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  1. Article ; Online: Individualised, perioperative open-lung ventilation strategy during one-lung ventilation (iPROVE-OLV): a multicentre, randomised, controlled clinical trial.

    Ferrando, Carlos / Carramiñana, Albert / Piñeiro, Patricia / Mirabella, Lucia / Spadaro, Savino / Librero, Julián / Ramasco, Fernando / Scaramuzzo, Gaetano / Cervantes, Oriol / Garutti, Ignacio / Parera, Ana / Argilaga, Marta / Herranz, Gracia / Unzueta, Carmen / Vives, Marc / Regi, Kevin / Costa-Reverte, Marta / Sonsoles Leal, María / Nieves-Alonso, Jesús /
    García, Esther / Rodríguez-Pérez, Aurelio / Fariña, Roberto / Cabrera, Sergio / Guerra, Elisabeth / Gallego-Ligorit, Lucia / Herrero-Izquierdo, Alba / Vallés-Torres, J / Ramos, Silvia / López-Herrera, Daniel / De La Matta, Manuel / Gokhan, Sertcakacilar / Kucur, Evrim / Mugarra, Ana / Soro, Marina / García, Laura / Sastre, José Alfonso / Aguirre, Pilar / Salazar, Claudia Jimena / Ramos, María Carolina / Morocho, Diego Rolando / Trespalacios, Ramón / Ezequiel-Fernández, Félix / Lamanna, Angella / Pia Cantatore, Leonarda / Laforgia, Donato / Bellas, Soledad / López, Carlos / Navarro-Ripoll, Ricard / Martínez, Samira / Vallverdú, Jordi / Jacas, Adriana / Yepes-Temiño, María José / Belda, Francisco Javier / Tusman, Gerardo / Suárez-Sipmann, Fernando / Villar, Jesús

    The Lancet. Respiratory medicine

    2023  Volume 12, Issue 3, Page(s) 195–206

    Abstract: Background: It is uncertain whether individualisation of the perioperative open-lung approach (OLA) to ventilation reduces postoperative pulmonary complications in patients undergoing lung resection. We compared a perioperative individualised OLA (iOLA) ...

    Abstract Background: It is uncertain whether individualisation of the perioperative open-lung approach (OLA) to ventilation reduces postoperative pulmonary complications in patients undergoing lung resection. We compared a perioperative individualised OLA (iOLA) ventilation strategy with standard lung-protective ventilation in patients undergoing thoracic surgery with one-lung ventilation.
    Methods: This multicentre, randomised controlled trial enrolled patients scheduled for open or video-assisted thoracic surgery using one-lung ventilation in 25 participating hospitals in Spain, Italy, Turkey, Egypt, and Ecuador. Eligible adult patients (age ≥18 years) were randomly assigned to receive iOLA or standard lung-protective ventilation. Eligible patients (stratified by centre) were randomly assigned online by local principal investigators, with an allocation ratio of 1:1. Treatment with iOLA included an alveolar recruitment manoeuvre to 40 cm H
    Findings: Between Sept 11, 2018, and June 14, 2022, we enrolled 1380 patients, of whom 1308 eligible patients (670 [434 male, 233 female, and three with missing data] assigned to iOLA and 638 [395 male, 237 female, and six with missing data] to standard lung-protective ventilation) were included in the final analysis. The proportion of patients with the composite outcome of severe postoperative pulmonary complications within the first 7 postoperative days was lower in the iOLA group compared with the standard lung-protective ventilation group (40 [6%] vs 97 [15%], relative risk 0·39 [95% CI 0·28 to 0·56]), with an absolute risk difference of -9·23 (95% CI -12·55 to -5·92). Recruitment manoeuvre-related adverse events were reported in five patients.
    Interpretation: Among patients subjected to lung resection under one-lung ventilation, iOLA was associated with a reduced risk of severe postoperative pulmonary complications when compared with conventional lung-protective ventilation.
    Funding: Instituto de Salud Carlos III and the European Regional Development Funds.
    MeSH term(s) Adult ; Humans ; Female ; Male ; Adolescent ; One-Lung Ventilation ; Respiration ; Continuous Positive Airway Pressure ; Lung/surgery ; Oxygen
    Chemical Substances Oxygen (S88TT14065)
    Language English
    Publishing date 2023-12-05
    Publishing country England
    Document type Randomized Controlled Trial ; Multicenter Study ; Journal Article
    ZDB-ID 2686754-0
    ISSN 2213-2619 ; 2213-2600
    ISSN (online) 2213-2619
    ISSN 2213-2600
    DOI 10.1016/S2213-2600(23)00346-6
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Rationale and Study Design for an Individualized Perioperative Open Lung Ventilatory Strategy in Patients on One-Lung Ventilation (iPROVE-OLV).

    Carramiñana, Albert / Ferrando, Carlos / Unzueta, M Carmen / Navarro, Ricard / Suárez-Sipmann, Fernando / Tusman, Gerardo / Garutti, Ignacio / Soro, Marina / Pozo, Natividad / Librero, Julián / Gallego, Lucía / Ramasco, Fernando / Rabanal, José M / Rodriguez, Aurelio / Sastre, José / Martinez, Jesús / Coves, Silvia / García, Pablo / Aguirre-Puig, Pilar /
    Yepes, José / Lluch, Aitana / López-Herrera, Daniel / Leal, Sonsoles / Vives, Marc / Bellas, Soledad / Socorro, Tania / Trespalacios, Ramón / Salazar, Claudia J / Mugarra, Ana / Cinnella, Gilda / Spadaro, Savino / Futier, Emmanuel / Ferrer, Leopoldo / Cabrera, María / Ribeiro, Helder / Celestino, Catarina / Kucur, Evrim / Cervantes, Oriol / Morocho, Diego / Delphy, Dalia / Ramos, Carolina / Villar, Jesús / Belda, Javier

    Journal of cardiothoracic and vascular anesthesia

    2019  Volume 33, Issue 9, Page(s) 2492–2502

    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 ... ...

    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.
    MeSH term(s) Humans ; Internationality ; One-Lung Ventilation/methods ; Perioperative Care/methods ; Positive-Pressure Respiration/methods ; Postoperative Complications/diagnosis ; Postoperative Complications/etiology ; Postoperative Complications/prevention & control ; Precision Medicine/methods ; Prospective Studies ; Single-Blind Method ; Thoracic Surgery, Video-Assisted/adverse effects ; Thoracic Surgery, Video-Assisted/methods
    Language English
    Publishing date 2019-02-08
    Publishing country United States
    Document type Journal Article ; Multicenter Study ; Randomized Controlled Trial
    ZDB-ID 1067317-9
    ISSN 1532-8422 ; 1053-0770
    ISSN (online) 1532-8422
    ISSN 1053-0770
    DOI 10.1053/j.jvca.2019.01.056
    Database MEDical Literature Analysis and Retrieval System OnLINE

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