François Lellouche, Emmanuel Futier, Maellen Gouillou, Erwan L'Her, Daniel Verzilli, Emmanuel Nowak, Christophe Jacob, Pierre-Alexandre Bouchard, Samir Jaber, Brigitte Huiban, Thomas Kerforne, Victoire Pateau, Service de Réanimation Médicale (BREST - Réa Med), Centre Hospitalier Régional Universitaire de Brest (CHRU Brest), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Physiologie & médecine expérimentale du Cœur et des Muscles [U 1046] (PhyMedExp), Centre National de la Recherche Scientifique (CNRS)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM), Interactions Arbres-Microorganismes (IAM), Université de Lorraine (UL)-Institut National de la Recherche Agronomique (INRA), Département anesthésie et réanimation, CHU Clermont-Ferrand-Hôpital d'Estaing, Département d'Anesthésie et Réanimation Chirurgicale [Poitiers], Centre hospitalier universitaire de Poitiers (CHU Poitiers), Centre d'Investigation Clinique (CIC - Brest), Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie, Université Laval, MORNET, Dominique, Laboratoire de Traitement de l'Information Medicale (LaTIM), Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre Hospitalier Régional Universitaire de Brest (CHRU Brest)-IMT Atlantique (IMT Atlantique), Institut Mines-Télécom [Paris] (IMT)-Institut Mines-Télécom [Paris] (IMT)-Institut Brestois Santé Agro Matière (IBSAM), Université de Brest (UBO), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS), Service d'Anésthésie Réanimation [CHU Clermont-Ferrand], CHU Estaing [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand, Université Laval [Québec] (ULaval), Institut National de la Santé et de la Recherche Médicale (INSERM)-IMT Atlantique Bretagne-Pays de la Loire (IMT Atlantique), Institut Mines-Télécom [Paris] (IMT)-Institut Mines-Télécom [Paris] (IMT)-Centre Hospitalier Régional Universitaire de Brest (CHRU Brest)-Université de Brest (UBO)-Institut Brestois Santé Agro Matière (IBSAM), and Université de Montpellier (UM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)
IntroductionHypoxemia and hyperoxia may occur after surgery with potential related complications. The FreeO2PostOp trial is a prospective, multicentre, randomised controlled trial that evaluates the clinical impact of automated O2administration versus conventional O2therapy after major abdominal or thoracic surgeries. The study is powered to demonstrate benefits of automated oxygen titration and weaning in term of oxygenation, which is an important surrogate for complications after such interventions.Methods and analysisAfter extubation, patients are randomly assigned to theStandard(manual O2administration) orFreeO2group (automated closed-loop O2administration). Stratification is performed for the study centre and a medical history of chronic obstructive pulmonary disease (COPD). Primary outcome is the percentage of time spent in the target zone of oxygen saturation, during a 3-day time frame. In both groups, patients will benefit from continuous oximetry recordings. The target zone of oxygen saturation is SpO2=88%–92% for patients with COPD and 92%–96% for patients without COPD. Secondary outcomes are the nursing workload assessed by the number of manual O2flow adjustments, the time spent with severe desaturation (SpO22>98%), the time spent in a hyperoxia area (SpO2>98%), the VO2, the duration of oxygen administration during hospitalisation, the frequency of use of mechanical ventilation (invasive or non-invasive), the duration of the postrecovery room stay, the hospitalisation length of stay and the survival rate.Ethics and disseminationThe FreeO2PostOp study is conducted in accordance with the declaration of Helsinki and was registered on 11 September 2015 (http://www.clinicaltrials.gov). First patient inclusion was performed on 14 January 2016. The results of the study will be presented at academic conferences and submitted to peer-reviewed journals.Trial registration numberNCT02546830.