Jean-Pierre Frat1, Jean-Damien Ricard2, Jean-Pierre Quenot3, Nicolas Pichon4, Alexandre Demoule5, Jean-Marie Forel6, Jean-Paul Mira7, Rémi Coudroy8, Guillaume Berquier2, Benoit Voisin9, Gwenhaël Colin10, Bertrand Pons11, Pierre Eric Danin12, Jérome Devaquet13, Gwenael Prat14, Raphaël Clere-Jehl15, Franck Petitpas16, Emmanuel Vivier17, Keyvan Razazi18, Mai-Anh Nay19, Vincent Souday20, Jean Dellamonica21, Laurent Argaud22, Stephan Ehrmann23, Aude Gibelin24, Christophe Girault25, Pascal Andreu26, Philippe Vignon27, Laurence Dangers28, Stéphanie Ragot29, Arnaud W Thille8. 1. CHU de Poitiers, Médecine Intensive Réanimation, Poitiers, France; équipe 5 ALIVE, INSERM, CIC-1402, Poitiers, France; Faculté de Médecine et de Pharmacie de Poitiers, Université de Poitiers, Poitiers, France. Electronic address: jean-pierre.frat@chu-poitiers.fr. 2. Assistance Publique des Hôpitaux de Paris, Hôpital Louis Mourier, Service de Réanimation Médico-Chirurgicale, Colombes, France; Université Paris Diderot, UMR IAME 1137, Sorbonne Paris Cité, Paris, France. 3. CHU Dijon Bourgogne, Service de Médecine Intensive Réanimation, Dijon, France; Université Bourgogne Franche-Comté Lipness Team, UMR 1231 et INSERM CIC 1432 Epidémiologie Clinique, Dijon, France. 4. CHU Dupuytren, Réanimation Polyvalente, Limoges, France. 5. Assistance Publique-Hôpitaux de Paris, Groupe Hospitalier Pitié-Salpêtrière Charles Foix, Service de Pneumologie et Réanimation Médicale du Département R3S, Paris, France; Sorbonne Université, INSERM, UMRS1158 Neurophysiologie Respiratoire Expérimentale et Clinique, Paris, France. 6. Réanimation des Détresses Respiratoires et Infections Sévères, Hôpital Nord-Assistance Publique-Hôpitaux de Marseille, Marseille, France; Aix-Marseille Université, Marseille, France. 7. Assistance Publique des Hôpitaux de Paris, Groupe Hospitalier Universitaire de Paris Centre, Hôpital Cochin, Réanimation Médicale, Paris, France; Faculté de Médecine, Université Paris Descartes, Paris, France. 8. CHU de Poitiers, Médecine Intensive Réanimation, Poitiers, France; équipe 5 ALIVE, INSERM, CIC-1402, Poitiers, France; Faculté de Médecine et de Pharmacie de Poitiers, Université de Poitiers, Poitiers, France. 9. CHRU de Lille, Centre de Réanimation, Lille, France. 10. Centre Hospitalier Départemental de La Roche sur Yon, Service de Réanimation Polyvalente, La Roche sur Yon, France. 11. Service de Réanimation, CHU Point-à-Pitre, Pointe-à-Pitre, Guadeloupe, France. 12. Réanimation Chirurgicale, CHU de Nice, Nice, France; INSERM U1065, Team 8, C3M, Nice, France. 13. Hôpital Foch, Réanimation Polyvalente, Suresnes, France. 14. CHU de la Cavale Blanche, Service de Réanimation Médicale, Brest, France. 15. Service de Réanimation, Nouvel Hôpital Civil, Strasbourg, France; Université de Strasbourg, Faculté de Médecine, Hôpitaux Universitaires de Strasbourg, Strasbourg, France. 16. CHU Poitiers, Réanimation Chirurgicale, Poitiers, France. 17. Centre Hospitalier Saint Joseph-Saint Luc, Service de Réanimation Polyvalente, Lyon, France. 18. Assistance Publique des Hôpitaux de Paris, CHU Henri Mondor, DHU A-TVB, Service de Réanimation Médicale, Créteil, France; Université Paris Est Créteil, Faculté de Médecine de Créteil, Groupe de Recherche Clinique CARMAS, Créteil, France; INSERM, Unité UMR 955, IMRB, Créteil France. 19. Centre Hospitalier Régional d'Orléans, Service de Médecine Intensive réanimation, Orléans, France. 20. CHU Angers, Service de Réanimation Médicale et Médecine Hyperbare, Angers, France. 21. CHU Nice, Service de Médecine Intensive et Réanimation, Nice, France. 22. Hospices Civils de Lyon, Groupement Hospitalier Universitaire Edouard Herriot, Service de Réanimation Médicale, Lyon, France. 23. CHRU de Tours, Médecine Intensive Réanimation, Tours, France; Université de Tours, Centre d'Etudes des Pathologies Respiratoires, INSERM U1100, Tours, France. 24. Assistance Publique des Hôpitaux de Paris, Hôpital Tenon, Service de Réanimation, pneumologique, Paris, France. 