Simple Aspiration versus Drainage for Complete Pneumothorax: A Randomized Noninferiority Trial.

Rationale: Management of first episodes of primary spontaneous pneumothorax remains the subject of debate. Objectives: To determine whether first-line simple aspiration is noninferior to first-line chest tube drainage for lung expansion in patients with complete primary spontaneous pneumothorax. Methods: We conducted a prospective, open-label, randomized noninferiority trial. Adults aged 18-50 years with complete primary spontaneous pneumothorax (total separation of the lung from the chest wall), recruited at 31 French hospitals from 2009 to 2015, received simple aspiration (n = 200) or chest tube drainage (n = 202) as first-line treatment. The primary outcome was pulmonary expansion 24 hours after the procedure. Secondary outcomes were tolerance of treatment, occurrence of adverse events, and recurrence of pneumothorax within 1 year. Substantial discordance in the numerical inputs used for trial planning and the actual trial rates of the primary outcome resulted in a reevaluation of the trial analysis plan. Measurement and Main Results: Treatment failure occurred in 29% in the aspiration group and 18% in the chest tube drainage group (difference in failure rate, 0.113; 95% confidence interval [CI], 0.026-0.200). The aspiration group experienced less pain overall (mean difference, -1.4; 95% CI, -1.89, -0.91), less pain limiting breathing (frequency difference, -0.18; 95% CI, -0.27, -0.09), and less kinking of the device (frequency difference, -0.05; 95% CI, -0.09, -0.01). Recurrence of pneumothorax was 20% in this group versus 27% in the drainage group (frequency difference, -0.07; 95% CI, -0.16, +0.02). Conclusions: First-line management of complete primary spontaneous pneumothorax with simple aspiration had a higher failure rate than chest tube drainage but was better tolerated with fewer adverse events. Clinical trial registered with www.clinicaltrials.gov (NCT01008228).

Multicentre cross-sectional observational registry to monitor the safety of early discharge after rule-out of acute myocardial infarction by copeptin and troponin: the Pro-Core registry.

OBJECTIVES: There is sparse information on the safety of early primary discharge from the emergency department (ED) after rule-out of myocardial infarction in suspected acute coronary syndrome (ACS). This prospective registry aimed to confirm randomised study results in patients at low-to-intermediate risk, with a broader spectrum of symptoms, across different institutional standards and with a range of local troponin assays including high-sensitivity cTn (hs-cTn), cardiac troponin (cTn) and point-of-care troponin (POC Tn). DESIGN: Prospective, multicentre European registry. SETTING: 18 emergency departments in nine European countries (Germany, Austria, Switzerland, France, Spain, UK, Turkey, Lithuania and Hungary) PARTICIPANTS: The final study cohort consisted of 2294 patients (57.2% males, median age 57 years) with suspected ACS. INTERVENTIONS: Using the new dual markers strategy, 1477 patients were eligible for direct discharge, which was realised in 974 (42.5%) of patients. MAIN OUTCOME MEASURES: The primary endpoint was all-cause mortality at 30 days. RESULTS: Compared with conventional workup after dual marker measurement, the median length of ED stay was 60 min shorter (228 min, 95% CI: 219 to 239 min vs 288 min, 95% CI: 279 to 300 min) in the primary dual marker strategy (DMS) discharge group. All-cause mortality was 0.1% (95% CI: 0% to 0.6%) in the primary DMS discharge group versus 1.1% (95% CI: 0.6% to 1.8%) in the conventional workup group after dual marker measurement. Conventional workup instead of discharge despite negative DMS biomarkers was observed in 503 patients (21.9%) and associated with higher prevalence of ACS (17.1% vs 0.9%, p<0.001), cardiac diagnoses (55.2% vs 23.5%, p<0.001) and risk factors (p<0.01), but with a similar all-cause mortality of 0.2% (95% CI: 0% to 1.1%) versus primary DMS discharge (p=0.64). CONCLUSIONS: Copeptin on top of cardiac troponin supports safe discharge in patients with chest pain or other symptoms suggestive of ACS under routine conditions with the use of a broad spectrum of local standard POC, conventional and high-sensitivity troponin assays. TRIAL REGISTRATION NUMBER: NCT02490969.

Chest trauma: First 48hours management.

