Postauthorization safety study of Clottafact® , a triply secured fibrinogen concentrate in acquired fibrinogen deficiency: a prospective observational study.

BACKGROUND AND OBJECTIVES: A postauthorization safety study was performed between 2009 and 2012 to describe the use of Clottafact® in acquired fibrinogen deficiency in real-life medical practice in France. MATERIALS AND METHODS: One hundred and fifty patients were planned for 28 days of prospective follow-up after infusion. The analysis of this observational study was descriptive and performed according to the type of treatment (curative or preventive) and the origin of the bleed. RESULTS: One hundred and fifty-six patients (16-87 years) were included in 13 centres and treated in five different medical bleeding situations: postpartum (59), other gynaecological/obstetrical (6), trauma (34), liver (13), cardiovascular (23) and other various bleeding situations (21). The mean follow-up time was 18·9 ± 12·3 days. Two patients presented adverse drug reactions: one a pulmonary embolism and the other a four-site venous thromboembolic episode. All were serious with a dubious causal relationship with the study treatment. Efficacy data were collected as a secondary objective. In 150 patients receiving curative treatment, 117 of 159 infusions (73·6%) were considered as successful by the investigators, 35 as moderate (22%) and seven as no response (4·4%). CONCLUSION: The Clottafact® safety profile observed during the study matched the known profile of fibrinogen during use.

[Risks acceptability related to obstetrical epidural analgesia]. / Acceptabilité des risques associés à la mise en place d'une analgésie péridurale obstétricale.

OBJECTIVES: Evaluation of the acceptability of complications related to obstetrical epidural analgesia in two populations, parturients and anesthesiologists. STUDY DESIGN: Prospective, transversal, single center study. MATERIALS AND METHODS: Evaluation of the acceptability of complications associated with obstetric epidural analgesia performed using a questionnaire of six clinical scenarii in two populations: parturients cared at the University maternity of Nancy and anesthesiologists of Lorraine. Patients were interviewed by an anesthesiologist, physicians via Internet. Acceptability was assessed using two tools, the absolute acceptability with a visual analog scale and the relative acceptability obtained by classifying clinical scenario against each other, in ascending order of acceptability. RESULTS: One hundred and forty-six parturients and 87 anesthetists assessed the acceptability of the different scenarios. The three less serious scenarios (hypotension, failure, dural tap) were acceptable for both populations. One case (spinal hematoma) was unacceptable for parturients. Three cases of varying severity (failure, dural tap, plexus injury with sequelae) were judged significantly less acceptable by patients than physicians (5.9 vs. 7.9 [P<0.001], 5.75 vs. 8.1 [P<0.01], 4.1 vs. 5.1 [P=0.035]). Multivariate analysis did not show any predictive factor of acceptability in both populations. CONCLUSION: In this study, the overall acceptability of the inherent complications of epidural analgesia was good in the two populations. It was essentially based on the notion of severity and preventability. A large interindividual variability was observed and a better acceptance by the anesthesiologists.

[Management of smoking in the perioperative period: survey of practices amongst anaesthetists in Lorraine]. / Prise en charge du tabagisme périopératoire : enquête de pratiques en région Lorraine.

INTRODUCTION: Evidence shows that smoking leads to more perioperative complications. Smoking cessation before surgery reduces this postoperative morbidity. The French Society of Anaesthesia and Intensive Care published recommendations on this subject in 2005. We wanted to assess knowledge and practice amongst anaesthetists in Lorraine as regards the management of smoking in the perioperative period. METHODS: We conducted an internet-based survey of 365 anaesthetists in the Lorraine region during November and December 2011. At the same time, we also surveyed patients attending pre-assessment clinic at the CHU hospital, Nancy. RESULTS: Half the practitioners surveyed were aware of the 2005 guidelines. Most pre-assessment clinics do not display posters warning of the perioperative hazards of smoking. The need for smoking cessation advice as a bare minimum is acknowledged by 47.9% of experienced practitioners; 76.3% of anaesthetists claim to offer advice occasionally, frequently or systematically. On the other hand, only 17% of the patients surveyed report receiving such advice. CONCLUSION: Despite published guidelines on the benefits of smoking cessation prior to surgery, Lorraine anaesthetists fail to systematically advise their patients in this regard. We believe there is a need to improve the management of these patients, either through the development of smoking cessation protocols locally or through patient referral to a specialised clinic.

[Patient associated fire in theatre: are we ready to prevent and/or manage it? Assessment of the anaesthetist's knowledge in Lorraine]. / Feu d'un patient au bloc opératoire: sommes-nous prêts à gérer ce type d'incident ? Résultats d'une enquête faite auprès des médecins anesthésistes-réanimateurs lorrains.

