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Objectives: To compare the overall diagnostic outcomes of 3D-CBCT sialography and ultrasonography (US) in the detection of sialolithiasis, ductal dilatation, and ductal stenosis. Methods: This retrospective monocentric study compared the two imaging modalities carried out in the same patients referred for salivary symptoms of the parotid and submandibular glands. The primary endpoint was the capacity of the imaging procedure to diagnose a lesion. The secondary objectives were the detection rates according to the type of lesion, analysis of the causes of failure, and the parameters of radiation exposure and safety (for 3D-CBCT sialography). Results: Of the 236 patients who received a 3D-CBCT sialography in our institution, 157 were ultimately included in the per-protocol analysis. 3D-CBCT sialography allowed detection of ductal lesions in 113 patients versus 86 with US. The two imaging modalities yielded congruent interpretations in 104 out of 157 subjects (66.2%). Higher sensitivity and negative predictive value were observed with 3D-CBCT sialography compared with US, irrespective of the lesions studied: 0.85 vs 0.65 and 0.70 vs 0.44, respectively. Regarding the sialolithiasis, both 3D-CBCT sialography and US allowed identification of lesions with high sensitivity and negative predictive value (0.80 vs 0.75 and 0.88 vs 0.78, respectively). Conclusions: US remains the first-line examination for exploration of the salivary lesions. 3D-CBCT sialography is an alternative in case of inconclusive US, and prior to any endoscopic procedure.

Background To evaluate the ability of the oxygen reserve index (ORI) to predict the occurrence of mild hypoxemia (defined as SpO2 Methods This observational single-centre study included patients without hypoxemia (defined as SpO2/FiO2 > 214) who required ETI in the ICU. Patients were followed during preoxygenation and ETI then until hospital discharge and/or day 28. We recorded cases of mild hypoxemia, moderate (SpO2 2 Results Between January 2019 and July 2020, 56 patients were included prospectively and 51 patients were analysed. Twenty patients had mild hypoxemia between the end of preoxygenation and the end of intubation; in 10 of these patients, the decrease in SpO2 below 97% was preceded by an ORI P = 0.0141). Conclusion In non-hypoxemic patients, the 81-s [34–146] median time between the ORI decrease below 0.4 and the SpO2 decrease below 97% during apnoea may allow preventive action. A higher ORI value during preoxygenation was independently protective against hypoxemia. Whether these findings also apply to hypoxemic patients, and the clinical impact of a preoxygenation strategy based on ORI monitoring, remain to be evaluated prospectively. Trial Registration ClinicalTrial.gov, #NCT03600181.

Placental modifications observed in women with subclinical hypothyroidism (SCH) should be associated with altered fetal development in women with gestational diabetes mellitus (GDM) and worsen perinatal outcome. We aim to determine if SCH is associated with neonatal morbidity in women with GDM. A secondary analysis of data collected for a prospective population-based cohort study including all pregnant women with singleton pregnancies at diagnosis of GDM in a tertiary care university hospital. Thyroid-stimulating hormone and free thyroxine were measured at diagnosis of GDM. Perinatal outcome was compared between two groups-women with SCH and euthyroid. Neonatal morbidity was defined by at least one of the following criteria: preterm birth, macrosomia, shoulder dystocia, respiratory distress syndrome, 5-min Apgar score

Objectives Preterm labour is the leading cause of hospitalization during pregnancy. In France, it results in more than 60,000 births before 37 weeks of gestation every year. Recent studies suggest that detection of placental α-microglobulin-1 (PAMG-1) in vaginal secretions among women presenting symptoms of preterm labour with intact membranes has good predictive value for the onset of spontaneous preterm delivery within 7 days. The test is especially interesting, in that the repetition of antenatal corticosteroids for foetal lung maturation is no longer recommended in France and the effect of the initial administration is most beneficial in the 24 h to 7 days afterwards. Methods We included all studies listed in PubMed and clinicaltrials.gov with the terms “PAMG-1” and either “preterm labor” or “preterm labour”, while excluding all studies on the subject of “rupture of the membranes” from 2000 through 2017. Ten studies were thus included. Results In women who had both the PAMG-1 and foetal fibronectin test, the PAMG-1 test was statistically superior to the measurement of cervical length for positive predictive value (p Conclusions The use of PAMG-1 may make it possible to target the women at risk with a shortened cervix on ultrasound (

The aim of our study was to investigate whether prepregnancy underweight body mass index (BMI) is associated with preterm birth (PTB) and small-for-gestational age (SGA). This retrospective case-control study included 814 women with live singleton fetuses in vertex presentation that gave birth between January 2016 and November 2016 in two tertiary care hospitals. The study group (n = 407) comprised all women whose prepregnancy BMI was underweight (2) and who delivered during the study period. A control group (n = 407) was established with women whose prepregnancy BMI was normal (18.5–24.9 kg/m2) by matching age and parity. Univariate and multivariate analyses were performed to compare PTB and SGA associated with prepregnancy underweight BMI. Compared with the control group, the study group had higher rates of overall PTB (10.1% vs. 5.7%, p = 0.02), iatrogenic PTB (4.2% vs. 1.5%, p = 0.02), and SGA (22.1% vs. 11.1%, p < 0.001). In a multivariable analysis, prepregnancy underweight BMI was associated with PTB (aOR 2.32, 95% CI 1.12–4.81) and with SGA (aOR 2.38, 95% CI 1.58–3.58). In singleton pregnancies, women’s prepregnancy underweight compared with normal BMI was associated with an increase in PTB and in SGA neonates. Identifying this specific high-risk group is pragmatic and practical for all physicians, and they should be aware about perinatal outcome among underweight women.

