Eaubonne

Small Bowel Obstruction (SBO) is a frequent pathology, leading to admissions to emergency departments (ED). Diagnosis is currently based on an abdominal CT scan (CT). However, CT is associated with drawbacks such as radiation exposure, increased cost and ED length-of-stay. A recent meta-analysis including 1178 patients showed that Point of care ultrasound (POCUS) had a good diagnostic accuracy (sensitivity 83% \[95%CI 71.7%-90.4%\]), specificity 93% \[95%CI 55.3% -99.3%\]). Another meta-analysis with 433 patients, found rather similar results: sensitivity 83% \[95% CI 89.0% to 94.7%\], specificity 96,6% \[95% CI 88.4% to 99.1%\]). Since CT is almost warranted to guide the treatment strategy, which could include surgery, medical treatment or both, CHU of Nantes emergency unit explored a different approach focusing on POCUS rule-out ability. This study also introduced the notion of SBO Gestalt probability which is a global clinical evaluation by the physician. Gestalt probability has mainly been explored in patients with suspected pulmonary embolism and was found as effective as clinical prediction rules. It is used in the routine clinical evaluation of patient with suspicion of pulmonary embolism. When applied to patients with SBO suspicion, the physician chooses between low, moderate or high risk of SBO. Based on CT results, prevalence of SBO based on Gestalt probability were 21%, 45% and 87% in the low, moderate and high risks, respectively. Our team studied POCUS with the following items that were searched in the whole abdomen divided into nine zones: dilated incompressible fluid-filled intestinal loop (\>25 mm) with back-and-forth fluid movement. When at least one of these signs was present in one zone, the SBO was highly suspected. As it was an observational study, a CT was performed in all patients and was the gold standard. This approach was associated with a POCUS sensitivity in the whole population of 99% \[95% CI: 93-99.8\] \[2\]. POCUS would thus have a role in patients with low and moderate SBO risks because the prevalence of SBO was major in the high risk Gestalt probability category of patients, and thus CT is the only imaging needed in these latter. Furthermore, in patients with low or moderate probability, the sensitivity was 100% \[95% CI: 88-100\] In previous studies, the sensitivity was not able to exclude SBO with sufficient security since the lower 95% confidence interval margin was near 90%. By (i) focusing on patients with a low or moderate clinical Gestalt probability and (ii) increasing the number of patients, CHU of Nantes emergency unit intends to demonstrate that POCUS should be able to safely exclude SBO in this population. In case of positive results, the diagnostic strategy in case of SBO suspicion could be modified in: firstly, assess the clinical Gestalt probability; secondly perform a POCUS in patients with low or moderate Gestalt probability and thirdly, prescribe a CT only for patients with high clinical probability or presence of POCUS signs of SBO. This would avoid unnecessary CT and thus lower patient's. exposure, costs, ED length-of-stay and radiologist workload. A study performed in the USA simulated a POCUS first approach in patients with suspected SBO and found that it could save ED length of stay, radiation and money. In France in 2017, about ¾ of ED were equipped with ultrasound machines and half of the emergency physicians were trained in POCUS. Furthermore, SBO detection is easily performed: in our study, the operator self-assessed ultrasound experience was beginner or intermediate for 59% of patients. In case of positive results, this technique would be largely deployed. Inclusion criteria will be patients with low or moderate Gestalt clinical probability of SBO. A POCUS will be performed followed by a CT (gold standard). This CT will be realized and interpreted blindly from the POCUS results. The main objective will be the ability of POCUS to rule-out SBO in patients with low or moderate Gestalt clinical probability

The investigators aim to assess the feasibility and accuracy of a new pragmatic and original ultrasound algorithm adapted for acute dyspnea diagnosis in the emergency department. This primary objective of this prospective multicenter study is to assess the diagnostic accuracy of an ultrasound algorithm (EMERALD-US) dedicated to emergencies using lung, cardiac and vascular ultrasound for the 3 main dyspnea causes (heart failure, pneumonia and obstructive pulmonary disease exacerbation) in patients with acute non-traumatic dyspnea managed in the emergency department. Ultrasound exams will be blindly read by a centralized core laboratory after the standardized acquisition of all exams by a physician not involved in the care of patients in the ED. The main discharge diagnosis from initial hospitalization (heart failure, pneumonia and obstructive pulmonary disease exacerbation) will be adjudicated by a college of 3 senior physicians (emergency physician, cardiologist and internist) blinded to the use of ultrasound in the ED. The secondary objectives of the study are to: A/ Assess the feasibility of the ultrasound algorithm (EMERALD-US) in emergency departments. B/ Assess the association between the diagnosis obtained from the ultrasound algorithm (EMERALD-US) and the results of additional (laboratory and radiological exams. C/ Assess the diagnostic accuracy of the ultrasound algorithm (EMERALD-US) for less frequent dyspnea causes (pulmonary embolism, pleural effusion). D/ Assess, the diagnostic accuracy of clinical (including BREST and PREDICA score), laboratory and radiological variables. E/ Assess, the improvement in diagnosis accuracy with the ultrasound algorithm (EMERALD-US) on top of the diagnostic accuracy of clinical, laboratory and radiological exams. F/ Assess the association between misdiagnosis (without using ultrasound) and survival at D30.