OBJECTIVE: To assess knowledge amongst anaesthetists as regards to fire involving surgical patients in Lorraine. STUDY DESIGN: A cross-sectional study was conducted using a postal questionnaire. METHOD: A 22-item postal questionnaire was therefore sent to all anaesthetists working in Lorraine between January and March, 2011. RESULTS: One hundred and twenty-eight questionnaires were returned (response rate: 36%). Sixty-two percent of the respondents had never participated in fire safety training. Fifty percent could not recollect the location of the fire extinguisher in their surgical unit. Sixty-three percent ignored the existence of a memo written by the Afssaps summarizing how to use safely alcohol-based skin preparations in the presence of an electrosurgical unit. Sixty-five percent gave at least one incorrect response in grading the various modes of oxygen supply regarding the risk of fire. Only 48% were able to identify the surgeries which posed the greatest fire risk. In such cases, 40% of respondents were not aware that a FiO(2) should be maintained below 30%, 43% that the use of nitrous oxide was forbidden and 32% that it was necessary to respect a drying time after the application of an alcohol-based solution. Concerning the management of a fire, most of the answers were correct. Finally, 97% of the respondents wished to be better informed on this particular topic. CONCLUSION: Our survey underlines a lack of knowledge amongst anaesthetists towards the risk of patient associated fire in theatre.

[Course of the anaesthesiology and intensive care unit residents in Lorraine, France]. / Parcours des anesthésistes-réanimateurs formés en Lorraine depuis 1996.

OBJECTIVE: The anaesthesiology and intensive care physician demography is becoming critical in most French regions; more than 56% of the residents trained in Lorraine are leaving the area after they graduate. METHODOLOGY: A descriptive and retrospective survey was carried out. The aims of the research were threefold: to ascertain firstly, why residents chose Lorraine in the first instance, secondly their experiences of the training and thirdly their expectations. The target group consisted of 76 former anaesthesia residents dating back to 1996. RESULTS: The response rate was 72.4%. Choosing Lorraine was based on its well-established teaching program (64%) and also on results achieved at National Medical Examination (85%). The academic medical training and working conditions were well-rated. A position was offered to 93% of the residents. Fifty-three percent stated having had previous work experience in the hospital as a decisive factor in taking up a position. By the end of the residency program, only 43.5% of anesthesia physicians remained in Lorraine; i.e., 79% were native to Lorraine and 25% born outside. Reasons given for leaving Nancy were: family (81%), more favourable climate (51%) and to go back to their region of origin (45%). CONCLUSION: Desired improvements would be: better performance of the Lorraine born students at the National Medical Examination, earlier and well-defined job offers, better communication within the team and consideration of the family situation as a whole.

[Assessment of hygiene practices in anaesthesia between 1998 and 2007 in Lorraine]. / Evaluation des pratiques d'hygiène en anesthésie entre 1998 et 2007 en Lorraine.

OBJECTIVES: To study the assessment of hygiene practices in anaesthesia in Lorraine between 1998 and 2007, after recommendations from the French Society of Anaesthesia and Reanimation (SFAR) in December 1997, and different local actions. STUDY DESIGN: Two surveys performed at a nine-year interval in Lorraine hospitals. POPULATION AND METHOD: Questionnaires about risk infection management and hygiene practices were sent by post to all anaesthetists, nurse anaesthetists and recovery room nurses in 1998 (n=279) and in 2007 (n=259). RESULTS: Between the two surveys multidrug-resistant bacteria signalling, movements of the staff in operating rooms, septic isolation protocol and management of single-use disposable anaesthesia material have been improved (p<0.05). Central venous catheters are less performed in recovery rooms and rings wearing decreased by 16% (p<0.05). Wearing of nonsterile gloves for peripheral venous catheter and intubation is not generalized (p<0.05). About half of the hospitals have cleanup procedures of anaesthesia furniture. Washing of hands by anaesthesia staff is not sometimes respected but it's more frequent for medicine preparation and between two operations. A good skin disinfection (cleaning - rinsing - drying - antiseptic) is more recurrent in 2007 (61.4%) than in 1998 (41.9%) for arterial catheter. Wearing of glasses for intubation is each times rare, about 15%. CONCLUSION: Hygiene practices in anaesthesia in Lorraine have been improved between the two surveys by recommendations from the Sfar and the work of the Antenne Régional de Lorraine (audits, manuals, formations). Promising progress has been made but some points must still be worked on.

