[Closed claims in obstetrics: A study based on French Sham insurance data]. / Sinistralité en obstétrique dans les hôpitaux publics français: données Sham.

OBJECTIVE: The aim of this study was to analyze the medicolegal claims related to obstetrics in French hospitals. MATERIAL AND METHODS: We did retrospective study on insurance claims provided by Sham insurances and which has been settled by a court over a 3-year period (2004-2006). RESULTS: We analyzed 66 closed claims that occurred between 1983 and 2005 in French hospitals (54 general hospitals and 12 academic). The average time between the declaration of the claim and the court conviction was 6 years. The average amount of compensation per claim was 500,000 €. The damage occurred during vaginal delivery (n=44), planned (n=5) or unplanned (n=4) cesarean. The more often claims are fetal asphyxia (n=24) or shoulder dystocia (n=8). The consequences are very important: cerebral palsy (16), death of the newborn (12), death of the mother (2) or brachial plexus injuries (6). CONCLUSION: The causes identified by the expert are always multifactorial with generally a misdiagnosis (n=27), a decision making error (n=36), a care error by the midwife (n=21) and/or a delay in medical care (n=13). These data should help strengthen the quality approach in obstetrics.

6% Hydroxyethyl starch (130/0.4) vs Ringer's lactate preloading before spinal anaesthesia for Caesarean delivery: the randomized, double-blind, multicentre CAESAR trial.

BACKGROUND: Vasopressor administration is recommended to prevent hypotension during spinal anaesthesia (SA) for elective Caesarean delivery. We aimed to test the superior efficacy and ensure safety of a hydroxyethyl starch (HES) vs a Ringer's lactate (RL) preloading, when combined with a phenylephrine-based prophylaxis. METHODS: A total of 167 healthy parturients undergoing elective Caesarean delivery under SA were included in this multicentre, randomized, double-blind study. Patients received 500 ml of 6% HES (130/0.4)+500 ml of RL (HES group) or 1000 ml of RL (RL group) i.v. before SA. After SA, i.v. phenylephrine boluses were titrated when systolic arterial pressure (SAP) was below 95% of baseline. The primary outcome was the incidence of maternal hypotension (SAP <80% of baseline). RESULTS: The incidence of both hypotension and symptomatic hypotension (i.e. with dizziness, nausea/vomiting, or both) was significantly lower in the HES group vs the RL group: 36.6% vs 55.3% (one-sided P=0.025) and 3.7% vs 14.1%. There was no significant difference in total phenylephrine requirements [median (range): 350 (50-1800) vs 350 (50-1250) µg]. The decrease in maternal haemoglobin value the day after surgery was similar in the two groups [1.2 (1.0) vs 1.0 (0.9) g dl(-1)]. There was no detectable placental transfer of HES in six umbilical cord blood samples analysed in the HES group. Neonatal outcomes were comparable between the groups. CONCLUSIONS: Compared with a pure RL preloading, a mixed HES-RL preloading significantly improved prevention of both hypotension and symptomatic hypotension based on early phenylephrine bolus administration and did not induce adverse effects. CLINICAL TRIAL REGISTRATION: NCT00694343 (http://clinicaltrials.gov).

[Epidemiology of the medico-legal risk associated with the practice of ambulatory surgery in France: a study based on insurance data]. / Épidémiologie du risque médico-légal lié à la pratique de la chirurgie ambulatoire en France: données SHAM.

