Rosanna Vaschetto1,2, Federico Longhini3, Paolo Persona4, Carlo Ori5, Giulia Stefani5, Songqiao Liu6, Yang Yi6, Weihua Lu7, Tao Yu7, Xiaoming Luo8, Rui Tang8, Maoqin Li9, Jiaqiong Li9, Gianmaria Cammarota1, Andrea Bruni10, Eugenio Garofalo10, Zhaochen Jin11, Jun Yan11, Ruiqiang Zheng12, Jingjing Yin12, Stefania Guido1, Francesco Della Corte1,2, Tiziano Fontana13, Cesare Gregoretti14, Andrea Cortegiani14, Antonino Giarratano14, Claudia Montagnini1, Silvio Cavuto15, Haibo Qiu6, Paolo Navalesi16. 1. Azienda Ospedaliero Universitaria "Maggiore Della Carità", Anestesia e Terapia Intensiva, Corso Mazzini 18, Novara, Italy. 2. Università del Piemonte Orientale, via Solaroli 17, Novara, Italy. 3. Ospedale Sant'Andrea, Anestesia e Rianimazione, Corso Abbiate 21, Vercelli, Italy. 4. Emergency Department, Azienda Ospedaliera di Padova, Via Giustiniani 2, Padua, Italy. 5. Department of Medicine, DIMED, University of Padova, Via Giustiniani 2, Padua, Italy. 6. Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University, Nanjing, 210009, Jiangsu, China. 7. Department of Critical Care Medicine, The First Affiliated Hospital of Wannan Medical College, Wuhu, 241001, Anhui, China. 8. Department of Critical Care Medicine, The First Affiliated Hospital of Anhui Medical University, Hefei, 230022, Anhui, China. 9. Department of Critical Care Medicine, Xuzhou Central Hospital, Xuzhou, 221009, Jiangsu, China. 10. Anestesia e Rianimazione, Dipartimento di Scienze Mediche e Chirurgiche, Università "Magna Graecia", Viale Europa (Loc. Germaneto), Catanzaro, Italy. 11. Department of Critical Care Medicine, Zhenjiang First People's Hospital, Zhenjiang, 212002, Jiangsu, China. 12. Department of Critical Care Medicine, Northern Jiangsu People's Hospital, Yangzhou, 225000, Jiangsu, China. 13. Azienda Sanitaria Locale del Verbano Cusio Ossola, Anestesia e Rianimazione, Piazza Vittime dei Lager Nazifascisti 1, Domodossola, Italy. 14. Department of Biopathology and Medical Biotechnologies (DIBIMED), Section of Anesthesia, Analgesia, Intensive Care and Emergency, Policlinico Paolo Giaccone, University of Palermo, Via del Vespro 129, Palermo, Italy. 15. Azienda Unità Sanitaria Locale di Reggio Emilia-IRCCS, S.C. Infrastruttura Ricerca e Statistica, Via Amendola 2, Reggio Emilia, Italy. 16. Anestesia e Rianimazione, Dipartimento di Scienze Mediche e Chirurgiche, Università "Magna Graecia", Viale Europa (Loc. Germaneto), Catanzaro, Italy. pnavalesi@unicz.it.
Abstract
PURPOSE:Noninvasive ventilation (NIV) may facilitate withdrawal of invasive mechanical ventilation (i-MV) and shorten intensive care unit (ICU) length of stay (LOS) in hypercapnic patients, while data are lacking on hypoxemic patients. We aim to determine whether NIV after early extubation reduces the duration of i-MV and ICU LOS in patients recovering from hypoxemic acute respiratory failure. METHODS:Highly selected non-hypercapnic hypoxemic patients were randomly assigned to receive NIV after early or standard extubation. Co-primary end points were duration of i-MV and ICU LOS. Secondary end points were treatment failure, severe events (hemorrhagic, septic, cardiac, renal or neurologic episodes, pneumothorax or pulmonary embolism), ventilator-associated pneumonia (VAP) or tracheobronchitis (VAT), tracheotomy, percent of patients receiving sedation after study enrollment, hospital LOS, and ICU and hospital mortality. RESULTS: We enrolled 130 consecutive patients, 65 treatments and 65 controls. Duration of i-MV was shorter in the treatment group than for controls [4.0 (3.0-7.0) vs. 5.5 (4.0-9.0) days, respectively, p = 0.004], while ICU LOS was not significantly different [8.0 (6.0-12.0) vs. 9.0 (6.5-12.5) days, respectively (p = 0.259)]. Incidence of VAT or VAP (9% vs. 25%, p = 0.019), rate of patients requiring infusion of sedatives after enrollment (57% vs. 85%, p = 0.001), and hospital LOS, 20 (13-32) vs. 27(18-39) days (p = 0.043) were all significantly reduced in the treatment group compared with controls. There were no significant differences in ICU and hospital mortality or in the number of treatment failures, severe events, and tracheostomies. CONCLUSIONS: In highly selected hypoxemic patients, early extubation followed by immediate NIV application reduced the days spent on invasive ventilation without affecting ICU LOS.
RCT Entities:
PURPOSE: Noninvasive ventilation (NIV) may facilitate withdrawal of invasive mechanical ventilation (i-MV) and shorten intensive care unit (ICU) length of stay (LOS) in hypercapnic patients, while data are lacking on hypoxemic patients. We aim to determine whether NIV after early extubation reduces the duration of i-MV and ICU LOS in patients recovering from hypoxemic acute respiratory failure. METHODS: Highly selected non-hypercapnic hypoxemicpatients were randomly assigned to receive NIV after early or standard extubation. Co-primary end points were duration of i-MV and ICU LOS. Secondary end points were treatment failure, severe events (hemorrhagic, septic, cardiac, renal or neurologic episodes, pneumothorax or pulmonary embolism), ventilator-associated pneumonia (VAP) or tracheobronchitis (VAT), tracheotomy, percent of patients receiving sedation after study enrollment, hospital LOS, and ICU and hospital mortality. RESULTS: We enrolled 130 consecutive patients, 65 treatments and 65 controls. Duration of i-MV was shorter in the treatment group than for controls [4.0 (3.0-7.0) vs. 5.5 (4.0-9.0) days, respectively, p = 0.004], while ICU LOS was not significantly different [8.0 (6.0-12.0) vs. 9.0 (6.5-12.5) days, respectively (p = 0.259)]. Incidence of VAT or VAP (9% vs. 25%, p = 0.019), rate of patients requiring infusion of sedatives after enrollment (57% vs. 85%, p = 0.001), and hospital LOS, 20 (13-32) vs. 27(18-39) days (p = 0.043) were all significantly reduced in the treatment group compared with controls. There were no significant differences in ICU and hospital mortality or in the number of treatment failures, severe events, and tracheostomies. CONCLUSIONS: In highly selected hypoxemic patients, early extubation followed by immediate NIV application reduced the days spent on invasive ventilation without affecting ICU LOS.
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