The study is designed to address the specific requirements from National Commission for the Evaluation of Medical Devices and Health Technologies (CNEDiMTS) and to complete data obtained up to now, with a larger cohort and in real life settings. In order to increase variability in the profiles of patients included and to be as representative as possible of all eligible patients, 20 centers will participate in the study, both private and public, with a mix of university and regional centers and 348 patients will be included consecutively. The inclusion period lasts 6 months and each patient will be included in the study for a period of 2 weeks of run-in and 1 year of treatment. An inclusion period of 6 months is enough according to investigation site data and estimation of inclusion over 6 months (detailed in part Healthcare professional and investigation centers recruitment). This study is observational. Patients included follow their usual medical care and will only be asked for the specific need of the study to answer two questionnaires (at the beginning and at the end of the study) and give their HbA1c results performed in their current medical follow-up. As it is a post-registration study, medical devices are provided to patients on medical prescription by healthcare providers, which have signed a distribution agreement with and have been trained by Diabeloop. Patients have their system for 4 a maximum of 4 years (life duration of the medical device (DBLG1 System)). Patients follow-up visits are not mandatory and no frequency is imposed. Investigators, according to their habits, have follow-up visits corresponding to what they usually propose to patients having a new treatment. During the whole study and apart from scheduled visits (inclusion, beginning of run-in, beginning of treatment , enf of study), each patient may contact his/her clinician investigator in case of issue he/she judges as serious, for questions, etc. In that case, the clinician may program a visit with the patient and deal with adverse events. Phone calls are recorded in Case Report Form (CRF), as well as on-site visits. Note: with Yourloops; investigators may follow the state of their patients, regarding the time in range, mean glycemia value etc. Based on this, they may require a visit at their convenience with the patient in order to change parameters of the system, discuss adverse events, etc. Objectives are the following To evaluate improvement in blood glucose control with use of DBLG1 System after one year in real life. To evaluate details of glycemic control improvement, safety and adverse events due to the DBLG1 System, evolution of quality of life after one year in real life and healthcare professional support. Study endpoints Improvement of the time in glycemic range 70 - 180 mg/dL, in percentage, on 24hours and nighttime. HbA1c Mean CGM glucose - on 24hours and nighttime Time in 70 - 140 mg/dL range on 24hours and nighttime only Time in hypoglycemia (under 70 mg/dL, 60 mg/dL and 50 mg/dL) - on 24hours and nighttime Time in hyperglycemia (above 180 mg/dL, 250 mg/dL and 300 mg/dL) - on 24hours and nighttime Percentage of time using activated loop mode vs. deactivated loop mode Standard Deviation (SD) and Coefficient of variation (CV) of Continuous Glucose Monitoring (CGM) values on 24hours and nighttime Number and type of adverse events Overall and diabetic-specific quality of life Quantification of the healthcare professional support required An descriptive interim analysis will be made on the first 100 enrolled patients after 6 months of use of the DBLG1.

Several studies have reported positive impact of some interventions on the tracheal intubation-related complications incidence. Providing bag face-mask ventilation between medication administration and initiation of laryngoscopy significantly reduced the number of peri intubation hypoxemia episodes. The use of a non-depolarizing (rocuronium) paralytic agent instead of succinylcholine is associated with less post-intubation complications occurrence. Finally, use of a tracheal tube introducer (GEB) as an aid for intubation in emergency patients with at least one prognostic factor of difficult laryngoscopy has been shown to facilitate intubation. Assessment of a strategy combining these three interventions to reduce intubation related morbidity in emergency situations has never been assessed. It is expected that the combination of these interventions will drastically reduce the morbidity associated with emergency intubation. The strategy assessed will associate rocuronium use as paralyzing agent to facilitate intubation, bag mask ventilation before intubation and GEB use at first intubation attempt in all patients. The emergency physician in charge of the patients will record out-of hospital outcomes immediately after the out-of-hospital period. Intra-hospital data will be retrieved from the patient's medical record on the 28th day after inclusion.