UNLABELLED: The medico-legal risk specifically associated with the practice of ambulatory surgery is still not well studied. SHAM insurances are the biggest French provider of medical liability insurances. The study of the insurance claims provided by this insurer is therefore a relevant source of data on the complications related to ambulatory surgery. OBJECTIVE: The aim of this study was to compare the claim rate related to ambulatory surgery with non-ambulatory surgery. STUDY DESIGN: We did a retrospective study on insurance claims provided by SHAM insurances between 2007 and 2011 to compare the claim rate related to ambulatory surgery with non-ambulatory surgery. MATERIALS AND METHODS: We searched the files in the SHAM database, and then analyzed them. RESULTS: On the study period, out of a total of 29565 registered claims, 467 (1.6%) originated from ambulatory surgery. On the total of 29,098 registered claims for non-ambulatory surgery, 2151 (7.4%) led to a condemnation whereas the rate was 7% (33 out of 467 claims) for ambulatory surgery. The condemnations linked to ambulatory surgery amounted to 1.5% of the total (33 out of 2184), for a cost of 1.7 M€ (versus 400,3 M€ for non-ambulatory surgery). The average cost of a compensation is therefore 50,500 € for ambulatory surgery and 186,000 € for non-ambulatory surgery. The medical specialties concerned are primarily ophthalmology, abdominal and orthopedics surgery. The main identified causes were medical errors (n=16) and nosocomial infections (n=13). CONCLUSIONS: The claim rate in ambulatory surgery is proportionally less frequent with compensations three times less and were related to the most frequent type of surgery done in ambulatory settings. These data should help strengthen quality approach in ambulatory surgery.

[Enhanced recovery after Caesarean delivery: a practice survey in two French regions]. / Réhabilitation précoce après césarienne programmée : enquête de pratique auprès des maternités des régions Provence - Alpes - Côte d'Azur et Île-de-France.

AIMS: Although most components of an enhanced recovery programme (ERP) can be applied to caesarean delivery, it is unknown if their implementation is large in France. TYPE OF STUDY: Structured interview by telephone or e-mailing of an anaesthetist to describe usual perioperative practice in two French regions (Provence - Alpes - Côte d'Azur [PACA] and Île-de-France [IDF]). METHODS: Questionnaire related to scheduled caesarean delivery. RESULTS: Response rate 74% (111/149 maternity units). Multimodal analgesia was almost universally applied and intrathecal/epidural morphine used by 86% of respondents. Oral administration of analgesic drugs was started before h24 in 50% of responding units and immediately after delivery in 7% of them. The urinary catheter was withdrawn after h24 in 71% of responding centres. Women were allowed to drink between h4 and h6 (60%), in an unlimited amount (79%). The first meal was authorised after h6 (89%) but before h24 (65%) or after recovery of bowel function (13%). Oxytocin was used in 69% of respondents and maintained postoperatively for 12 to 24hours (70% of oxytocin users). Carbetocin was used in the remaining 31%, usually without any maintenance oxytocic drug. Attributing one point to each major component of the ERP protocol (0-6), the median value was 3 (2-4). An ERP protocol was available in 14% of responding units and was associated with a shorter duration of intravenous and urinary catheters use. CONCLUSION: The study shows that the components of an ERP are insufficiently implemented in France after caesarean delivery. Moreover, significant heterogeneity exists between maternity units and among regions.

Performance of alfentanil target-controlled infusion in normal and morbidly obese female patients.

BACKGROUND: Available alfentanil pharmacokinetic (PK) sets for target-controlled infusion (TCI) were derived from populations with normal BMI. The performance and accuracy of the models devised by Maitre and colleagues and Scott and colleagues were evaluated in a population including morbidly obese patients. METHODS: Alfentanil TCI using Maitre and colleagues' model was administered to 10 obese and six non-obese women (BMI 19.5-57.4 kg m(-2)) undergoing laparoscopic surgery. The initial effect-site target concentration was 100 ng ml(-1). Alfentanil arterial plasma concentrations were sampled from TCI onset to 220 min after its termination. Stanpump(®) software calculated predicted alfentanil concentrations. Data were analysed with a non-linear mixed-effect model (NONMEM, version 7.2), including calculations of the median performance error (MDPE) and the median absolute performance error (MDAPE). Scott and colleagues' model was evaluated retrospectively. RESULTS: Using Maitre and colleagues' model, MDPE and MDAPE (range) for the whole population were 13.3% and 23.9%, respectively. With Scott and colleagues' model, MDPE and MDAPE were -30.7% and 50.1%, respectively. We created a three-compartment model with BMI as the covariate (CL), yielding MDPE 1.1% and MDAPE 30.6%. CONCLUSIONS: Maitre and colleagues' PK set underestimated the predicted concentrations in our mixed-weighted population, but its bias and accuracy were acceptable for clinical application. Scott and colleagues' model was inaccurate. The NONMEM model seemed to be more accurate during the infusion and for high concentrations, but it needs to be validated in a larger population.

