Erythropoietin to treat anaemia in critical care patients: a multicentre feasibility study.

Anaemia is common and associated with poor outcomes during and after critical illness. The use of erythropoietin to treat such anaemia is controversial with older studies showing mixed results. In this study, we aimed to evaluate the feasibility of performing a large multicentre randomised controlled trial of erythropoietin in this setting. We randomly allocated patients staying in the ICU for ≥ 72 h with haemoglobin ≤ 120 g.l-1 to either a weekly injection of erythropoietin (40,000 iu, maximum of five injections) or placebo (saline). The primary endpoint was feasibility (as measured by recruitment, randomisation and follow-up rates, and protocol compliance). Secondary endpoints included biological efficacy and clinical outcomes. Forty-two participants were recruited and randomly allocated, all participants received the allocated intervention, but one withdrew their consent and refused the use of their data, leaving 20 in the erythropoietin group and 21 in placebo group. Follow-up was completed for all patients who survived. The overall recruitment rate was 73.7% with 8.4 participants recruited on average per month. The last haemoglobin measured before hospital discharge (or death) was similar between the groups with a mean (SD) haemoglobin of 107 (21) vs. 95 (25) g.l-1 , mean difference (95%CI) 11 (-4-26), g.l-1 , p = 0.154. A large, multicentre randomised controlled trial of erythropoietin to treat anaemia in ICU patients is feasible and necessary to determine effects of erythropoietin on mortality in ICU anaemic patients.

Miconazole mucoadhesive buccal tablet in high-dose therapy with autologous stem cell transplantation (HDT/ASCT)-induced mucositis.

Oral mucositis is a major cause of morbidity in high-dose therapy/autologous stem cell transplantation (HDT/ASCT), where microbial colonization has an important pathological implication. In this study, we evaluated the impact of miconazole mucoadhesive buccal tablet (MBT) on mucositis-related complications. During two consecutive 34-month periods, patients treated with HDT/ASCT in our hematology department received either miconazole MBT (60 patients) or conventional oral amphotericin B suspensions three times a day (44 patients) in order to prevent or decrease chemotherapy-induced mucositis. The use of miconazole MBT is associated with less infectious complications as indicated by shorter antibiotic use (7.8 vs. 12.3 days; p < 0.0001), shorter intravenous antifungal use (1.4 vs. 3.6 days; p = 0.02), and a trend towards less yeast contamination in stool samples. Less patients required any analgesic drugs during hospitalization in the miconazole MBT group (18 vs. 7 %; p = 0.09). Indirect indicators of chemotherapy-induced mucositis (duration of hospitalization, morphine use) were in favor of miconazole MBT in patients with multiple myeloma (MM) but not for those with lymphoma. This study suggests that miconazole MBT provides a valid alternative to oral amphotericin B suspensions in regards to mucositis-related complications. A prospective and randomized study is warranted to establish the definite role of miconazole MBT.

The TPA score (total psoas muscle area) is the best marker for preoperative measurement of pre-sarcopenia in pancreatic surgery.

INTRODUCTION: Pre-sarcopenia, defined by the loss of muscle mass, is significantly associated with an increased risk of postoperative complications in digestive surgery, particularly pancreatic resection. The five predominant markers of sarcopenia are: psoas muscle area (TPA), intramuscular adipose tissue content (IMAC), Average Hounsfield Unit Calculation (HUAC), Skeletal Muscle Mass Index (MMI), and the ratio between visceral adipose tissue area and muscle surface area (VFA/TAMA). No standard reference marker has been determined. MATERIAL AND METHODS: This retrospective cohort included patients who underwent pancreatic resection at the University Hospital of Angers between January 2008 and June 2017. The goal was to determine the marker that was most significantly associated with morbidity and mortality in pancreatic surgery. The secondary objective was to determine the characteristics of pre-sarcopenic patients. RESULTS: The TPA score is the most sensitive marker for identifying patients at highest risk for immediate complications (P=0.008), proving far more sensitive than MMI (P=0.02), HUAC (P=0.34), IMAC (P=1), or VFA/TAMA (P=0.42). Postoperative mortality was 3.3% (n=5), morbidity was 63.8% (n=97). Pre-sarcopenic patients, as identified by the TPA index had significantly more immediate complications (71.2% versus 49.5%, P=0.008), in particular, more gastroparesis (P=0.02) and pancreatic fistula (P=0.03). CONCLUSION: In patients requiring pancreatic surgery, the prevalence of pre-sarcopenia is high and seems to be associated with a greater risk of immediate postoperative complications. The TPA score seems to be the most sensitive marker for detecting pre-sarcopenia. Evaluation of TPA preoperatively would make it possible to identify priority patients a priori who might benefit from pre-habilitation programs.

Clinical qualitative evaluation of the diagnosis of acute otitis media in general practice.