25. Normandie Univ, UNIROUEN, Department of Medical Intensive Care, Charles Nicolle University, Rouen, France; CHU de Rouen, Rouen, France; EA3830-GRHV, Institute for Research and Innovation in Biomedicine, Rouen University, Rouen, France. 26. CHU Dijon Bourgogne, Service de Médecine Intensive Réanimation, Dijon, France. 27. CHU Dupuytren, Réanimation Polyvalente, Limoges, France; Clinical Investigation Centre INSERM 1435, Limoges, France. 28. Assistance Publique-Hôpitaux de Paris, Groupe Hospitalier Pitié-Salpêtrière Charles Foix, Service de Pneumologie et Réanimation Médicale du Département R3S, Paris, France. 29. Biostatistics, INSERM, CIC-1402, Poitiers, France; Faculté de Médecine et de Pharmacie de Poitiers, Université de Poitiers, Poitiers, France.
Abstract
BACKGROUND: Non-invasive ventilation has never been compared with high-flow oxygen to determine whether it reduces the risk of severe hypoxaemia during intubation. We aimed to determine if preoxygenation with non-invasive ventilation was more efficient than high-flow oxygen in reducing the risk of severe hypoxaemia during intubation. METHODS: The FLORALI-2 multicentre, open-label trial was done in 28 intensive care units in France. Adult patients undergoingtracheal intubation for acute hypoxaemic respiratory failure (a partial pressure of arterial oxygen [PaO2] to fraction of inspired oxygen [FiO2] ratio of ≤300 mm Hg) were randomly assigned (1:1; block size, four participants) to non-invasive ventilation or high-flow oxygen during preoxygenation, with stratification by PaO2/FiO2 ratio (≤200 mm Hg vs >200 mm Hg). Key exclusion criteria were intubation for cardiac arrest, altered consciousness (defined as a Glasgow coma score of less than eight points), other contraindications to non-invasive ventilation (recent laryngeal, oesophageal, or gastric surgery, and substantial facial fractures), pulse oximetry not available, pregnant or breastfeeding women, and refusal to participate. The primary outcome was the occurrence of severe hypoxaemia (pulse oximetry <80%) during the procedure, assessed in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, number NCT02668458. FINDINGS:Between April 15, 2016, and Jan 8, 2017, 2079 patients were intubated in the 28 participating units, and 322 were enrolled. We excluded five patients with no recorded data, two who withdrew consent or were under legal protection, one who was not intubated, and one who had a cardiac arrest. Of the 313 patients included in the intention-to-treat analysis, 142 were assigned to non-invasive ventilation and 171 to high-flow oxygen therapy. Severe hypoxaemia occurred in 33 (23%) of 142 patients after preoxygenation with non-invasive ventilation and 47 (27%) of 171 with high-flow oxygen (absolute difference -4·2%, 95% CI -13·7 to 5·5; p=0·39). In the 242 patients with moderate-to-severe hypoxaemia (PaO2/FiO2 ≤200 mm Hg), severe hypoxaemia occurred less frequently after preoxygenation with non-invasive ventilation than with high-flow oxygen (28 [24%] of 117 patients vs 44 [35%] of 125; adjusted odds ratio 0·56, 0·32 to 0·99, p=0·0459). Serious adverse events did not differ between treatment groups, with the most common immediate complications being systolic arterial hypotension (70 [49%] patients in the non-invasive ventilation group vs 86 [50%] patients in the high-flow oxygen group) and chest infiltrate on x-ray (28 [20%] vs 33 [19%]), and the most common late complications being death at day 28 (53 [37%] vs 58 [34%]) and ventilator-associated pneumonia during ICU stay (31 [22%] vs 35 [20%]). INTERPRETATION: In patients with acute hypoxaemic respiratory failure, preoxygenation with non-invasive ventilation or high-flow oxygen therapy did not change the risk of severe hypoxaemia. Future research should explore the effect of preoxygenation method in patients with moderate-to-severe hypoxaemia at baseline. FUNDING: French Ministry of Health.