[Impact of 2 strategies of analgesia on postoperative pain after emergency hand surgery performed on an ambulatory basis]. / Impact des modalités de prescriptions d'antalgiques sur la douleur postopératoire après chirurgie de la main réalisée en urgence en hospitalisation de jour.

OBJECTIVES: The assessment of the impact of various analgesic regimens on postoperative pain at home, following emergency and ambulatory hand surgery. STUDY DESIGN: Prospective comparative study of "before" and "after" groups by phone questionnaire on the first postoperative day. PATIENTS: All emergency and ambulatory surgery patients undergoing hand surgery in a specialist university hospital unit. METHODS: a) "Before" group (120 patients): analysis of current analgesic practice in the service (prescriptions by surgeon on duty), assessment of the incidence of pain scores with an intensity >/= 4 on a numerical score of 0 to 10, and identification of the most painful surgical interventions; b) formulation for these surgical interventions of multimodal analgesic protocols drown up by the anaesthetists; c) "After" group (51 patients): assessment of the efficacy of these analgesic protocols through comparison with the "before" group. RESULTS: a) "Before" group: the total incidence of pain scores with an intensity >/= 4 was 42% and in the case of conditions involving a joint or sepsis, 88%. Dextropropoxyfen-paracetamol alone was prescribed in 66% of cases and was associated with a 48% analgesic failure rate. Non-steroidal anti-inflammatory drugs were prescribed in 14% of cases, tramadol in 7% and a combination of drugs in 15%; b) "After" group: the incidence of pain scores with an intensity >/= 4 decreased to 21% in surgical interventions involving joints or sepsis (p < 0.001). CONCLUSION: Multimodal analgesic regimens are more effective than free prescriptions. This study underlines the need to further educate surgeons in this area. Despite these written protocols, there remains a 21% incidence of pain at home on day one.

[Comparison between 1.5% lidocaine with adrenaline and 1.5% plain mepivacaine in axillary brachial plexus block]. / Comparaison de la lidocaïne 1.5% adrénalinée et de la mépivacaïne 1.5% dans le bloc axillaire du plexus brachial.

OBJECTIVES: To evaluate the distribution of sensory blockade, the onset time and the duration of the axillary plexus block obtained after the administration of 40 mL of 1.5% lignocaine with adrenaline or 40 mL of plain 1.5% mepivacaine. STUDY DESIGN: Prospective, randomised, comparative, double blind study. PATIENTS AND METHODS: One hundred and fifty five patients undergoing hand surgery were randomised into two groups: in group L, 73 patients were given 1.5% lignocaine with 1/200,000 adrenaline and in group M, 82 patients received 1.5% mepivacaine. The entire volume was injected on the first evoked motor activity obtained for a current less than 0.5 mA. Sensory and motor block of each of the four major nerves of the hand and forearm were assessed using light touch and motor strength respectively. The block was considered complete when all nerves were anaesthetised (median, radial, musculocutaneous and ulnar). RESULTS: The percentage of complete sensitive blockade was 22% in group L and 24% in group M. Complete motor blockade was respectively 27% in group L and 40% in group M. The median time required to obtain a complete sensory blockade was 18 min for both group. The median time required to obtain a complete motor blockade was 17 min in-group L and 16 min in-group M. The duration of the sensory blockade was not different for both groups (i.e., 255 +/- 76 min versus 231 +/- 70 min in group L and M respectively. The duration of the motor blockade was longer in group L compared to group M (199 +/- 64 min versus 231 +/- 74 min respectively, p < 0.05). CONCLUSION: Following axillary plexus block, 1.5% mepivacaine improves neither the extension nor the duration of sensory blockade achieved by 1.5% lignocaine with adrenaline.

[Evaluation of the blood quality collected by cell-saver during cesarean section]. / Evaluation de la qualité du sang recueilli et traité par cell saver en cours de césarienne.

OBJECTIVE: To determine the quality of blood salvaged and processed during Caesarean section with a cell-saver. STUDY DESIGN: Laboratory study. PATIENTS: The study included 20 patients of ASA physical class 1 or 2 undergoing a scheduled Caesarean section. METHODS: A separate suction device was used from the beginning surgery until the delivery of the fetus, to remove most of the amniotic fluid coming from the surgical field. Thereafter using an Haemolite 2Plus (Haemonetics), the blood was separated and washed with 2 L of normal saline solution. Blood quality was assessed through detection of fetal cells and measuring out of alpha-fetal-protein, tissue factor. A Kleihauer test was also performed. RESULTS: Cell-saver processing removed most of alpha-fetal-protein and tissue factor while fetal cells were rarely seen. The Kleihauer test could not be performed because of haemolized blood samples. However, the results were very heterogeneous and after washing some salvaged units contained very high concentrations of alpha-fetal-protein or tissue factor. CONCLUSIONS: These preliminary results show that intra-operative autologous transfusion is not fully safe during Caesarean sections. In addition, there is an immunological risk if a significant part of fetal red blood cells are reinfused into maternal circulation. Therefore, additional studies are needed to better assess this risk.