OBJECTIVES: Assess the quality of the diagnosis of acute otitis media (AOM) given by general practitioners (GPs) on a daily basis and compare it with the diagnosis of ear, nose and throat specialist (ENTS) which is considered as the gold standard. METHODOLOGY: Every GP had to include six children aged 1-4 years for whom he suspected or diagnosed that they were suffering from AOM. Parents had to accept to see the ENTS participating in the survey within 48 h. RESULTS: Twenty-four GPs took part in the survey and included at least one child, which amounts to a final 57% acceptability rate. Two hundred and eight eardrums were included in the survey. 21.9% of assumptions or diagnosis's of AOM (30/137) were declared null by the ENTS. GPs diagnose AOM without any doubt only in 54% of all cases. The diagnosis and the assumption of AOM were respectively confirmed in 83.8% of all cases and 71.4% by the ENTS. The combination of redness and bulge, and isolated redness accounted for respectively 44.3% and 26.2% of the main otoscopical factors reminiscent of the AOM according to GPs. In the case of redness and bulge, the diagnosis was confirmed in 83% of all cases by the ENTS as opposed to 75% regarding the isolated redness. An AOM was suspected in 57.1% of the eardrums barely or not visible or without any sign of infection and not confirmed in 25% of all cases. CONCLUSION: The global over diagnosis is 21.9% and 25% when the otoscopy is hindered by the presence of cerumen or when the eardrums are only inflammatory. Even though the over diagnosis is inferior to the one mentioned in published writings, post-graduate teaching on the various cerumen removal techniques and the use of pneumatic otoscopy could contribute to improving the quality of diagnosing AOM.

The impact of manual rotation of the occiput posterior position on spontaneous vaginal delivery rate: study protocol for a randomized clinical trial (RMOS).

BACKGROUND: The frequency of posterior presentations (occiput of the fetus towards the sacrum of the mother) in labor is approximately 20% and, of this, 5% remain posterior until the end of labor. These posterior presentations are associated with higher rates of cesarean section and instrumental delivery. Manual rotation of a posterior position in order to rotate the fetus to an anterior position has been proposed in order to reduce the rate of instrumental fetal delivery. No randomized study has compared the efficacy of this procedure to expectant management. We therefore propose a monocentric, interventional, randomized, prospective study to show the superiority of vaginal delivery rates using the manual rotation of the posterior position at full dilation over expectant management. METHODS: Ultrasound imaging of the presentation will be performed at full dilation on all the singleton pregnancies for which a clinical suspicion of a posterior position was raised at more than 37 weeks' gestation (WG). In the event of an ultrasound confirming a posterior position, the patient will be randomized into an experimental group (manual rotation) or a control group (expectative management with no rotation). For a power of 90% and the hypothesis that vaginal deliveries will increase by 20%, (10% of patients lost to follow-up) 238 patients will need to be included in the study. The primary endpoint will be the rate of spontaneous vaginal deliveries (expected rate without rotation: 60%). The secondary endpoints will be the rate of fetal extractions (cesarean or instrumental) and the maternal and fetal morbidity and mortality rates. The intent-to-treat study will be conducted over 24 months. Recruitment started in February 2017. To achieve the primary objective, we will perform a test comparing the number of spontaneous vaginal deliveries in the two groups using Pearson's chi-squared test (provided that the conditions for using this test are satisfactory in terms of numbers). In the event that this test cannot be performed, we will use Fisher's exact test. DISCUSSION: Given that the efficacy of manual rotation has not been proven with a high level of evidence, the practice of this technique is not systematically recommended by scholarly societies and is, therefore, rarely performed by obstetric gynecologists. If our hypothesis regarding the superiority of manual rotation is confirmed, our study will help change delivery practices in cases of posterior fetal position. An increase in the rates of vaginal delivery will help decrease the short- and long-term rates of morbidity and mortality following cesarean section. Manual rotation is a simple and effective method with a success rate of almost 90%. Several preliminary studies have shown that manual rotation is associated with reduced rates for fetal extraction and maternal complications: Shaffer has shown that the cesarean section rate is lower in patients for whom a manual rotation is performed successfully (2%) with a 9% rate of cesarean sections when manual rotation is performed versus 41% when it is not performed. Le Ray has shown that manual rotation significantly reduces vaginal delivery rates via fetal extraction (23.2% vs 38.7%, p < 0.01). However, manual rotation is not systematically performed due to the absence of proof of its efficacy in retrospective studies and quasi-experimental before/after studies. TRIAL REGISTRATION: ClinicalTrials.gov, Identifier: NCT03009435 . Registered on 30 December 2016.

Neurovascular microcirculatory vasodilation mediated by C-fibers and Transient receptor potential vanilloid-type-1 channels (TRPV 1) is impaired in type 1 diabetes.

