Lorenzo Gamberini1, Tommaso Tonetti2, Savino Spadaro3, Gianluca Zani4, Carlo Alberto Mazzoli1, Chiara Capozzi5, Emanuela Giampalma6, Maria Letizia Bacchi Reggiani7, Elisabetta Bertellini8, Andrea Castelli5, Irene Cavalli9, Davide Colombo10,11, Federico Crimaldi12, Federica Damiani13, Alberto Fogagnolo3, Maurizio Fusari4, Emiliano Gamberini14, Giovanni Gordini1, Cristiana Laici15, Maria Concetta Lanza16, Mirco Leo17, Andrea Marudi8, Giuseppe Nardi18, Irene Ottaviani3, Raffaella Papa19, Antonella Potalivo18, Emanuele Russo14, Stefania Taddei20, Carlo Alberto Volta3, V Marco Ranieri9. 1. Department of Anaesthesia, Intensive Care and Prehospital Emergency, Ospedale Maggiore Carlo Alberto Pizzardi, Bologna, Italy. 2. Alma Mater Studiorum, Dipartimento di Scienze Mediche e Chirurgiche, Anesthesia and Intensive Care Medicine, Policlinico di Sant'Orsola, Università di Bologna, Bologna, Italy. tommaso.tonetti@unibo.it. 3. Department of Morphology, Surgery and Experimental Medicine, Section of Anaesthesia and Intensive Care University of Ferrara, Azienda Ospedaliero-Universitaria S. Anna, Via Aldo Moro, 8, 44121, Ferrara, Cona, Italy. 4. Department of Anesthesia and Intensive Care, Santa Maria delle Croci Hospital, Ravenna, Italy. 5. Cardio-Anesthesiology Unit, Cardio-Thoracic-Vascular Department, S.Orsola Hospital, University of Bologna, Bologna, Italy. 6. Radiology Department, M.Bufalini Hospital, Cesena, Italy. 7. Alma Mater University, Department of Clinical, Integrated and Experimental Medicine (DIMES), Statistical Service, S. Orsola-Malpighi Hospital Bologna, Bologna, Italy. 8. Department of Anaesthesiology, University Hospital of Modena, Via del Pozzo 71, 41100, Modena, Italy. 9. Alma Mater Studiorum, Dipartimento di Scienze Mediche e Chirurgiche, Anesthesia and Intensive Care Medicine, Policlinico di Sant'Orsola, Università di Bologna, Bologna, Italy. 10. Anaesthesia and Intensive Care Department, SS. Trinità Hospital, ASL, Novara, Italy. 11. Translational Medicine Department, Eastern Piedmont University, Novara, Italy. 12. Anaesthesia and Intensive Care Residency Program - Translational Medicine Department, Eastern Piedmont University, Novara, Italy. 13. Department of Anaesthesia, Intensive Care and Pain Therapy - Imola Hospital, Imola, Italy. 14. Anaesthesia and Intensive Care Unit, M. Bufalini Hospital, Cesena, Italy. 15. Division of Anesthesiology, Hospital S. Orsola Malpighi, Alma Mater Studiorum University of Bologna, Bologna, Italy. 16. Department of Anesthesia and Intensive Care, G.B. Morgagni-Pierantoni Hospital, Forlì, Italy. 17. Department of Anaesthesia and Intensive Care, Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo, Alessandria, Italy. 18. Department of Anaesthesia and Intensive Care, Infermi Hospital, Rimini, Italy. 19. Anaesthesia and Intensive Care Unit, Santa Maria Annunziata Hospital, Firenze, Italy. 20. Anaesthesia and Intensive Care Unit, Bentivoglio Hospital, Bentivoglio, Italy.