Chest trauma remains an issue for health services for both severe and apparently mild trauma management. Severe chest trauma is associated with high mortality and is considered liable for 25% of mortality in multiple traumas. Moreover, mild trauma is also associated with significant morbidity especially in patients with preexisting conditions. Thus, whatever the severity, a fast-acting strategy must be organized. At this time, there are no guidelines available from scientific societies. These expert recommendations aim to establish guidelines for chest trauma management in both prehospital an in hospital settings, for the first 48hours. The "Société française d'anesthésie réanimation" and the "Société française de médecine d'urgence" worked together on the 7 following questions: (1) criteria defining severity and for appropriate hospital referral; (2) diagnosis strategy in both pre- and in-hospital settings; (3) indications and guidelines for ventilatory support; (4) management of analgesia; (5) indications and guidelines for chest tube placement; (6) surgical and endovascular repair indications in blunt chest trauma; (7) definition, medical and surgical specificity of penetrating chest trauma. For each question, prespecified "crucial" (and sometimes also "important") outcomes were identified by the panel of experts because it mattered for patients. We rated evidence across studies for these specific clinical outcomes. After a systematic Grade® approach, we defined 60 recommendations. Each recommendation has been evaluated by all the experts according to the DELPHI method.

Multifaceted Intervention to Prevent Venous Thromboembolism in Patients Hospitalized for Acute Medical Illness: A Multicenter Cluster-Randomized Trial.

BACKGROUND: Misuse of thromboprophylaxis may increase preventable complications for hospitalized medical patients. OBJECTIVES: To assess the net clinical benefit of a multifaceted intervention in emergency wards (educational lectures, posters, pocket cards, computerized clinical decision support systems and, where feasible, electronic reminders) for the prevention of venous thromboembolism. PATIENTS/METHODS: Prospective cluster-randomized trial in 27 hospitals. After a pre-intervention period, centers were randomized as either intervention (n = 13) or control (n = 14). All patients over 40 years old, admitted to the emergency room, and hospitalized in a medical ward were included, totaling 1,402 (712 intervention and 690 control) and 15,351 (8,359 intervention and 6,992 control) in the pre-intervention and intervention periods, respectively. RESULTS: Symptomatic venous thromboembolism or major bleeding (primary outcome) occurred at 3 months in 3.1% and 3.2% of patients in the intervention and control groups, respectively (adjusted odds ratio: 1.02 [95% confidence interval: 0.78-1.34]). The rates of thromboembolism (1.9% vs. 1.9%), major bleedings (1.2% vs. 1.3%), and mortality (11.3% vs. 11.1%) did not differ between the groups. Between the pre-intervention and intervention periods, the proportion of patients who received prophylactic anticoagulant treatment more steeply increased in the intervention group (from 35.0% to 48.2%: +13.2%) than the control (40.7% to 44.1%: +3.4%), while the rate of adequate thromboprophylaxis remained stable in both groups (52.4% to 50.9%: -1.5%; 49.1% to 48.8%: -0.3%). CONCLUSIONS: Our intervention neither improved adequate prophylaxis nor reduced the rates of clinical events. New strategies are required to improve thromboembolism prevention for hospitalized medical patients. TRIAL REGISTRATION: ClinicalTrials.gov NCT01212393.

Analysis of Inappropriate Admissions of Residents of Medicalized Nursing Homes to Emergency Departments: A Prospective Multicenter Study in Burgundy.