Introduction: Treating venous leg ulcers involves replacing dressings and applying compression bandages (CB). The technique for applying these bandages set out in the best practice guidelines shows nurses how to achieve the required level of pressure. Considerable differences have been observed between these guidelines and the actual application of CB. Methodology: An observational study combining a quantitative and a qualitative component was conducted to analyze CB application and explore the elements taken into account by nurses when they perform this procedure. Results: For the 261 patients included in the study, 27% of CB were applied as described in the guidelines. The main difference was that the heel was not included in the bandage in 48% of patients. The freelance nurses interviewed reported taking patient views into account in order to encourage adherence. Discussion: The nursing knowledge identified from the nurse interviews was compared to Carper’s “Patterns of Knowing” classification. It would seem that Carper’s empirical knowledge is not the only “pattern of knowing” taken into consideration. Patient involvement in the choice of CB application technique, which could be likened to Carper’s “esthetic knowledge,” helps guide nursing practice.

Whether providing nutrition support is beneficial or deleterious during targeted temperature management (TTM) after cardiac arrest is unclear. We therefore performed a retrospective observational study to determine whether early nutrition was beneficial or deleterious during TTM.We retrospectively studied patients admitted to our intensive care unit (ICU) between 2008 and 2014 after successfully resuscitated cardiac arrest. We compared the group given nutrition within 48 hours after ICU admission (E+ group) to the group given nutrition later on or not at all (E- group).Of the 203 included patients, 143 were in the E+ group and 60 in the E- group. The E+ group had a significantly higher proportion of patients with a good 3-month neurological outcome (42.7% vs 16.7%, P0.001). The difference remained significant after adjustment on a propensity score (odds ratio, 3.47; 95% confidence interval, 1.48-8.14; P = 0.004). The cumulative energy deficit for an energy goal of 20 kcal/kg/d from admission to day 7 was significantly lower in the E+ group (3304 ± 2863 kcal vs 5017 ± 2655 kcal, P0.001). Within the E+ group, the subgroups with nutrition initiation when body temperature was36°C vs ≥36°C were not significantly different regarding the frequencies of early-onset pneumonia, ventilator-associated pneumonia, vomiting, and prokinetic drug use (all P-values0.05).Early nutrition after cardiac arrest during TTM appears safe and may be associated with better neurological outcomes. These findings warrant a randomized controlled trial to resolve the remaining issues.

Objectives:Severe hypoxemia is the most common serious adverse event during endotracheal intubation. Preoxygenation is performed routinely as a preventive measure. The relative efficacy of the various available preoxygenation devices is unclear. Here, our objective was to assess associations between

We assessed the pharmacokinetics and safety of XAV-19, a swine glyco-humanized polyclonal antibody against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), in coronavirus disease 2019 (COVID-19)-related moderate pneumonia. The objective was to evaluate the optimal dose and safety of XAV-19 during this first administration to patients with COVID-19-related moderate pneumonia. In this phase IIa trial, adults with COVID-19-related moderate pneumonia with a duration of ≤10 days were randomized to receive an infusion of XAV-19 at 0.5 mg/kg of body weight at day 1 and day 5 (group 1), 2 mg/kg at day 1 and day 5 (group 2), or 2 mg/kg at day 1 (group 3) or placebo. Eighteen patients (n = 7 for group 1, n = 1 for group 2, n = 5 for group 3, and n = 5 for placebo) were enrolled. Baseline characteristics were similar across groups; median XAV-19 serum concentrations (ranges) at the time of the maximum serum concentration of the drug (Cmax) and at day 8 were 9.1 (5.2 to 18.1) and 6.4 (2.8 to 11.9) μg/ml, 71.5 and 47.2 μg/ml, and 50.4 (29.1 to 55.0) and 20.3 (12.0 to 22.7) μg/ml for groups 1, 2, and 3, respectively (P = 0.012). The median terminal half-life (range) was estimated at 11.4 (5.5 to 13.9) days for 2 mg/kg of XAV-19 at day 1. Serum XAV-19 concentrations were above the target concentration of 10 μg/ml (2-fold the in vitro 100% inhibitory concentration [IC100]) from the end of perfusion to more than 8 days for XAV-19 at 2 mg/kg at day 1. No hypersensitivity or infusion-related reactions were reported during treatment, and there were no discontinuations for adverse events and no serious adverse events related to the study drug. A single intravenous dose of 2 mg/kg of XAV-19 demonstrated high serum concentrations, predictive of potent durable neutralizing activity with good tolerability. (This study has been registered at ClinicalTrials.gov under identifier NCT04453384.)

Background Videolaryngoscopes with an operating channel may improve the intubation success rate in critically ill patients. We aimed to compare four channelled videolaryngoscopes to the Macintosh laryngoscope used for intubation of a high-fidelity simulation mannikin, in a scenario that simulated critical illness due to acute respiratory failure. Results Of the 79 residents who participated, 54 were considered inexperienced with orotracheal intubation. Each participant used all five devices in random order. The first-pass success rate was 97.5% [95% CI 91.1–99.7] for Airtraq™, KingVision™, and Pentax AWS200™, 92.4% [95% CI 84.2–97.2] for VividTrac VT-A100™, and 70.9% [95% CI 59.6–80.6] for direct Macintosh laryngoscopy. The first-pass success rate was significantly lower with direct Macintosh laryngoscopy than with the videolaryngoscopes (p Conclusion The Airtraq™, KingVision™, and Pentax AWS200™ channelled videolaryngoscopes produced high first-pass success rates with a lower boundary of the 95% CI above 90%. A multicentre, randomised controlled clinical study comparing channelled videolaryngoscopy to direct laryngoscopy should include one of these three videolaryngoscopes.