Absence of in vivo lipid peroxidation in CdCl2-treated rats as measured by exhaled pentane.

We have used a new sensitive and non-invasive method, measuring exhaled pentane production, to evaluate in vivo lipid peroxidation (LP) in rats treated i.p. with CdCl2. Pentane, a by-product of LP, was measured 2, 6, 12, 24, 72 h and 8, 15, 22 days after treatment. No increase in pentane production was detected at these time periods for cadmium (Cd) doses reported to increase malondialdehyde (MDA) in major organs such as liver and lungs. This suggests that Cd cannot induce LP in vivo, but a prooxidant state which fragilized the tissues. Cd could also cause changes either in the production or in the metabolism of LP by-products (e.g. pentane).

[Outcome of transfusion practices in general hospitals in Lorraine]. / Evolution des pratiques transfusionnelles dans les centres hospitaliers généraux de Lorraine.

Authors carried out, in 17 public (non university) hospitals, a retrospective study on evolution of blood transfusion techniques in a french province (Lorraine). In every hospital, they obtained the annual consumption of blood or derivatives prescribed by the anaesthetists. Use of different sparing techniques was noted. All these parameters were connected to the anaesthetic and surgical activities. For statistical study, a Student test was used. Results demonstrate increasing anaesthetic and surgical activities. However the reduction of mean consumption of plasma and red blood cells is not significant. The sparing techniques are not fully used, partly because of too long distances from the blood centres. Blood prescriptions should and could be optimized.

[Comparative study of immunologic consequences of autotransfusion and homologous transfusion in lung cancer surgery]. / Etude comparative des conséquences immunologiques de l'autotransfusion et de la transfusion homologue en chirurgie carcinologique pulmonaire.

A study was carried out to determine the effects of transfusion with either autologous or homologous blood in 35 patients with lung cancer undergoing lung surgery. The patients were randomly allocated to two groups, "allo" receiving homologous blood (n = 10), and "auto" receiving autologous blood only (n = 13). A third control group included the patients (n = 12) who had not required any blood. In patients of "auto" group, two blood removals of 7 ml.kg-1 each were performed, provided their haemoglobin concentration was over 110 g.l-1 and their haematocrit over 34%. The following parameters were studied at t-1 (the day of inclusion), t0 (just before surgery and transfusion), t1 (one week after surgery), and t2 (one month later): haematocrit and haemoglobin concentration; IgG, IgA and IgM concentrations; polymorphonuclear and neutrophil leucocyte and lymphocyte numbers, lymphocyte subpopulations (CD4/CD8), activated natural killers (NK), polymorphonuclear leukocyte chemotaxis and chemoluminescence. Anaesthesia and surgery initiated initiated an early decrease in immunity in all three groups. The immune profile, and its time course in patients who received autologous blood only was similar to that of those who were not transfused at all. On the other hand, homologous blood transfusion seems to modify the recipient's non specific immune system. In group "allo", a decrease occurred in the number of auxiliary lymphocytes CD4, an increase in suppressor lymphocyte numbers CD8, with an increase in the CD4/CD8 ratio, and no increase in NK activity. These data suggest that autologous transfusion is well tolerated in cancer patients undergoing surgery.

[Analgesia after thoracotomy by extrapleural administration of continuous bupivacaine]. / Analgésie après thoracotomie par administration extrapleurale de bupivacaïne à débit continu.

This study was aimed to assess the efficiency and the side effects of a continuous administration of bupivacaine into the paravertebral space. Twenty patients, ranked ASA 2 or 3, with a mean age of 57.9 years, and having had a posterolateral thoracotomy for resection of lung tissue, were randomly assigned to one of two groups, B or C. At the end of the surgical procedure, a 22 gauge catheter was inserted into the paravertebral extrapleural space, at T4 levels As soon as pain occurred during recovery (T0), the patients were given two-hourly intravenous boluses of buprenorphine. The patients in group B were also given, through the paravertebral catheter, a 20 ml bolus of 0.25% bupivacaine, followed by a continuous steady rate infusion (10 ml.h-1). Group C patients were given normal saline in the same way. All patients could improve their analgesia with 0.05 ml boluses of buprenorphine given by an auto-analgesia pump (Pharmacia). The following parameters were assessed during the 72 h which followed the first injection: pain with a visual analogic scale, quality of sedation (5 grades), heart and breathing rate, systolic and diastolic blood pressure, arterial blood gases. In group B, plasma bupivacaine concentrations were measured throughout the infusion, and for an 8-hour period after its end. The statistical analysis included 15 patients only, as the catheter had moved into the chest cavity in the other 5. Analgesia was qualified to be adequate by all patients, but there was no statistically significant difference in the amounts of self-administered buprenorphine between groups B and C.(ABSTRACT TRUNCATED AT 250 WORDS)