[Anaesthesia for HIV-infected patients]. / Anesthésie du patient infecté par le VIH.

France is one of main countries affected by the HIV-outbreak in Europe with more than 120,000 cases, among which 34,600 patients having developed an AIDS. The antiretroviral combination therapies (combined antiretroviral therapy [cART]) reduced by half the mortality. A low compliance to cART alters the virologic control and increases the morbimortality. If required, the therapeutic break should be the shortest possible, including the whole treatment (to limit the risk of viral resistance). The perioperative care should take into account the underlying conditions. During the preoperative period, the clinical picture could combine various complications: 1: respiratory impairment; 2: impairment of neuronal functions (related to viral factors, host response and environmental factors such as alcohol, drug addiction, HCV co-infection) inducing a cognitive dysfunction or a peripheral neuropathy; 3: lipodystrophy, dyslipidemia and insulin resistance are the main metabolic cART-related side effects, responsible for atherosclerosis and coronaropathy; 4: major nutritional impairment. Anesthesia for HIV patients is almost the same than usual, without HIV-related contraindication to regional anesthesia. Anesthetic drugs can be associated to cART. The main restriction belongs to the protease inhibitors, which could affect the metabolic pathways of opioids, NSAIDs and benzodiazepines (over dosage risks). During the postoperative period, the follow-up should include the thromboembolism prevention (increased risk compared to main people), the cardiovascular side effects, the nutritional status and the continuation of the treatment. Moreover, the psychological status related and a close collaboration with the corresponding physician is critical.

[Check-list "Patient Safety" in the operating room: one year experience of 40,000 surgical procedures at the university hospital of Nice]. / Check-list "Sécurité du patient au bloc opératoire": une année d'expérience sur 40 000 interventions au centre hospitalier universitaire de Nice.

OBJECTIVES: The implementation of the check-list "Safe surgery saves live" (CL) has proven effective to reduce morbidity and perioperative mortality. Since 1st January 2010 it is a requirement of the HAS as part of the process of certification of hospitals. The CL has been established on all the operating rooms of our hospital after the onset of a near accident. METHODS: The CL has been computerized to facilitate its adoption by professionals. An internal benchmarking was immediately implemented to allow each surgical specialty to benchmark themselves with other teams. We conducted an audit concerning the CL and periodic assessments in order to learn more precisely concerning the expectations and feelings of medical and nursing teams. RESULTS: Nearly 40 000 CL were collected in the patient record. The completeness of information of some items seems to reflect the difficulty for professionals to realize the difference between traceability and information sharing within the team on the implementation of a protocol. This audit has confirmed the difficulty in sharing information orally. CONCLUSIONS: The CL is involved in developing a safety culture in the operating room and led to the establishment of a risk mapping in the operating room and the recovery room and participation in the program error prevention procedure and surgical site through international program "High 5s" whose purpose is to improve the safety of care.

Sevoflurane but not propofol increases interstitial glycolysis metabolites availability during tourniquet-induced ischaemia-reperfusion.

BACKGROUND: Ischaemia/reperfusion (I/R) is one of the main pathophysiological phenomena involved in the anaesthetic practice. The authors hypothesized that anaesthetic regimens can influence skeletal muscle tolerance to tourniquet-induced I/R that should be reflected by the interstitial metabolite levels of anaerobic glycolysis. METHODS: Microdialysis probes were implanted in three groups of 10 patients each receiving either sevoflurane (SEVO), propofol (PRO), or spinal (SA) anaesthesia (for induction and maintenance). SA group was considered as a control group. Interstitial fluid was obtained during tourniquet-induced I/R and was analysed for interstitial glucose, lactate, pyruvate, and glycerol. RESULTS: The microdialysis flow rate was 0.5 microl min(-1). Compared with the control group, the SEVO group had a higher level of both lactate and pyruvate and an increase in glucose during ischaemia. In contrast, the PRO group had a lower level of pyruvate, resulting in a significant higher increase (eight times from baseline) of the lactate pyruvate ratio. Glucose level remained low in this group. During reperfusion, lactate, pyruvate, and glucose remained at a significantly higher level in the SEVO group. In the PRO group, there was no difference in lactate, pyruvate, and glucose levels compared with the control group. The interstitial level of glycerol exhibits only few and comparable changes during I/R between the groups. CONCLUSIONS: Our results indicate that there is a better availability of interstitial glycolysis metabolites (glucose, lactate, and pyruvate) in the skeletal muscle during ischaemia and reperfusion after sevoflurane exposure than after propofol, suggesting a potential preconditioning effect of sevoflurane on tourniquet-induced skeletal muscle I/R.