Background: etiological investigations are not done for all adult patients with bronchiectasis because of the availability and interpretation of tests. The aim of the study was to elaborate a score to identify patients at high risk of having cystic fibrosis or primary ciliary dyskinesia (CF/PCD), which require appropriate management. Methods: diagnostic work-ups were carried out on a French monocenter cohort, and results were subjected to logistic-regression analyses to identify the independent factors associated with CF/PCD diagnosis and, thereby, elaborate a score to validate in a second cohort. Results: among 188 patients, 158 had no obvious diagnosis and were enrolled in the algorithm-construction group. In multivariate analyses, age at symptom onset (8.69 (2.10–35.99), p = 0.003), chronic ENT symptoms or diagnosed sinusitis (10.53 (1.26–87.57), p = 0.03), digestive symptoms or situs inversus (5.10 (1.23–21.14), p = 0.025), and Pseudomonas. aeruginosa and/or Staphylococcus aureus isolated from sputum (11.13 (1.34–92.21), p = 0.02) are associated with CF or PCD. Receiver operating characteristics curve analysis, using a validation group of 167 patients with bronchiectasis, confirmed the score’s performance with AUC 0.92 (95% CI: 0.84–0.98). Conclusions: a clinical score may help identify adult patients with bronchiectasis at higher risk of having CF or PCD.

Background Early nutrition management in patients receiving extracorporeal membrane oxygenation (ECMO) remains controversial. Despite its potentially beneficial effect, enteral nutrition (EN) could be associated with gastrointestinal (GI) complications. Total daily energy requirements remain difficult to achieve with ECMO support. Analysis of nutrition practices could improve nutrition management of this particular population. Methods A monocentric retrospective study of patients requiring ECMO in a cardiac surgery intensive care unit (ICU) between 2010 and 2014 with follow-up ≥6 days. Nutrition support was monitored daily until ECMO weaning. We compared patients exposed (EN group, n = 49) and unexposed (No EN group (NEN), n = 63) with EN, as well as the energy and protein intakes within 4 days after initiation of ECMO. Vital status and nosocomial infections were followed up until ICU discharge. Primary outcome was the incidence of GI intolerance and risk-factor identification. Secondary outcomes included impact of nutrition inadequacy and clinical outcome. Results A total 112 patients were analyzed, representing 969 nutrition days. Median ratio of energy and protein prescribed/required daily was 81% (58-113) and 56% (36-86), respectively. GI intolerance was experienced by 53% (26 of 49) of patients in the EN group and was only associated with ECMO duration (odds ratio, 1.14: 95% CI, 1.00-1.31; P = .05). Low-energy and protein days were not associated with clinical outcomes such as nosocomial infections. Conclusion EN is associated with almost 50% GI intolerance without clinical benefit for patients receiving ECMO. Adequacy in energy and protein amounts did not affect clinical outcome.

BACKGROUND The standardized management of anticoagulation during the cardiopulmonary bypass seems inaccurate because of patients and surgeries variability. This study evaluates if an individualized management of heparin and protamine guided by the HMS Plus system during cardiopulmonary bypass could reduce postoperative blood loss. METHODS We conducted a prospective, controlled, unblinded, single-center study. One-hundred and eighthy-eight patients operated for cardiac surgery were included. Patients were divided in ACT Plus group (standardized approach) and HMS Plus group (individualized approach). The primary outcome was blood-loss volume during the first 24 postoperative hours. The main secondary outcomes were the need for allogeneic blood transfusions and the final protamine/heparin ratio. RESULTS There was no difference between the two groups for baseline characteristics. Medium blood-loss volume in the ACT Plus group was 522±260 mL vs. 527±255 mL in the HMS Plus group (P=0.58). The final protamine/heparin ratio in the ACT Plus group was 0.94±0.1 vs. 0.58±0.1 in the HMS Plus group (P

The optimal duration of eculizumab treatment in patients with atypical hemolytic uremic syndrome (aHUS) remains poorly defined. We conducted a prospective national multicenter open-label study to assess eculizumab discontinuation in children and adults with aHUS. Fifty-five patients (including 19 children) discontinued eculizumab (mean treatment duration, 16.5 months). Twenty-eight patients (51%) had rare variants in complement genes, mostly in MCP (n = 12; 22%), CFH (n = 6; 11%), and CFI (n = 6; 10%). At eculizumab discontinuation, 17 (30%) and 4 patients (7%) had stage 3 and 4 chronic kidney disease, respectively. During follow-up, 13 patients (23%; 6 children and 7 adults) experienced aHUS relapse. In multivariable analysis, female sex and presence of a rare variant in a complement gene were associated with an increased risk of aHUS relapse, whereas requirement for dialysis during a previous episode of acute aHUS was not. In addition, increased sC5b-9 plasma level at eculizumab discontinuation was associated with a higher risk of aHUS relapse in all patients and in the subset of carriers with a complement gene rare variant, both by log-rank test and in multivariable analysis. Of the 13 relapsing patients, all of whom restarted eculizumab, 11 regained their baseline renal function and 2 had a worsening of their preexisting chronic kidney disease, including 1 patient who progressed to end-stage renal disease. A strategy of eculizumab discontinuation in aHUS patients based on complement genetics is reasonable and safe. It improves the management and quality of life of a sizeable proportion of aHUS patients while reducing the cost of treatment. This trial was registered at www.clinicaltrials.gov as #NCT02574403.