[Current status of poisoning by ingestion of caustics: apropos of a series of 49 cases]. / Aspects actuels des intoxications par ingestion de caustiques: a propos d'une série de 49 observations.

The authors report the history of 49 patients, admitted to an intensive care unit after a caustic or corrosive ingestion. This series follows a similar one, related in 1979. An update is made for early evaluation and management, based on patients classification in three groups: severe cases, moderate cases, mild cases. Clinical and biological data, treatment and outcome for the three groups are related. The frequency and gravity of these poisonings appear to be the same as in the first series, with poor prognosis for extreme emergencies and high risk of oesophageal or gastric stricture for important forms. In this population, 20% of extreme emergencies have favorable outcome with early major surgical procedure.

[Antibioprophylaxis in pulmonary surgery: a randomized trial with cefamandole versus placebo]. / Antibioprophylaxie en chirurgie pulmonaire: étude randomisée céfamandole versus placebo.

A prospective double-blind study was designed to assess the efficacy of antibiotic prophylaxis in lung surgery. It included 114 patients undergoing lung surgery for primary or secondary malignant tumours randomly assigned to two groups. Group A patients (n = 59) were given cefamandole intravenously every four hours, three times, starting from induction of anaesthesia. The dose was determined according to the patient's weight: 1.5 g for patients weighing less than 60 kg, 2.5 g for those weighing between 60 and 80 kg, and 3 g for those above 80 kg. Group B patients (n = 55) were given a placebo at the same times. Nineteen other patients were excluded because either the tumour was found to be infected, or the patient had to be mechanically ventilated postoperatively, or an exploratory thoracotomy only was carried out, or they were allergic to beta-lactam antibiotics. The efficacy of antibiotic prophylaxis was assessed by recording the incidence of postoperative infections, the length of the patient's stay in hospital, and the need to use an antibiotic treatment. Patients, their sputum and wound were examined every day, and their temperature recorded. The white blood cell count and chest X-ray was carried out every day for the first week. All the drain and catheter tips were cultured, as well as sputum and blood (every three days). In case of infection, samples were obtained and cultured. Both groups of patients were similar with regard to age, risk factors (smoking habit, diabetes mellitus), and type of surgery (segmentectomy, lobectomy, pneumonectomy). There were 9 postoperative infections in group A, and 22 in group B (p = 0.003).(ABSTRACT TRUNCATED AT 250 WORDS)

[Sedation with intranasal midazolam for endoscopy of the upper digestive tract]. / Sédation par midazolam intranasal lors des endoscopies digestives hautes.

Twenty-nine patients, ranked ASA 1 or 2, scheduled for diagnostic gastroduodenal fibroscopy were randomly allocated into three treatment groups: intranasal midazolam (IN) 0.15 mg.kg-1; intramuscular midazolam (IM) 0.15 mg.kg-1, and placebo (P). Sedation and the fibroscopy were all carried out by the same anaesthetist and fibroscopist. Efficiency and tolerance of the method were assessed by monitoring the heart rate, systolic and diastolic arterial blood pressure, arterial oxygen saturation (pulse oximetry), the degrees of sedation, anxiety, and anterograde as well as retrograde amnesia. The patient's and endoscopist's reactions were also considered. Patients in group P were older than those of the other two groups (p less than 0.01). Sedation was more important and patients less anxious in groups IN and IM than in group P. Three patients in group IM had retrograde amnesia. There were no significant differences between the degrees of anterograde amnesia in the three groups. At no time during the study were there any significant differences in SpO2 between and within groups. Four out of the 9 patients in group P had a bad opinion of their experience, as compared with two out of the 20 in the midazolam groups; the difference was not statistically significant. Three hours after the procedure, all patients were fully awake. Intranasal administration of midazolam therefore seemed to be an interesting alternative for gastroduodenal fibroscopy, because it was simple, non traumatic, well tolerated, and did not result in arterial desaturation.