[Transfusion safety and haemovigilance committees]. / Le comité de sécurité transfusionnelle et d'hémovigilance.

Transfusion safety and haemovigilance committees (TSHC) were initially created in the public health care sector. Nowadays, they are also a mandatory committee of private health care institutions. The members of the TSHC, as well as the way the committee is driven and organized, are defined by law. The aim of the committee is focused on the management of transfusion safety and haemovigilance. The TSHC takes part in the improvement of the safety of transfused patients, and monitors the applying of haemovigilance rules. It also handles the training of all staff members involved in the blood transfusion process.

Impact of walking epidural analgesia on obstetric outcome of nulliparous women in spontaneous labour.

BACKGROUND: To explore the effects of walking epidural analgesia on obstetric and neonatal outcomes, we performed a case-control study. METHOD: Each nulliparous woman receiving walking epidural analgesia using 0.0625% bupivacaine (n = 44) was matched to two nulliparous historical controls receiving 0.125% or 0.25% bupivacaine (n = 88 each) for epidural analgesia while recumbent. RESULTS: Maternal and obstetric parameters, fetal status and presentation, and oxytocin use were comparable among groups. Those receiving walking epidural analgesia walked for a mean of 60 min (range: 20-75 min). In the control groups the mean total durations of labour were shorter (58 min in the 0.125% group and 99 min in the 0.25% group, P < 0.05). Significantly fewer walking epidural analgesia cases than controls required instrumental vaginal delivery (P < 0.05). No other differences in obstetric or fetal outcome were observed and no mother fell or stumbled while walking. CONCLUSION: Although it was associated with a prolonged first stage of labour, walking epidural analgesia appeared safe for nulliparous women and their babies.

Improvement of surgical antibiotic prophylaxis: a prospective evaluation of personalized antibiotic kits.

This prospective study compared personalized surgical antibiotic prophylaxis kits (SAPKs) with freely prescribed antibiotics. SAPKs use significantly enhanced national guidelines on surgical antibiotic prophylaxis application (82% vs 41%, P < 0.001), and result in limited errors in terms of antibiotic choice (3% vs 28%, P < 0.001), timing of administration (12% vs 24%, P = 0.003) and prophylaxis duration (1.5% vs 22%, P < 0.001), thereby demonstrating their effectiveness.

Prostate anaesthetic block with ropivacaine for urologic surgery.

BACKGROUND AND OBJECTIVE: The aim of this study was to evaluate prostate anaesthetic block for haemodynamic tolerance and quality of analgesia during and after transurethral surgery. METHODS: Ninety adult males, ASA III/IV, were randomly assigned to receive a prostate anaesthetic block (n = 45) or spinal anaesthesia (n = 45). The main outcome measurement during anaesthesia, surgery and recovery was haemodynamic tolerance (number of hypotensive episodes, heart rate, systolic and mean blood pressures). Other outcome variables were pain scores during anaesthesia, surgery and every 4 h until 24 h after the end of surgery and amount of oral morphine required during the 24-h postoperative period. RESULTS: Sixty-six patients were ASA III and 24 ASA IV. Ongoing cardiovascular therapies were comparable between groups. All surgical procedures were performed under good conditions. For patients receiving prostate anaesthetic block, the blood pressure and heart rate did not change significantly during the study period. For patients receiving spinal anaesthesia, the hypotension rate was 55.6% (n = 25) compared to 0 in the prostate anaesthetic block group (P < 0.001); 25 and 4 patients, respectively, required vascular filling and additional ephedrine administration. In both groups, all pain scores were <40 (100 mm visual analogue scale) during the study period. Oral morphine was given during the postoperative period to two prostate anaesthetic block patients and four who had received spinal anaesthesia (not significant). CONCLUSION: Transurethral surgery under prostate anaesthetic block is safe and assures adequate analgesia during and after surgery.