BackgroundWe assessed the pharmacokinetics and safety of XAV-19, a swine glyco-humanized polyclonal antibody against SARS-CoV-2, in COVID-19-related moderate pneumonia. In vitro, 100% neutralization activity is seen with XAV-19 concentrations above 5 μg/mL.MethodsIn this phase 2a trial, adults with COVID-19-related moderate pneumonia of ≤10 days duration were randomized to infusion of XAV-19 0.5 mg/kg at day 1 and day 5 (group 1), 2 mg/kg at day 1 and day 5 (group 2), 2 mg/kg at day 1 (group 3) or placebo.ResultsEighteen patients (n=7 for group 1, n=1 for group 2, n=5 for group 3, and n=5 for placebo) were enrolled. Baseline characteristics were similar across groups, XAV-19 serum concentrations (μg/mL, median, range) at Cmaxand at day 8 were 9.1 (5.2-18.1) and 6.4 (2.8-11.9), 71.5 and 47.2, and 50.4 (29.1-55.0) and 20.3 (12.0-22.7) for groups 1, 2 and 3, respectively (p=0.012). Terminal half-life (median, range) was estimated at 11.4 (5.5-13.9) days for 2 mg/kg of XAV-19 at day 1. Serum XAV-19 concentrations were above the target concentration of 10 μg/mL (tow fold the in vitro 100% inhibitory concentration [IC100]) from the end of perfusion to more than 8 days for XAV-19 2 mg/kg at day 1. No hypersensitivity or infusion-related reactions were reported during treatment, there was no discontinuation for adverse events and no serious adverse events related to study drug.ConclusionsSingle intravenous dose of 2 mg/kg of XAV-19 demonstrated high serum concentrations, predictive of potent durable neutralizing activity with good tolerability.Trial registrationClinicalTrials.gov Identifier:NCT04453384Main pointIn this first-in-human trial including patients with COVID-19-related pneumonia, a single 2mg/kg dose of a swine glyco-humanized polyclonal anti-SARS-CoV-2 antibody, achieved serum concentrations above the target of neutralization threshold for 8 days in all patients, with good tolerability and safety.

The aim of our study was to describe spine immobilization in a multicentric cohort of vertebral osteomyelitis (VO), and evaluate its association with neurological complications during follow-up.We prospectively included patients from 2016 to 2019 in 11 centers. Immobilization, imaging, and neurological findings were specifically analyzed during a 6-month follow-up period.250 patients were included, mostly men (67.2%, n=168). Mean age was 66.7±15 years. Diagnosis delay was 25 days. The lumbo-sacral spine was most frequently involved (56.4%). At diagnosis, 25.6% patients (n=64) had minor neurological signs and 9.2% (n=23) had major ones. Rigid bracing was prescribed for 63.5% (n=162) of patients, for a median of 6 weeks, with variability between centers (P0.001). The presence of epidural inflammation and abscess on imaging was associated with higher rates of rigid bracing prescription (OR 2.33, P=0.01). Frailness and endocarditis were negatively associated with rigid bracing prescription (OR 0.65, P0.01, and OR 0.42, P0.05, respectively). During follow up, new minor or major neurological complications occurred in respectively 9.2% (n=23) and 6.8% (n=17) of patients, with similar distribution between immobilized and non-immobilized patients.Spine immobilization prescription during VO remains heterogeneous and seems associated inflammatory lesions on imaging but negatively associated with frailness and presence of endocarditis. Neurological complications can occur despite rigid bracing. Our data suggest that in absence of any factor associated with neurological complication spine bracing might not be systematically indicated. We suggest that spine immobilization should be discussed for each patient after carefully evaluating their clinical signs and imaging findings.

BackgroundReverse transcriptase-polymerase chain reaction (RT-PCR) testing is an important tool for the diagnosis of coronavirus disease 2019 (COVID-19). However, performance concerns have recently emerged, especially about its sensitivity.. We hypothesized that clinical, biological and radiological characteristics of patients with false negative first RT-PCR testing, despite final diagnosis of COVID-19, might differ from patients with positive first RT-PCR.MethodsCase – control, multicenter study in which COVID-19 patients with negative first RT-PCR testing were matched to patients with positive first RT-PCR on age, gender and initial admission unit (ward or intensive care).ResultsBetween March 30, and June 22, 2020, 80 cases and 80 controls were included. Neither proportion of death at hospital discharge, nor duration of hospital length stay differed between “case” and “control” patients (P = 0.80 and P = 0.54, respectively). In multivariate analysis, headache (adjusted OR: 0.07 [0.01; 0.49]; P = 0.007) and fatigue/malaise (aOR: 0.16 [0.03; 0.81]; P = 0.027) were associated with lower risk of false negative, whereas platelets > 207.103.mm−3 (aOR: 3.81 [1.10; 13.16]; P = 0.034) and CRP > 79.8 mg.L−1 (aOR: 4.00 [1.21; 13.19]; P = 0.023) were associated with higher risk of false negative.InterpretationPatients with suspected COVID-19 and higher inflammatory biological signs expected higher risk of false negative RT-PCR testing. Strategy of serial RT-PCR testings must be rigorously evaluated before adoption by clinicians.