OBJECTIVES: To determine the rate of inappropriate admissions to emergency departments (EDs) and to identify determinants of these admissions. DESIGN: Prospective multicenter study. SETTING: Burgundy (France), EDs and medical nursing homes (MNHs). PARTICIPANTS: 1000 Burgundy MNH residents admitted to EDs, from April 17 to June 20, 2013. MEASUREMENTS: For each subject, a questionnaire was completed. Data included age, gender, type of health professional who referred the resident to the ED (THP), whether or not a medical dispatcher organized the transfer to the ED, transport mode, reason for admission to the ED, level of independence according to the Groupes Iso-Ressource score (GIRS), and diagnosis made in the ED. The French version of the Appropriateness Evaluation Protocol grid was applied to each admission to the ED, and in some situations, the expert committee ruled on the appropriateness of the admission to the ED. MNH characteristics were also recorded. Two groups were constituted according to the appropriateness or not of admission to the ED. RESULTS: Mean age of the 1000 residents was 87. There were 706 women. Two-thirds were referred to the EDs by a physician, mainly a general practitioner. In 91.7%, the transfer to the ED was organized by a medical dispatcher, and 8.8% were transported by medicalized transport. More than 95% had a GIRS ≤4. Among the admissions to EDs, 18.1% were inappropriate. Female gender (P = .017), nonmedicalized transport (P = .002), public MNH (P = .044), and nonaccess to a geriatric opinion in an emergency (P = .043) were determinants of inappropriate admission to EDs. CONCLUSION: In this first study on admissions to EDs of MNH residents using French data, we found a lower rate of admissions to the ED than that reported in the literature. Female gender, nonmedicalized transport, public MNH, and nonaccess to a geriatric opinion in an emergency were associated with inappropriate admission to EDs.

[If I had a stroke in 2015]. / Si j'avais un accident vasculaire cérébral aigu en 2015.

The management of stroke is now recognized as a real medical emergency as well as myocardial infarct, because we have now an efficacious treatment in cerebral infarct, intravenous fibrinolysis that decreases the risk of death and motor and cognitive handicap. The second characteristic is its very important frequency, and its risk that increases in young people. This medical emergency enforces the care systems because it needs a speedy network for the patient, his family and the care professionals, useful for intravenous fibrinolysis before 3 hours after 80 years and before 4 hours and a half before 80 years. It is necessary to start treatment as soon as possible because it is most effective when given early. The consequences to avoid the lost of chance, need several actions: inform the public about the interest of FAST score to identify the first signs (facial palsy, palsy of arm, aphasia and time of stroke onset); call 15; translate the patient towards an appropriate medical center; use tele-stroke when the hospital has no neurologist; and manage the patient in a stroke unit, to introduce in a second time secondary prevention thanks to therapeutical education. Therefore, stroke care is a real multiprofessional emergency around the neurologist.

A French multicenter randomised trial comparing two dose-regimens of prothrombin complex concentrates in urgent anticoagulation reversal.

INTRODUCTION: Prothrombin complex concentrates (PCC) are haemostatic blood preparations indicated for urgent anticoagulation reversal, though the optimal dose for effective reversal is still under debate. The latest generation of PCCs include four coagulation factors, the so-called 4-factor PCC. The aim of this study was to compare the efficacy and safety of two doses, 25 and 40 IU/kg, of 4-factor PCC in vitamin K antagonist (VKA) associated intracranial haemorrhage. METHODS: We performed a phase III, prospective, randomised, open-label study including patients with objectively diagnosed VKA-associated intracranial haemorrhage between November 2008 and April 2011 in 22 centres in France. Patients were randomised to receive 25 or 40 IU/kg of 4-factor PCC. The primary endpoint was the international normalised ratio (INR) 10 minutes after the end of 4-factor PCC infusion. Secondary endpoints were changes in coagulation factors, global clinical outcomes and incidence of adverse events (AEs). RESULTS: A total of 59 patients were randomised: 29 in the 25 IU/kg and 30 in the 40 IU/kg group. Baseline demographics and clinical characteristics were comparable between the groups. The mean INR was significantly reduced to 1.2 - and ≤1.5 in all patients of both groups - 10 minutes after 4-factor PCC infusion. The INR in the 40 IU/kg group was significantly lower than in the 25 IU/kg group 10 minutes (P = 0.001), 1 hour (P = 0.001) and 3 hours (P = 0.02) after infusion. The 40 IU/kg dose was also effective in replacing coagulation factors such as PT (P = 0.038), FII (P = 0.001), FX (P <0.001), protein C (P = 0.002) and protein S (0.043), 10 minutes after infusion. However, no differences were found in haematoma volume or global clinical outcomes between the groups. Incidence of death and thrombotic events was similar between the groups. CONCLUSIONS: Rapid infusion of both doses of 4-factor PCC achieved an INR of 1.5 or less in all patients with a lower INR observed in the 40 IU/kg group. No safety concerns were raised by the 40 IU/kg dose. Further trials are needed to evaluate the impact of the high dose of 4-factor PCC on functional outcomes and mortality. TRIAL REGISTRATION: Eudra CT number 2007-000602-73.