RCT Entities:
BACKGROUND: Non-invasive ventilation has never been compared with high-flow oxygen to determine whether it reduces the risk of severe hypoxaemia during intubation. We aimed to determine if preoxygenation with non-invasive ventilation was more efficient than high-flow oxygen in reducing the risk of severe hypoxaemia during intubation. METHODS: The FLORALI-2 multicentre, open-label trial was done in 28 intensive care units in France. Adult patients undergoing tracheal intubation for acute hypoxaemic respiratory failure (a partial pressure of arterial oxygen [PaO2] to fraction of inspired oxygen [FiO2] ratio of ≤300 mm Hg) were randomly assigned (1:1; block size, four participants) to non-invasive ventilation or high-flow oxygen during preoxygenation, with stratification by PaO2/FiO2 ratio (≤200 mm Hg vs >200 mm Hg). Key exclusion criteria were intubation for cardiac arrest, altered consciousness (defined as a Glasgow coma score of less than eight points), other contraindications to non-invasive ventilation (recent laryngeal, oesophageal, or gastric surgery, and substantial facial fractures), pulse oximetry not available, pregnant or breastfeeding women, and refusal to participate. The primary outcome was the occurrence of severe hypoxaemia (pulse oximetry <80%) during the procedure, assessed in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, number NCT02668458. FINDINGS: Between April 15, 2016, and Jan 8, 2017, 2079 patients were intubated in the 28 participating units, and 322 were enrolled. We excluded five patients with no recorded data, two who withdrew consent or were under legal protection, one who was not intubated, and one who had a cardiac arrest. Of the 313 patients included in the intention-to-treat analysis, 142 were assigned to non-invasive ventilation and 171 to high-flow oxygen therapy. Severe hypoxaemia occurred in 33 (23%) of 142 patients after preoxygenation with non-invasive ventilation and 47 (27%) of 171 with high-flow oxygen (absolute difference -4·2%, 95% CI -13·7 to 5·5; p=0·39). In the 242 patients with moderate-to-severe hypoxaemia (PaO2/FiO2 ≤200 mm Hg), severe hypoxaemia occurred less frequently after preoxygenation with non-invasive ventilation than with high-flow oxygen (28 [24%] of 117 patients vs 44 [35%] of 125; adjusted odds ratio 0·56, 0·32 to 0·99, p=0·0459). Serious adverse events did not differ between treatment groups, with the most common immediate complications being systolic arterial hypotension (70 [49%] patients in the non-invasive ventilation group vs 86 [50%] patients in the high-flow oxygen group) and chest infiltrate on x-ray (28 [20%] vs 33 [19%]), and the most common late complications being death at day 28 (53 [37%] vs 58 [34%]) and ventilator-associated pneumonia during ICU stay (31 [22%] vs 35 [20%]). INTERPRETATION: In patients with acute hypoxaemic respiratory failure, preoxygenation with non-invasive ventilation or high-flow oxygen therapy did not change the risk of severe hypoxaemia. Future research should explore the effect of preoxygenation method in patients with moderate-to-severe hypoxaemia at baseline. FUNDING: French Ministry of Health.
Authors: Kenneth E Remy; Philip A Verhoef; Jay R Malone; Michael D Ruppe; Timothy B Kaselitz; Frank Lodeserto; Eliotte L Hirshberg; Anthony Slonim; Cameron Dezfulian Journal: Pediatr Crit Care Med Date: 2020-07 Impact factor: 3.624
Authors: Jozef Klucka; Martina Kosinova; Kai Zacharowski; Stefan De Hert; Milan Kratochvil; Michaela Toukalkova; Roman Stoudek; Hana Zelinkova; Petr Stourac Journal: Eur J Anaesthesiol Date: 2020-06 Impact factor: 4.183