BackgroundRecent guidelines advise against prophylactic antibiotics in patients with necrotizing pancreatitis, advocating instead a step-up drainage and necrosectomy strategy with antibiotics as dictated by microbiological findings. However, prompt antibiotic therapy is recommended in patients with sepsis or septic shock, a possible presentation of infected pancreatic necrosis (IPN). Consequently, in many critically ill patients with IPN, pancreatic samples are collected only after broad-spectrum antibiotic therapy initiation. Whether this prior antibiotic exposure alters the microbiological findings is unknown. The main objective was to determine whether prior antibiotic exposure sterilized the samples collected during procedures for suspected IPN in patients admitted to the intensive care unit (ICU) for acute pancreatitis with suspected IPN. We retrospectively studied 56 consecutive ICU patients admitted with suspected IPN. We collected details on the microbiological samples and antimicrobials used. A definite diagnosis of IPN was given when bacteria were identified in pancreatic samples.ResultsIn all, 137 pancreatic samples were collected, including 91 (66.4%) after antibiotic therapy initiation. IPN was confirmed in 48 (86%) patients. The proportion of positive samples was 74 (81.3%) in antibiotic-exposed patients and 32/46 (69.5%) in unexposed patients (p = 0.58). Of the 74 positive samples from exposed patients, 62 (84%) had organisms susceptible to the antibiotics used. One-third of samples contained more than one organism. Among patients with IPN, 37.5% had positive blood cultures. Multidrug- or extensively drug-resistant bacteria were identified at some point in half the patients.Enterobacter cloacaecomplex was more frequent in the exposed group (p = 0.02), as were Gram-negative anaerobic bacteria (p = 0.03).ConclusionAntibiotic exposure before sampling did not seem to affect culture positivity of pancreatic samples to confirm IPN, but may affect microbiological findings. Our results suggest that, in patients with sepsis and suspected IPN, antibiotics should be started immediately and pancreatic samples obtained as soon as possible thereafter. In other situations, antibiotics can be withheld until the microbiological results of pancreatic samples are available, to ensure accurate targeting of the spectrum to bacterial susceptibility patterns.ClinicalTrials.gov numberNCT03253861

Background Perineal pain due to episiotomy is commonly reported and can be severe enough to disturb the mother-infant dyad during the postpartum period. Its incidence at day 7 postpartum varies from 63% to 74%. Recent studies have already investigated the analgesic efficacy of perineal infiltration of ropivacaine after episiotomy, but have only focused on the immediate postpartum period (at 24 and 48 hours after birth). Large, adequately powered, multicenter, randomized controlled trials are required to evaluate the impact of ropivacaine infiltration on perineal pain and mid- and long-term quality of life before the widespread use of ropivacaine to prevent perineal pain after episiotomy can be recommended. Methods The ROPISIO study is a two-center, randomized, double-blind, placebo-controlled trial in La Roche sur Yon and Nantes, France. It will involve 272 women with vaginal singleton delivery and mediolateral episiotomy at term (≥ 37 weeks). Perineal infiltration (ropivacaine 75mg or placebo) will be administrated just after vaginal birth and before episiotomy repair. The primary outcome will be the analgesic efficacy at day 7 postpartum (mid-term), defined by the numerical rating scale of pain (ENS NRS) strictly superior to 3/10 on the perineal repair area. Secondary outcomes will be the analgesic efficacy (ENS NRS), the impact of pain on daily behavior, on the quality of life (36-Item Short Form Health Survey), on the occurrence of symptoms of postpartum depression (Edinburgh Postnatal Depression Scale) and on sexuality (Female Sexual Function Index) at 3 and 6 months (long-term) using validated online questionnaires. This study will have 90% power to show approximately 30% relative risk reduction in the incidence of perineal pain at day 7, from 70.0% to 50.0%. Discussion Ropivacaine is a promising candidate drug, inexpensive, easy to administer, and would be suitable to include in the routine management of deliveries in labor ward. This study will investigate if perineal ropivacaine infiltration just after birth can reduce mid- and long-term postpartum pain and increase quality of life in women with mediolateral episiotomy.

Objective To determine maternal and biological parameters at diagnosis of gestational diabetes mellitus (GDM) as predictors of antenatal insulin therapy (AIT) for glycemic control. Methods In this planned secondary analysis of a prospective observational study, we recruited women diagnosed with GDM between July 1, 2014, and October 31, 2015. Maternal and biological parameters were analyzed as predictors of AIT using multivariable logistic regression analyses. Predictive accuracy of a cut-off value for a biological predictor was determined using the area under the receiver operating characteristic curve (AUC) and the Youden index (J). Results Of 200 women included (mean gestational age 22 ± 6 weeks), 72 (36%) required AIT. No maternal characteristic was associated with AIT. Glycated hemoglobin (HbA1c; adjusted odds ratio [aOR] 3.15, 95% CI 1.03-9.69) and elevated 1-hour oral glucose tolerance test (OGTT; aOR 1.23, 95% CI 1.13-1.46) were predictors of AIT. Analyses suggested inaccurate prediction of AIT, with an optimal cut-off HbA1c value of 5.4% (J=0.14; AUC 0.58, 95% CI 0.48-0.67), and an optimal 1-hour plasma glucose OGTT value of 1.77 mg/dL (J=0.24; AUC 0.62, 95% CI 0.50-0.74). Conclusion HbA1c at diagnosis of GDM and elevated 1-hour OGTT were independent predictors of AIT for glycemic control. Clinicaltrials.gov: NCT02159378.