Microvascular dysfunction may have an early onset in type 1 diabetes (T1D) and can precede major complications. Our objectives were to assess the endothelial-dependent (acetylcholine, ACh; and post-occlusive hyperemia, PORH), non-endothelial-dependent (sodium nitroprusside, SNP) and neurovascular-dependent (local heating, LH and current induced vasodilation, CIV) microcirculatory vasodilation in T1D patients compared with matched control subjects using a laser speckle contrast imager. Seventeen T1D patients - matched with 17 subjects according to age, gender, Body-Mass-Index, and smoking status - underwent macro- and microvascular investigations. The LH early peak assessed the transient receptor potential vanilloid type 1 channels (TRPV1) mediated vasodilation, whereas the plateau assessed the Nitirc-Oxyde (NO) and endothelium-derived hyperpolarizing factor (EDHF) pathways. PORH explored sensory nerves and (EDHF), while CIV assessed sensory nerves (C-fibers) and prostaglandin-mediated vasodilation. Using neurological investigations, we observed that C-fiber and A-delta fiber functions in T1D patients were similar to control subjects. PORH, CIV, LH peak and plateau vasodilations were significantly decreased in T1D patients compared to controls, whereas there was no difference between the two groups for ACh and SNP vasodilations. Neurovascular microcirculatory vasodilations (C-fibers and TRPV 1-mediated vasodilations) are impaired in TD1 patients whereas no abnormalities were found using clinical neurological investigations. Clinicaltrials: No. NCT02538120.

[National survey on short-term circulatory and/or respiratory support in 2009]. / Enquête nationale sur l'assistance circulatoire et respiratoire de courte durée en 2009.

OBJECTIVE: Indications for short-term circulatory and/or respiratory support (STCRS) increased during the last years. The goal of this survey was to characterize this activity in France in 2009. STUDY DESIGN: Observational retrospective pluricentral. MATERIAL AND METHODS: Each center of cardiothoracic surgery received a questionnaire validated by the Société française de perfusion about the activity, materials and organization used for STCRS. Data were expressed as percentages or median (25-75 percentiles). RESULTS: Forty-one centers on 61 (67%) answered. STCRS was performed respectively by 33 (80.5 %), 36 (87.8 %) and 39 (95.1 %) of centers in 2007, 2008 and 2009 including 10 [4-26], 18 [6-29] and 18 [5-33] cases/center per year. In 2009, types of STCRS installed were veno-arterial in 39 centres (95.1 %), veno-venous in 27 (65.9 %) and Novalung(®) in four (9.8 %), including 18 [5-32], five [2-7] and 15 [1-17] cases respectively. Twenty-nine centers (70.7%) installed STCRS outside the operating theater, and 24 (58.5%) in non-cardiothoracic surgery. A mobile circulatory support unit was created in eight centers (19.5%), however 21 (51.2%) have installed STCRS externally, at distances between 10 [5-55] to 100 [15-200] km, using emergency vehicles in most of the cases (90.5%), but helicopter seldom (19%). CONCLUSION: STCRS has increased over the last few years in France. Externalized activity outside the operating theater was important, time-consuming and used hospital resources therefore modifying the professional activity of perfusionists.

Perineal infiltration with lidocaine 1%, ropivacaine 0.75%, or placebo for episiotomy repair in parturients who received epidural labor analgesia: a double-blind randomized study.

BACKGROUND: Episiotomies are performed in approximately 20% of vaginal deliveries and may result in postpartum pain. Perineal infiltration with lidocaine during the episiotomy is widely used, despite an early study showing no difference when compared with saline. Ropivacaine has increasingly been used in the obstetric setting, although not for episiotomies. We sought to compare the analgesic efficacy of ropivacaine, lidocaine or saline for perineal infiltration before repair of a mediolateral episiotomy in patients who delivered with epidural labor analgesia. METHODS: In this double-blind randomized prospective study, infiltration with 15 mL of 0.75% ropivacaine, 1% lidocaine, or saline was performed immediately before initiating the perineal repair. During the first 24 h, the time to the first oral analgesic, analgesic intake, visual analog scale scores for pain, and patient satisfaction scores were recorded. RESULTS: A total of 154 patients were included. Demographic data were comparable between the groups. Time to first oral analgesic request was 13.9h with 0.75% ropivacaine, 17.0 h with 1% lidocaine, and 16.6 h with saline (P=0.104); the proportion of patients who did not request oral analgesics were 35%, 54% and 53%, respectively (P=0.09). Visual analog pain scores were low and not different between the three groups (ropivacaine 16.8+/-11.6, lidocaine 12.4+/-9.7; and saline 16.2+/-11.5, P=0.08). CONCLUSION: For the first 24 h, perineal infiltration of ropivacaine, lidocaine, and saline were equivalent in producing post-episiotomy analgesia.