Abstract
BACKGROUND: A large proportion of patients with coronavirus disease 2019 (COVID-19) develop severe respiratory failure requiring admission to the intensive care unit (ICU) and about 80% of them need mechanical ventilation (MV). These patients show great complexity due to multiple organ involvement and a dynamic evolution over time; moreover, few information is available about the risk factors that may contribute to increase the time course of mechanical ventilation. The primary objective of this study is to investigate the risk factors associated with the inability to liberate COVID-19 patients from mechanical ventilation. Due to the complex evolution of the disease, we analyzed both pulmonary variables and occurrence of non-pulmonary complications during mechanical ventilation. The secondary objective of this study was the evaluation of risk factors for ICU mortality. METHODS: This multicenter prospective observational study enrolled 391 patients from fifteen COVID-19 dedicated Italian ICUs which underwent invasive mechanical ventilation for COVID-19 pneumonia. Clinical and laboratory data, ventilator parameters, occurrence of organ dysfunction, and outcome were recorded. The primary outcome measure was 28 days ventilator-free days and the liberation from MV at 28 days was studied by performing a competing risks regression model on data, according to the method of Fine and Gray; the event death was considered as a competing risk. RESULTS: Liberation from mechanical ventilation was achieved in 53.2% of the patients (208/391). Competing risks analysis, considering death as a competing event, demonstrated a decreased sub-hazard ratio for liberation from mechanical ventilation (MV) with increasing age and SOFA score at ICU admission, low values of PaO2/FiO2 ratio during the first 5 days of MV, respiratory system compliance (CRS) lower than 40 mL/cmH2O during the first 5 days of MV, need for renal replacement therapy (RRT), late-onset ventilator-associated pneumonia (VAP), and cardiovascular complications. ICU mortality during the observation period was 36.1% (141/391). Similar results were obtained by the multivariate logistic regression analysis using mortality as a dependent variable. CONCLUSIONS: Age, SOFA score at ICU admission, CRS, PaO2/FiO2, renal and cardiovascular complications, and late-onset VAP were all independent risk factors for prolonged mechanical ventilation in patients with COVID-19. TRIAL REGISTRATION: NCT04411459.
BACKGROUND: A large proportion of patients with coronavirus disease 2019 (COVID-19) develop severe respiratory failure requiring admission to the intensive care unit (ICU) and about 80% of them need mechanical ventilation (MV). These patients show great complexity due to multiple organ involvement and a dynamic evolution over time; moreover, few information is available about the risk factors that may contribute to increase the time course of mechanical ventilation. The primary objective of this study is to investigate the risk factors associated with the inability to liberate COVID-19 patients from mechanical ventilation. Due to the complex evolution of the disease, we analyzed both pulmonary variables and occurrence of non-pulmonary complications during mechanical ventilation. The secondary objective of this study was the evaluation of risk factors for ICU mortality. METHODS: This multicenter prospective observational study enrolled 391 patients from fifteen COVID-19 dedicated Italian ICUs which underwent invasive mechanical ventilation for COVID-19 pneumonia. Clinical and laboratory data, ventilator parameters, occurrence of organ dysfunction, and outcome were recorded. The primary outcome measure was 28 days ventilator-free days and the liberation from MV at 28 days was studied by performing a competing risks regression model on data, according to the method of Fine and Gray; the event death was considered as a competing risk. RESULTS: Liberation from mechanical ventilation was achieved in 53.2% of the patients (208/391). Competing risks analysis, considering death as a competing event, demonstrated a decreased sub-hazard ratio for liberation from mechanical ventilation (MV) with increasing age and SOFA score at ICU admission, low values of PaO2/FiO2 ratio during the first 5 days of MV, respiratory system compliance (CRS) lower than 40 mL/cmH2O during the first 5 days of MV, need for renal replacement therapy (RRT), late-onset ventilator-associated pneumonia (VAP), and cardiovascular complications. ICU mortality during the observation period was 36.1% (141/391). Similar results were obtained by the multivariate logistic regression analysis using mortality as a dependent variable. CONCLUSIONS: Age, SOFA score at ICU admission, CRS, PaO2/FiO2, renal and cardiovascular complications, and late-onset VAP were all independent risk factors for prolonged mechanical ventilation in patients with COVID-19. TRIAL REGISTRATION: NCT04411459.
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