Editor’s Perspective What We Already Know about This Topic What This Article Tells Us That Is New Background Craniotomy for brain tumor displays significant morbidity and mortality, and no score is available to discriminate high-risk patients. Our objective was to validate a prediction score for postoperative neurosurgical complications in this setting. Methods Creation of a score in a learning cohort from a prospective specific database of 1,094 patients undergoing elective brain tumor craniotomy in one center from 2008 to 2012. The validation cohort was validated in a prospective multicenter independent cohort of 830 patients from 2013 to 2015 in six university hospitals in France. The primary outcome variable was postoperative neurologic complications requiring in–intensive care unit management (intracranial hypertension, intracranial bleeding, status epilepticus, respiratory failure, impaired consciousness, unexpected motor deficit). The least absolute shrinkage and selection operator method was used for potential risk factor selection with logistic regression. Results Severe complications occurred in 125 (11.4%) and 90 (10.8%) patients in the learning and validation cohorts, respectively. The independent risk factors for severe complications were related to the patient (Glasgow Coma Score before surgery at or below 14, history of brain tumor surgery), tumor characteristics (greatest diameter, cerebral midline shift at least 3 mm), and perioperative management (transfusion of blood products, maximum and minimal systolic arterial pressure, duration of surgery). The positive predictive value of the score at or below 3% was 12.1%, and the negative predictive value was 100% in the learning cohort. In–intensive care unit mortality was observed in eight (0.7%) and six (0.7%) patients in the learning and validation cohorts, respectively. Conclusions The validation of prediction scores is the first step toward on-demand intensive care unit admission. Further research is needed to improve the score’s performance before routine use.

Objective The primary objective of this article is to identify risk factors for infected pancreatic necrosis (IPN) in patients admitted to the intensive care unit (ICU) for severe acute pancreatitis. We also described outcomes of IPN. Background Acute pancreatitis is common and associated with multiple, potentially life-threatening complications. Over the last decade, minimally invasive procedures have been developed to treat IPN. Methods We retrospectively studied consecutive patients admitted for severe acute pancreatitis to the ICUs of the Nantes University Hospital in France, between 2012 and 2015. Logistic regression was used to evaluate potential associations linking IPN to baseline patient characteristics and outcomes. Results Of the 148 included patients, 26 (17.6%) died. IPN developed in 62 (43%) patients and consistently required radiological, endoscopic, and/or surgical intervention. By multivariate analysis, factors associated with IPN were number of organ failure (OF) (for ≥ 3: OR, 28.67 (6.23-131.96), p

Background Perineal pain due to episiotomy is commonly reported and can be severe enough to disturb the mother-infant dyad during the postpartum period. Its incidence at day 7 postpartum varies from 63% to 74%. Recent studies have already showed-investigated the analgesic efficacy of perineal infiltration of ropivacaine after episiotomy, but have only focused on the immediate postpartum period (at 24 and 48 hours after birth). Large, adequately powered, multicenter, randomized controlled trials are required to evaluate the impact of ropivacaine infiltration on perineal pain and quality of life at mid- and long-term quality of life before the widespread use of ropivacaine to prevent perineal pain after episiotomy can be recommended. Methods The ROPISIO study is a two-center, randomized, double-blind, placebo-controlled trial in La Roche sur Yon and Nantes, France. It will involve 272 women with vaginal singleton delivery and mediolateral episiotomy at term (≥ 37 weeks). Perineal infiltration (ropivacaine 75mg or placebo) will be administrated just after vaginal birth and before episiotomy repair. The primary outcome will be the analgesic efficacy at day 7 postpartum (mid-term), defined by the numerical scale of pain (ENS) strictly superior to 3/10 on the perineal repair area. Secondary outcomes will be the analgesic efficacy (ENS), the impact of pain on daily behavior, on the quality of life (36-Item Short Form Health Survey), on the occurrence of symptoms of postpartum depression (Edinburgh Postnatal Depression Scale) and on sexuality (Female Sexual Function Index) at 3 and 6 months (long-term) using validated online questionnaires. This study will have 90% power to show a approximately 30% relative risk reduction in the incidence of perineal pain at day 7 from 70.0% to 50.0%. Discussion Ropivacaine was is a promising candidate drug, inexpensive, easy to administer, and easy to add on and would be suitable to include in the routine management of deliveries in labor ward. This study will investigate if perineal ropivacaine infiltration just after birth can reduce mid- and long-term postpartum pain and increase quality of life in women with mediolateral episiotomy.

Background Nonintubated chest trauma patients with fractured ribs admitted to the intensive care unit (ICU) are at risk for complications and may require invasive ventilation at some point. Effective pain control is essential. We assessed whether epidural analgesia (EA) in patients with fractured ribs who were not intubated at ICU admission decreased the need for invasive mechanical ventilation (IMV). We also looked for risk factors for IMV. Study design and methods This retrospective, observational, multicenter study conducted in 40 ICUs in France included consecutive patients with three or more fractured ribs who were not intubated at admission between July 2013 and July 2015. Results Of the 974 study patients, 788 were included in the analysis of intubation predictors. EA was used in 130 (16.5%) patients, and 65 (8.2%) patients required IMV. Factors independently associated with IMV were chronic respiratory disease (P = 0.008), worse SAPS II (P P = 0.02), worse Injury Severity Score (P = 0.0003), higher respiratory rate at admission (P = 0.02), alcohol withdrawal syndrome (P P = 0.04). EA was not associated with decreases in IMV requirements, median numerical rating scale pain score, or intravenous morphine requirements from day 1 to day 7. Conclusions EA was not associated with a lower risk of IMV in chest trauma patients with at least 3 fractured ribs, moderate pain, and no intubation on admission. Further studies are needed to clarify the optimal pain control strategy in chest trauma patients admitted to the ICU, notably those with severe pain or high opioid requirements.

