Introduction: Neonatal and infant anaesthesia are associated with a high risk of perioperative complications. The aim of the current study was to describe those risks in France using the French data from the NECTARINE study. Material and methods: Data from the French centres that participated to the NECTARINE study were analysed. The primary goal of the study was the description of patients' characteristics, procedures and perioperative management and their comparison with the results of the European NECTARINE study. Secondary outcomes were the description of major perioperative complications and death. Results: Overall, 926 procedures collected in 15 centres (all teaching hospitals) were analysed. Comparison between the French and European NECTARINE cohorts found few differences related to patients' characteristics and procedures. The rate of interventions for critical events (respiratory, haemodynamic, and metabolic) was similar between the two cohorts. Near-infrared spectroscopy monitoring was used in 12% of procedures. Nearly none of the thresholds for these interventions met the published standards. By day 30, complications (respiratory, haemodynamic, metabolic, renal, and liver failure) and death were observed in 14.4% [95% CI 11.6-16.4]% and 1.8% [95% CI 1.1-2.9] of cases, respectively. Discussion: Although the health status of the patients in the French cohort was less severe, procedures, management and postoperative complications and mortality rates were similar to the European cohort. However, thresholds for interventions were often inadequate in both cohorts. Efforts should be undertaken to improve the knowledge and use of new monitoring devices in this population. (C) 2022 Societe francaise d'anesthesie et de reanimation (Sfar). Published by Elsevier Masson SAS. All rights reserved.

Introduction: Analysing national patients' profile and organisation of human resources are important for improving the perioperative quality of care. The aim of the current study was to achieve these goals using the French data from the APRICOT study. Material and methods: Data from the French centres that participated to the APRICOT study were extracted and analysed. The primary goal of the study was to describe patients characteristics, procedures and perioperative anaesthetic management in France, and compare them to the results of the European APRICOT trial. Secondary outcomes were the description of major perioperative complications and the determination of human resources organisation possibly associated with these perioperative complications. Results: Overall 3535 procedures collected in 20 facilities (17 teaching hospitals, one community hospital and two private institutions) were analysed. Comparison between the French and European APRICOT cohorts found differences related to the more specialised French centres participating to the study. Overall complications (respiratory complications, haemodynamic instability, cardiac arrest, drug errors, and anaphylactic reactions) were observed in 6.4% [95% CI: 5.6; 6.3] of cases. Multivariate analysis identified the anaesthesiologist's experience of < 15 years and the absence of an anaesthetic nurse as human factors independently associated with an increased risk for perioperative complications. Discussion: The current study identified some important differences between the French and the whole APRICOT cohort in terms of preoperative evaluation, surgical specialties involved, and monitoring of neuromuscular blockade. It confirms that, in France, the presence of an anaesthetic nurse and an experienced anaesthesiologist prevents anaesthetic complications. (C) 2019 Societe francaise d'anesthesie et de reanimation (Sfar). Published by Elsevier Masson SAS. All rights reserved.

Background Little is known about the incidence of severe critical events in children undergoing general anaesthesia in Europe. We aimed to identify the incidence, nature, and outcome of severe critical events in children undergoing anaesthesia, and the associated potential risk factors.Methods The APRICOT study was a prospective observational multicentre cohort study of children from birth to 15 years of age undergoing elective or urgent anaesthesia for diagnostic or surgical procedures. Children were eligible for inclusion during a 2-week period determined prospectively by each centre. There were 261 participating centres across 33 European countries. The primary endpoint was the occurence of perioperative severe critical events requiring immediate intervention. A severe critical event was defined as the occurrence of respiratory, cardiac, allergic, or neurological complications requiring immediate intervention and that led (or could have led) to major disability or death. This study is registered with ClinicalTrials.gov, number NCT01878760.Findings Between April 1, 2014, and Jan 31, 2015, 31 127 anaesthetic procedures in 30 874 children with a mean age of 6.35 years (SD 4.50) were included. The incidence of perioperative severe critical events was 5.2% (95% CI 5.0-5.5) with an incidence of respiratory critical events of 3.1% (2.9-3.3). Cardiovascular instability occurred in 1.9% (1.7-2.1), with an immediate poor outcome in 5.4% (3.7-7.5) of these cases. The all-cause 30-day in-hospital mortality rate was 10 in 10 000. This was independent of type of anaesthesia. Age (relative risk 0.88, 95% CI 0.86-0.90; p<0.0001), medical history, and physical condition (1.60, 1.40-1.82; p<0.0001) were the major risk factors for a serious critical event. Multivariate analysis revealed evidence for the beneficial effect of years of experience of the most senior anaesthesia team member (0.99, 0.981-0.997; p<0.0048 for respiratory critical events, and 0.98, 0.97-0.99; p=0.0039 for cardiovascular critical events), rather than the type of health institution or providers.Interpretation This study highlights a relatively high rate of severe critical events during the anaesthesia management of children for surgical or diagnostic procedures in Europe, and a large variability in the practice of paediatric anaesthesia. These findings are substantial enough to warrant attention from national, regional, and specialist societies to target education of anaesthesiologists and their teams and implement strategies for quality improvement in paediatric anaesthesia.

