19, 2018. Patients undergoing abdominal surgery were randomly assigned to receive a high (0.80) or conventional (0.3) FIO2 during the intraoperative period and during the first 3 postoperative hours. All patients were mechanically ventilated with an open-lung strategy, which included recruitment manoeuvres and individualised positive end-expiratory pressure for the best respiratory-system compliance, and individualised continuous postoperative airway pressure for adequate peripheral oxyhaemoglobin saturation. The primary outcome was the prevalence of SSI within the first 7 postoperative days. The secondary outcomes were composites of systemic complications, length of intensive care and hospital stay, and 6-month mortality. Results We enrolled 740 subjects: 371 in the high FIO2 group and 369 in the low FIO2 group. Data from 717 subjects were available for final analysis. The rate of SSI during the first postoperative week did not differ between high (8.9%) and low (9.4%) FIO2 groups (relative risk [RR]: 0.94; 95% confidence interval [CI]: 0.59–1.50; P=0.90]). Secondary outcomes, such as atelectasis (7.7% vs 9.8%; RR: 0.77; 95% CI: 0.48–1.25; P=0.38) and myocardial ischaemia (0.6% [n=2] vs 0% [n=0]; P=0.47) did not differ between groups. Conclusions An oxygenation strategy using high FIO2 compared with conventional FIO2 did not reduce postoperative SSIs in abdominal surgery. No differences in secondary outcomes or adverse events were found. Clinical trial registration NCT02776046.

Published
2020
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6. Individualised perioperative open-lung approach versus standard protective ventilation in abdominal surgery (iPROVE): a randomised controlled trial

Author

Rubén Villazala, Victoria Moral, Nazario Ojeda, Andrea Gutierrez, Tania Socorro, Inmaculada India, Angels Lozano, Ana Mugarra, Natividad Pozo, Jose Ignacio García, María Dolores Alonso, Ernesto Pastor, Amanda Miñana, Ana Isabel Galve, Elena Lozano, Eduardo Llamazares, Gonzalo Azparren, Ana Parera, Lucas Rovira, Rafael González, Luis Olmedilla, José I. Navarro, Javier Contreras García, Carolina Romero, Abigail Villena, Julián Librero, David Pestaña, Mercedes García, Cristina Parrilla, Isabel Fuentes, Carmen Fernández, Pedro Charco, Lucía Gallego, Jesús Acosta, Maria Del Barrio, Cristina Garcés, Maite Ibáñez, Nuria Garcia, Salvador Peiró, Javier Ignacio Román, Elena Del Río, Sergio Sánchez, Lorena Muñoz, Amalia Alcón, Carmen Unzueta, Roger Pujol, Cesar Aldecoa, Maria Garcia, Lucía Valencia, Estefanía Chamorro, Clara Gallego, Jesús Rico-Feijoo, María Pilar Argente, Laura Soriano, Fernando Díez, Inmaculada Benítez, Andrea Brunelli, Natalia Peña, Vicente Torres, María Asunción Parra, Alicia Llombart, Samuel Hernández, Gerardo Aguilar, Patricia Piñeiro, Albert Carramiñana, Ferran Serralta, Ignacio Garutti, Jose M. Alonso, Beatriz Garrigues, Gerardo Tusman, Irene León, Marta Giné, Patricia Cruz, Antonio Katime, Ana Asensio, Esther Romero, Francisco Daviu, Susana Díaz, Jonathan Olmedo, Viviana Varón, Sara Zapatero, María José Alberola, Francisco J Redondo, Cristina Lisbona, Isabel Ruiz, Tania Moreno, Pablo Garcia, Ana Izquierdo, Jesús Villar, Alberto Gallego-Casilda, Blanca Arocas, Begoña Ayas, Jaume Puig, José A. Carbonell, Oto Padrón, Marina Soro, Ester Sánchez, Natalia Bejarano, Oscar Diaz-Cambronero, Ruben Díaz, María Vila, Ana María Pérez, Francisco Sandín, Ramiro López, Estefania Gracia, Manuel Tisner, Virginia Cegarra, María Hernández, Jaume Canet, Graciella Martínez-Pallí, José M. Marcos, Angeles de Miguel, Jaume Balust, Laura Vaquero, Sergio Cabrera, Fernando Suarez-Sipmann, Daniel López-Herrera, Juan Carrizo, Mercedes Ayuso, Nilda Martínez, Silvia Martín, Rayco Rodríguez, Rafael Anaya, Jose María Pérez, Rosa Lardies, M. Granell, Domingo González, Inmaculada Hernández, Rosa Dosdá, Carlos Ferrando, Carlos Delgado, Mario De Fez, Santiago García-del-Valle, Ana Jurado, Guido Mazzinari, Paola Valls, Marta Agilaga, Antonio Romero, Victor Balandrón, Alejandro Duca, Rocío Martínez, Francisco Barrios, Ma Justina Etulain, Tania Franco, Vicente Gilabert, Laura Piqueras, Aurelio Rodríguez, Javier Belda, Lisset Miguel, José Valdivia, Ana Colás, and Manuel de la Matta