Background Osimertinib, a third-generation tyrosine kinase inhibitor, is a new therapeutic option in epidermal growth factor receptor (EGFR)-mutated non-pretreated advanced non–small-cell lung cancer (NSCLC). The tumor escape mechanisms after first-line treatment with osimertinib are partially known; most of the data being obtained by analysis of circulating tumor DNA (ctDNA) from the FLAURA phase III trial. Study Design The MELROSE study, a French multicentric, open label, phase II trial ( ClinicalTrials.gov NCT03865511 ) plans to enroll 150 patients with treatment-naive advanced EGFR-mutated (L858R or exon 19 deletion) NSCLC, age ≥ 18 years, with an Eastern Cooperative Oncology Group performance status 0 or 1. All patients will receive osimertinib at the dose of 80 mg/d. Tumor assessment according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria will be performed every 3 months, with brain and thoracoabdominal computed tomographic scan. The continuation of osimertinib is at the discretion of the referring physician, particularly if clinical benefit is observed. The primary objective is the genetic tumor profile, both on tissue biopsy and ctDNA analyses, at the time of disease progression. Other endpoints include kinetic studies of ctDNA, biological progression-free survival (bPFS) (time from first study dose to first biological event on ctDNA), median PFS according to RECIST criteria 1.1 (called radiological [r] PFS), and median clinical (c) PFS (time from the first study dose to off-osimertinib). This study started in April 2019, and 18 centers in France are participants.

Introduction: Treating venous leg ulcers involves replacing dressings and applying compression bandages (CB). The technique for applying these bandages set out in the best practice guidelines shows nurses how to achieve the required level of pressure. Considerable differences have been observed between these guidelines and the actual application of CB. Methodology: An observational study combining a quantitative and a qualitative component was conducted to analyze CB application and explore the elements taken into account by nurses when they perform this procedure. Results: For the 261 patients included in the study, 27% of CB were applied as described in the guidelines. The main difference was that the heel was not included in the bandage in 48% of patients. The freelance nurses interviewed reported taking patient views into account in order to encourage adherence. Discussion: The nursing knowledge identified from the nurse interviews was compared to Carper’s “Patterns of Knowing” classification. It would seem that Carper’s empirical knowledge is not the only “pattern of knowing” taken into consideration. Patient involvement in the choice of CB application technique, which could be likened to Carper’s “esthetic knowledge,” helps guide nursing practice.

International audience; Purpose: To report the incidence, risk factors, clinical presentation, and outcome predictors of severe leptospirosis requiring intensive care unit (ICU) admission in a temperate zone.Methods: LEPTOREA was a retrospective multicentre study conducted in 79 ICUs in metropolitan France. Consecutive adults admitted to the ICU for proven severe leptospirosis from January 2012 to September 2016 were included. Multiple correspondence analysis (MCA) and hierarchical classification on principal components (HCPC) were performed to distinguish different clinical phenotypes.Results: The 160 included patients (0.04% of all ICU admissions) had median values of 54 years [38-65] for age, 40 [28-58] for the SAPSII, and 11 [8-14] for the SOFA score. Hospital mortality was 9% and was associated with older age; worse SOFA score and early need for endotracheal ventilation and/or renal replacement therapy; chronic alcohol abuse and worse hepatic dysfunction; confusion; and higher leucocyte count. Four phenotypes were identified: moderately severe leptospirosis (n = 34, 21%) with less organ failure and better outcomes; hepato-renal leptospirosis (n = 101, 63%) with prominent liver and kidney dysfunction; neurological leptospirosis (n = 8, 5%) with the most severe organ failures and highest mortality; and respiratory leptospirosis (n = 17, 11%) with pulmonary haemorrhage. The main risk factors for leptospirosis contamination were contact with animals, contact with river or lake water, and specific occupations.Conclusions: Severe leptospirosis was an uncommon reason for ICU admission in metropolitan France and carried a lower mortality rate than expected based on the high severity and organ-failure scores. The identification in our population of several clinical presentations may help clinicians establish an appropriate index of suspicion for severe leptospirosis.