Conformément aux recommandations de la SFAR, le midazolam peut-être utilisé comme agent de sédation vigile au cours de la prémédication pédiatrique. Pour faciliter son administration orale, une formulation originale de midazolam à 0,2 % (m/v) a été développée (Ozaline®). Afin d'étudier cette nouvelle formulation chez l'enfant, une étude clinique de phase II de pharmacocinétique chez les adolescents (âgés de 12 à 17 ans) et chez les enfants (âgés de 6 mois à 11 ans) a été réalisée. L'étude a été réalisée chez l'enfant de 6 mois à 11 ans (n = 25) et chez l'adolescent de 12 à 17 ans (n = 12). Une dose unique de 0,3 mg/kg (maximum 10 mg) de formulation originale a été administrée par voie orale, puis les concentrations plasmatiques de midazolam et d'α-hydroxymidazolam ont été mesurées. Pour cela, 11 prélèvements sanguins ont été réalisés chez l'adolescent de 12 à 17 ans aux temps t = 0, 5, 10, 30, 45, 60, 90, 120, 180, 240, 360 min. Pour les enfants de 6 mois à 11 ans, 4 prélèvements étaient réalisés parmi ces mêmes temps. Une étude en pharmacocinétique de population a été réalisée avec le logiciel MONOLIX en incluant des données pharmacocinétiques issues d'une étude de phase I chez le volontaire sain (n = 12, âge 18–55 ans). Des données d'efficacité (score OAA/S de sédation et score mYPAS d'anxiolyse), d'acceptabilité ont été recueillies parallèlement. Chez les adolescents, la concentration plasmatique maximale était atteinte en 45 min et la demi-vie d'élimination était de 3,56 h en moyenne. Un modèle pharmacocinétique avec un compartiment central, un compartiment périphérique et 3 compartiments dépôts, a permis de prédire les concentrations observées lors de l'analyse en pharmacocinétique de population. La majorité de la dose (77 %) atteignant la circulation systémique était absorbée avant 30 min. La clairance (CL/F) du midazolam était proche de 34,7 L/h. Les volumes de distribution centraux (Vc/F) et périphériques (Vp) étaient estimés respectivement à 27,9 L et 413 L pour un sujet de 34 kg. La clairance plasmatique de l'α-hydroxymidazolam (CL/F) était de 40 L/h. Une sédation satisfaisante (Score OAA/S ≤ 17) était observée chez 78,4 % des patients 30 minutes après l'administration de midazolam (soit 87,5 % des nourrissons [6–23 mois], 70,6 % des enfants [2–11 ans] et 83,3 % des adolescents [12–17 ans]). Le score d'anxiété était diminué de 18,3 % en moyenne par rapport à la valeur de base, 30 minutes après l'administration du midazolam avec un effet plus marqué chez les enfants les plus jeunes qui étaient également les plus anxieux avant l'administration de midazolam. Le traitement a été bien accepté par l'ensemble des enfants et n'a pas induit plus de pleurs et de nausées/vomissements qu'avant l'administration de midazolam (Fig. 1). Le midazolam contenu dans cette nouvelle formulation était absorbé rapidement. La concentration plasmatique maximale était atteinte entre 35 et 45 minutes et produisait un effet anxiolytique et sédatif rapide, dans les 30 minutes suivant son administration. Les données d'acceptabilité et de sécurité d'emploi sont encourageantes.

Introduction The aim of this study was to evaluate the prognostic value of optic nerve sheath diameter (ONSD) measured on the initial brain computed tomography (CT) scan for intensive care unit (ICU) mortality in severe traumatic brain injury (TBI) patients. Methods A prospective observational study of all severe TBI patients admitted to a neurosurgical ICU (over a 10-month period). Demographic and clinical data and brain CT scan results were recorded. ONSD for each eye was measured on the initial CT scan. The group of ICU survivors was compared to non-survivors. Glasgow Outcome Scale (GOS) was evaluated six months after ICU discharge. Results Seventy-seven patients were included (age: 43 ± 18; 81% males; mean Injury Severity Score: 35 ± 15; ICU mortality: 28.5% ( n = 22)). Mean ONSD on the initial brain CT scan was 7.8 ± 0.1 mm in non-survivors vs. 6.8 ± 0.1 mm in survivors ( P < 0.001). The operative value of ONSD was a good predictor of mortality (area under the curve: 0.805). An ONSD cutoff ≥ 7.3 had a sensitivity of 86.4% and a specificity of 74.6% and was independently associated with mortality in this population (adjusted odds ratio 95% confidence interval: 22.7 (3.2 to 159.6), P = 0.002). There was a relationship between initial ONSD values and six-month GOS ( P = 0.03). Conclusions ONSD measured on the initial brain CT scan is independently associated with ICU mortality rate (when ≥ 7.3 mm) in severe TBI patients. See related commentary by Masquère et al., http://ccforum.com/content/17/3/151