Subjects
Male, Pulmonary and Respiratory Medicine, medicine.medical_treatment, Population, Perioperative Care, law.invention, Positive-Pressure Respiration, 03 medical and health sciences, Postoperative Complications, 0302 clinical medicine, Randomized controlled trial, 030202 anesthesiology, law, Oxygen therapy, Abdomen, medicine, Humans, Prospective Studies, 030212 general & internal medicine, Continuous positive airway pressure, education, Lung, Aged, Mechanical ventilation, education.field_of_study, business.industry, Perioperative, Middle Aged, Respiration, Artificial, respiratory tract diseases, Treatment Outcome, Spain, Anesthesia, Breathing, Female, business, Abdominal surgery
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.

Published
2018

7. Open lung approach versus standard protective strategies: Effects on driving pressure and ventilatory efficiency during anesthesia - A pilot, randomized controlled trial

Author

Natividad Pozo, Estefania Gracia, Francisco Javier Belda, Carlos Ferrando, Gerardo Tusman, Irene León, Marina Soro, Blanca Arocas, Esther Romero, Fernando Suarez-Sipmann, and Ana Mugarra

Subjects
Male, Medicin och hälsovetenskap, Pulmonology, Respiratory System, lcsh:Medicine, Pulmonary Function, Hemodynamics, Medical and Health Sciences, law.invention, Positive-Pressure Respiration, 0302 clinical medicine, Randomized controlled trial, Anesthesiology, 030202 anesthesiology, law, Medicine and Health Sciences, Pressure Anesthesia, Medicine, Anesthesia, Lung volumes, 030212 general & internal medicine, lcsh:Science, Lung, Tidal volume, Capnography, Multidisciplinary, medicine.diagnostic_test, Pharmaceutics, Middle Aged, respiratory system, medicine.anatomical_structure, Abdominal Surgery, Female, Anatomy, circulatory and respiratory physiology, Research Article, Surgical and Invasive Medical Procedures, Respiratory physiology, Lung injury, 03 medical and health sciences, Drug Therapy, Tidal Volume, Humans, Aged, business.industry, lcsh:R, Biology and Life Sciences, respiratory tract diseases, lcsh:Q, Local and Regional Anesthesia, Lungs, business
Abstract