Community-acquired pneumonia (CAP) that is of sufficient severity to require admission to an intensive care unit (ICU) is associated with substantial mortality. Patients with pneumonia who are being treated in an ICU will receive therapy that consists of many different treatments, as many as 20 or 30. These treatments act together to treat both the infection and its effects on the body. When treating a patient, doctors choose from many different treatments, most of which are known or believed to be safe and effective. However, doctors don't always know which treatment option is the better one, as individuals or groups of individuals may respond differently. This study aims to help doctors understand which treatments work best. This clinical study has been designed in a way that allows the information from patients already in the study to help new patients joining the study. Most studies aren't able to do that. REMAP-CAP has been designed to: * Evaluate multiple treatment strategies, at the same time, in the same patient. * Reach platform conclusions when sufficient data is accrued, rather than when a pre-specified sample size is reached * Utilise data that is already accrued to increase the likelihood that patients within the trial are randomised to treatments that are more likely to be beneficial * New questions can be substituted into the trial as initial questions are answered, meaning that the trial can be perpetual or open-ended * Interactions between interventions in different domains can be evaluated It is reasonable to presume that any pandemic respiratory infection of major significance to public health will manifest as life-threatening respiratory infection including Severe Acute Respiratory illness and severe Community Acquired Pneumonia (CAP) with concomitant admission to hospital, and for some patients, admission to an Intensive Care Unit (ICU). Previous pandemics and more localized outbreaks of respiratory emerging infections have resulted in severe CAP and ICU admission. Previous pandemics and outbreaks of emerging infectious diseases have outlined the urgent need for evidence, preferably from Randomized Controlled Trials (RCTs), to guide best treatment. However, there are substantial challenges associated with being able to organize such trials when the time of onset of a pandemic and its exact nature are unpredictable. As an adaptive platform trial that enrolls patients during the interpandemic period, REMAP-CAP is ideally positioned to adapt, in the event of a respiratory pandemic, to evaluate existing treatments as well as novel approaches.

Lower limb trauma requiring immobilization is a very frequent condition that is associated with an increased risk of developing venous thromboembolism (VTE). The TRiP(cast) score has been developed to provide individual VTE risk stratification and help in thromboprophylactic anticoagulation decision. The recent CASTING study had confirmed that patients with a TRiP(cast) score \<7 have a very low risk of VTE and could be safely manage without prophylactic treatment. Conversely, patients with a score ≥ 7 have a high-risk of VTE and require a prophylactic anticoagulant treatment. Low molecular weight heparins (LMWH) have been shown to be effective in this indication. However, in the CASTING study, the 3-month symptomatic VTE rate was 2.6% in this subgroup despite LMWH prophylactic treatment. This result suggests that LMWH are not sufficiently effective in this particular subgroup of high-risk patients. Direct oral anticoagulants, and in particular rivaroxaban, may be an effective and safe alternative to LMWH. In the PRONOMOS study, comparing LMWH with rivaroxaban in patients who had undergone non-major lower limb surgery, the relative risk of symptomatic VTE was 0.25 (95% CI = 0.09 - 0.75) in favor of rivaroxaban 10mg. No significant increase in bleeding was found. In addition, as LMWH treatment requires subcutaneous daily injections, the use of rivaroxaban may positively impact patients' quality of life as well as being effective in medico-economic terms. The aims of this study are to demonstrate that rivaroxaban is at least as effective, easier to use and more efficient than LMWH in patients with trauma to the lower limb requiring immobilisation and deemed to be at risk of venous thromboembolism (TRiP(cast) score ≥ 7). High-risk patients are randomized to receive either rivaroxaban or LMWH. They are followed up at 45 days and 90 days to assess the occurrence of thrombotic events or bleeding, as well as their satisfaction with the treatment received.

Method and Material: Couples included in the prospective multi-center observational PhysioCare study (3 centers ; exposed/unexposed,1:2 ratio (1 woman in AMU for 2 in SOU), matched by center and parity) will be invited to complete standardized questionnaires online 2 years after birth: City Birth Trauma Scale, Edinburgh Postnatal Depression Scale, generic SF-12 questionnaire, Mother-to-Infant Bonding scale, Questionnaire d'Auto-Evaluation de la Compétence Educative Parentale, Multidimensional Scale of Perceived Social Support, Child Development Inventory (short version), data on breastfeeding and health. Estimated sample size at 2 years (with 70% of respondents): 420 women; 328 coparents. Semi-structured interviews to assess women's, partners' and professionals' perceptions of care will be conducted on a sample of couples. Multivariate intention-to-treat statistical analyses (linear/logistic regression with propensity score, IPTW) will be performed. Findings expected : PhysioCareTwo study has the potential to produce significant results that improve maternal and child health, strengthen medical practices, and promote family well-being. These spin-offs can have a positive impact in the short, medium and long term in the perinatal field. Conclusion : To generate concrete knowledge for the benefit of parents and their children, improve perinatal care in France, and promote these care approach.