C Baillard1, G Prat2, B Jung3, E Futier4, J Y Lefrant5, F Vincent6, A Hamdi7, E Vicaut8, S Jaber3. 1. Department of Surgical Critical Care Medicine and Anesthesiology, Cochin University Hospital, Paris 5 Descartes University, Assistance Publique-Hôpitaux de Paris, France. Electronic address: christophe.baillard@aphp.fr. 2. Medical Intensive Care Unit, Cavale Blanche University Hospital, Brest, France. 3. Department of Critical Care Medicine and Anesthesiology (DAR B), Saint Eloi University Hospital and Montpellier School of Medicine, Medical Intensive Care Unit, Lapeyronie Teaching Hospital, INSERM U-1046/CNRS U-9234, Montpellier University, Montpellier, France. 4. Department of Perioperative Medicine, Anesthesiology and Critical Care Medicine, Estaing University Hospital and Clermont-Ferrand School of Medicine, Research Unit R2D2, EA 7281, Clermont-Ferrand, France. 5. Intensive Care Unit, Division of Anaesthesia Critical Care and Emergency and Pain Medicine, University Hospital, Nîmes, France. 6. Intensive Care Unit, Avicenne University Hospital, Bobigny, France. 7. Intensive Care Unit, André Grégoire Hospital, Montreuil, France. 8. Unité de Recherche Clinique, Lariboisière University Hospital, Paris, France.
Abstract
BACKGROUND: Previous data showed that non-invasive ventilation (NIV) applied for 3 min before tracheal intubation ensured better oxygenation compared with using a non-rebreather bag-valve-mask. We aimed to determine whether preoxygenation using NIV is effective in reducing the incidence of organ dysfunction in hypoxaemic, critically ill patients in intensive care. METHODS: A multicentre, randomised, open-label trial evaluating 100% FiO2 administered with NIV (99 patients) vs with face mask (102 patients) for 3 min before tracheal intubation. The primary endpoint was the maximal value of Sequential Organ Failure Assessment score within 7 days after intubation. RESULTS: The median (inter-quartile range) values of the maximal value of the Sequential Organ Failure Assessment score within 7 days post-intubation were not significantly different between the two randomised groups: nine (6-12) in the NIV group vs 10 (6-12) in the face mask group (P=0.65). In patients treated by NIV prior to the randomisation, there was a significant increase in the occurrence in adverse events in patients randomised to face mask [odds ratio=5.23 (1.61;16.99), P=0.0059]. CONCLUSIONS: This study failed to demonstrate any benefits of using NIV as a preoxygenation method to reduce organ dysfunction compared with usual preoxygenation in hypoxaemic, critically ill patients requiring tracheal intubation for invasive ventilation. NIV should not be discontinued for preoxygenation in the cases of patients treated by NIV before the decision to intubate. CLINICAL TRIAL REGISTRATION: NCT00472160.
RCT Entities:
BACKGROUND: Previous data showed that non-invasive ventilation (NIV) applied for 3 min before tracheal intubation ensured better oxygenation compared with using a non-rebreather bag-valve-mask. We aimed to determine whether preoxygenation using NIV is effective in reducing the incidence of organ dysfunction in hypoxaemic, critically illpatients in intensive care. METHODS: A multicentre, randomised, open-label trial evaluating 100% FiO2 administered with NIV (99 patients) vs with face mask (102 patients) for 3 min before tracheal intubation. The primary endpoint was the maximal value of Sequential Organ Failure Assessment score within 7 days after intubation. RESULTS: The median (inter-quartile range) values of the maximal value of the Sequential Organ Failure Assessment score within 7 days post-intubation were not significantly different between the two randomised groups: nine (6-12) in the NIV group vs 10 (6-12) in the face mask group (P=0.65). In patients treated by NIV prior to the randomisation, there was a significant increase in the occurrence in adverse events in patients randomised to face mask [odds ratio=5.23 (1.61;16.99), P=0.0059]. CONCLUSIONS: This study failed to demonstrate any benefits of using NIV as a preoxygenation method to reduce organ dysfunction compared with usual preoxygenation in hypoxaemic, critically illpatients requiring tracheal intubation for invasive ventilation. NIV should not be discontinued for preoxygenation in the cases of patients treated by NIV before the decision to intubate. CLINICAL TRIAL REGISTRATION: NCT00472160.