Background Threatened preterm delivery (TPD) is the leading cause of inpatient admissions during pregnancy. The ability to predict the risk of imminent preterm delivery is thus a major priority in obstetrics. The aim of our study is to assess the diagnostic performance of the test to detect the placental alpha microglobulin 1 (PAMG-1) for the prediction of delivery within 7 days in women with TPD. Methods This is a prospective multicenter diagnostic study. Inclusion criteria are singleton pregnancy, gestational age between 24 + 0 and 33 + 6 weeks inclusive, cervical measurement 25 mm or less assessed by transvaginal ultrasound (with or without uterine contractions), clinically intact membranes and cervical dilatation According to the current protocol, when a women presents with TPD and the diagnosis is confirmed by transvaginal ultrasound, a vaginal sample to test for genital infection is performed. At the same time, the midwife will perform the PartoSure® test. To perform this analysis, a sample of cervicovaginal secretions is taken with the vaginal swab furnished in the test kit. The primary outcome is the specificity of the PartoSure® test of women who gave birth more than 7 days after their hospitalization for TPD. The secondary outcomes are the sensitivity, PPV, and NPV of the Partosure® test and the factors associated with false positives (with a univariate logistic regression model). Starting with the hypothesis of an anticipated specificity of 89%, if we want to estimate this specificity with a confidence interval of ± 5%, we will require 151 women who do not give birth within 7 days. We therefore decided to include 400 women over a period of two years to have a larger number of events (deliveries within 7 days). Discussion The different tests already used such as fetal fibronectin and phIGFBP-1, are not sufficiently relevant to recommend their use in daily practice. The different studies of PAMG-1 described above thus provide support for the use of this substance, tested by PartoSure®. Nonetheless, other larger studies are necessary to validate its use in daily practice and our study could answer this question. Trial registration NCT03401255 (January 15, 2018)

To validate the modified Pregnancy-Unique Quantification of Emesis and Nausea (PUQE) score and the Health-Related Quality of Life for Nausea and Vomiting of Pregnancy (NVP-QOL) score in a French population.A retrospective study was conducted of data for women who delivered at a tertiary care hospital in La Roche sur Yon, France, between November 1, 2012, and April 1, 2013. Only women who reported nausea and vomiting of pregnancy (NVP) in the first trimester were invited to respond to the two questionnaires.Overall, complete questionnaires were available from 399 women, 238 (59.6%) of whom reported NVP in the first trimester. The modified-PUQE score was associated with the self-reported symptom severity (P0.001). A relationship was also noted when either the NVP-QOL score or the modified-PUQE score was compared with the symptom intensity (P0.001 for both comparisons). Furthermore, a high NVP-QOL score was associated with a high modified-PUQE score (P0.001).The modified-PUQE and NVP-QOL scores provided valid indices for assessing NVP severity and alterations in quality of life. Owing to its simplicity, the modified-PUQE score might be used routinely among women experiencing NVP in the first trimester of pregnancy.

IntroductionOsteoarthritis of the trapeziometacarpal joint affects approximately 10%–25% of women, especially those who are postmenopausal. It may result in thumb dysfunction. Among the treatments, intra-articular injections of corticosteroid (CS) and hyaluronic acid (HA) are both effective and recommended. However, clinical trials have shown that HA improves functional capacity, whereas CS only produces a decrease in pain. The synergy of these two drugs has not been evaluated. The primary goal of this study was to determine whether the association between HA and CS produce an additional decrease of more pain during thumb movement at three months postinjection, compared to the level of pain relief from CS alone.Methods and analysisRHIZ’ART is a prospective, multicentre, comparative, randomised, controlled, double-blind trial. Patients referred to the rheumatology department for thumb rhizarthrosis will receive an injection of betamethasone with HA or placebo (serum saline) based on central randomisation and stratification by centre. Injections will be given under ultrasound guidance. The primary outcome will compare the pain Visual Analogue Scale with motion at three months for both groups using a mixed model. The expected decrease in pain intensity in the CS group is 25% and 35% in the CS with HA group. In order to achieve a 80% power for detecting this difference with α set at 5%, 73 patients are needed in each group (146 total). The main secondary outcomes are the Cochin score (hand function) and grip strength. Follow-up visits are at 1, 3, 6 and 12 months.Ethics and disseminationThe study project has been approved by the appropriate ethics committee (CPP île de France III, 2017-002298-20). In agreement with current French regulations, a signed informed written consent will be obtained from each patient. Results of the main trial and of the secondary endpoints will be submitted for publication in a peer-reviewed journal.Trial registration numberNCT03431584.

Background: Presumed benign ovarian tumours (PBOT) are defined by the International Ovarian Tumour Analysis (IOTA) group, without suspected sonographic criteria of cancer, without ascites or metastasis. The aim is to evaluate the efficacy of human epididymis protein 4 (HE4), cancer antigen 125 (CA125), the risk of malignancy index (RMI) and the risk of ovarian malignancy index (ROMA) to predict ovarian cancer in women with PBOT. Methods: It is a prospective, observational, multicentre, laboratory-based study including women with PBOT in four hospitals from 11 May 2015 through 12 May 2016. Preoperative CA125 and HE4 plasma levels were measured for all women. The primary endpoint was the specificity of CA125 and HE4 for diagnosing ovarian cancer. The main secondary endpoints were specificity and likelihood ratio of RMI, ROMA and tumours markers. Results: Two hundred and fifty patients were initially enrolled and 221 patients were finally analysed, including 209 benign ovarian tumours (94.6%) and 12 malignant ovarian tumours (5.4%). The malignant group had significantly higher mean values of HE4, CA125, RMI and ROMA compared to the benign group (p &lt, 0.001). Specificity was significantly higher using a combination of HE4 and CA125 (99.5%) compared to either HE4 or CA125 alone (90.4% and 91.4%, respectively, p &lt, 0.001). Moreover, the positive likelihood ratio for combination HE4 and CA125 was significantly higher (104.5, 95% CI 13.6&ndash, 800.0) compared to HE4 alone (5.81, 95% CI 2.83&ndash, 11.90) or CA125 alone (6.97, 95% CI 3.91&ndash, 12.41). Conclusions: The combination of HE4 and CA125 represents the best tool to predict the risk of ovarian cancer in patients with a PBOT.