BACKGROUND:Low tidal volume (VT) during anesthesia minimizes lung injury but may be associated to a decrease in functional lung volume impairing lung mechanics and efficiency. Lung recruitment (RM) can restore lung volume but this may critically depend on the post-RM selected PEEP. This study was a randomized, two parallel arm, open study whose primary outcome was to compare the effects on driving pressure of adding a RM to low-VT ventilation, with or without an individualized post-RM PEEP in patients without known previous lung disease during anesthesia. METHODS:Consecutive patients scheduled for major abdominal surgery were submitted to low-VT ventilation (6 ml·kg-1) and standard PEEP of 5 cmH2O (pre-RM, n = 36). After 30 min estabilization all patients received a RM and were randomly allocated to either continue with the same PEEP (RM-5 group, n = 18) or to an individualized open-lung PEEP (OL-PEEP) (Open Lung Approach, OLA group, n = 18) defined as the level resulting in maximal Cdyn during a decremental PEEP trial. We compared the effects on driving pressure and lung efficiency measured by volumetric capnography. RESULTS:OL-PEEP was found at 8±2 cmH2O. 36 patients were included in the final analysis. When compared with pre-RM, OLA resulted in a 22% increase in compliance and a 28% decrease in driving pressure when compared to pre-RM. These parameters did not improve in the RM-5. The trend of the DP was significantly different between the OLA and RM-5 groups (p = 0.002). VDalv/VTalv was significantly lower in the OLA group after the RM (p = 0.035). CONCLUSIONS:Lung recruitment applied during low-VT ventilation improves driving pressure and lung efficiency only when applied as an open-lung strategy with an individualized PEEP in patients without lung diseases undergoing major abdominal surgery. TRIAL REGISTRATION:ClinicalTrials.gov NCT02798133.

Published
2017
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8. Setting individualized positive end-expiratory pressure level with a positive end-expiratory pressure decrement trial after a recruitment maneuver improves oxygenation and lung mechanics during one-lung ventilation

Author

Andrea Gutierrez, Ana Mugarra, Francisco Javier Belda, Gerardo Tusman, Marina Soro, José A. Carbonell, Carlos Ferrando, and Marisa García

Subjects
Male, medicine.medical_specialty, law.invention, Positive-Pressure Respiration, Randomized controlled trial, Recruitment maneuver, law, medicine, Humans, Lung Compliance, Positive end-expiratory pressure, Aged, business.industry, Lung mechanics, Oxygenation, respiratory system, Middle Aged, One lung ventilation, respiratory tract diseases, One-Lung Ventilation, Anesthesiology and Pain Medicine, Cardiothoracic surgery, Anesthesia, Breathing, Respiratory Mechanics, Female, business, therapeutics, circulatory and respiratory physiology
Abstract

We investigated whether individualized positive end-expiratory pressure (PEEP) improves oxygenation, ventilation, and lung mechanics during one-lung ventilation compared with standardized PEEP.Thirty patients undergoing thoracic surgery were randomly allocated to the study or control group. Both groups received an alveolar recruitment maneuver at the beginning and end of one-lung ventilation. After the alveolar recruitment maneuver, the control group had their lungs ventilated with a 5 cm·H2O PEEP, while the study group had their lungs ventilated with an individualized PEEP level determined by a PEEP decrement trial. Arterial blood samples, lung mechanics, and volumetric capnography were recorded at multiple timepoints throughout the procedure.The individualized PEEP values in study group were higher than the standardized PEEP values (10 ± 2 vs 5 cm·H2O; P0.001). In both groups, arterial oxygenation decreased when bilateral-lung ventilation was switched to one-lung ventilation and increased after the alveolar recruitment maneuver. During one-lung ventilation, oxygenation was maintained in the study group but decreased in the control group. After one-lung ventilation, arterial oxygenation was significantly higher in the study group (306 vs 231 mm·Hg, P = 0.007). Static compliance decreased in both groups when bilateral-lung ventilation was switched to one-lung ventilation. Static compliance increased significantly only in the study group (P0.001) after the alveolar recruitment maneuver and optimal PEEP adjustment. The alveolar recruitment maneuver did not decrease cardiac index in any patient.During one-lung ventilation, the improvements in oxygenation and lung mechanics after an alveolar recruitment maneuver were better preserved by ventilation by using individualized PEEP with a PEEP decrement trial than with a standardized 5 cm·H2O of PEEP.

Published
2014

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