Comparison of manufacturers' specifications for 44 types of heat and moisture exchanging filters.

BACKGROUND: Although heat and moisture exchanging filters (HMEF) are recommended for use during anaesthesia, the criteria for choosing a filter are not clearly defined. Manufacturers offer many different types of HMEF with various technical characteristics. We compared the technical specifications provided by the manufacturers for different types of HMEF. METHODS: Filter manufacturers were asked to provide technical information. Additional information was obtained from websites. Information about 44 filters (16 mechanical and 28 electrostatic) was collated. RESULTS: Filter performances were estimated with different sizes of microorganism and durations of challenge. Twenty-eight filters had not been tested by independent laboratories. For 12 of the filters, information obtained from websites and from the manufacturers differed. Most filter specifications claimed high efficiency, particularly for filtration, microbial challenge number and test duration. Electrostatic filters used in anaesthesia were claimed to have high filtration efficiency, similar to the efficiency provided by mechanical filters. Excluding moisture output values did not alter the general conclusions. CONCLUSIONS: Technical aspects of the tests, international standards, and independent validation should be considered when a filter is chosen.

[Antimicrobial prophylaxis in surgical procedures: assessment of the guidelines application and validation of antibiotic prophylaxis kits]. / Antibioprophylaxie chirurgicale: évaluation de l'application des recommandations et validation des kits d'antibioprophylaxie.

INTRODUCTION: Surgical wounds infections represent a major cause of morbidity and are at the origin of an increase in the postoperative mortality rate. Those infections represent in France one-fourth of the nosocomial infections. Combine with the elementary hygiene rules and the surgical "good practices", antimicrobial prophylaxis with antibiotics is an essential tool for the reduction of the surgical wound infections rate. In the French hospitals, antimicrobial prophylaxis represents one-third of the antibiotic prescriptions. The rules for the application of surgical prophylaxis are based on current guidelines for antibiotic prophylaxis, however, guidelines are not totally respected. MATERIALS AND METHODS: Study 1: assessment of the guidelines application (practical audit) of the antibiotic antimicrobial prophylaxis in surgery, and of their impact on the established prescriptions: three audits were realized with four years interval (1994, 1998 and 2002), in order to estimate the evolution in the application of the current guidelines, which indirectly estimate the evolution of the guidelines impact. Study 2: assessment of the use of an antibiotic kit through a prospective comparative study of two groups: exposed patients vs non-exposed patients. Nominatives kits contained the recommended antibiotics with recommended posology and the instructions for each surgical procedure. RESULTS: Study 1: this study showed a significant increase in the antibiotics prescription volume since 1994 (+23%). After a temporary increase from 1994 to 1998, the conformity of the effective prescriptions with the current guidelines for the indication to realize or not to realize an antibiotic surgical prophylaxis decreases of 7% between 1998 and 2002. Nevertheless, we noticed an overall improvement in the guidelines application for the modalities of the antimicrobial prophylaxis when it was prescribed in a valid indication. Persistent weak points were in 2002 the antibiotic molecule choice (error rate of 25%), the duration of prescription (rate of abnormal prolonged antibiotic prophylaxis of 19%), and the timing of administration (error rate of 31%). Study 2: antibiotic kits have permitted to increase the accordance of the antimicrobial prophylaxis prescriptions with the guidelines. Antibiotic prophylaxis was in total agreement with guidelines for 82% of exposed patients vs 41 for non-exposed patients. Choice of the antibiotic molecule, timing of administration and duration of prescription were the parameters particularly well rectified by this new antibiotic prophylaxis technical. CONCLUSION: In this study, guidelines diffusion seems to be an essential but also an insufficient point for the improvement of the quality prescriptions in surgical antimicrobial prophylaxis. The "day by day" nominative antibiotic prophylaxis deliverance in the shape of a << ready to use >> antibiotic kit went with an increase in the respect of the recommendations, by correcting in a significant way the persistent weak points identified during the first part of our study. The antibiotic prescriptions control is an imperative goal in individual health (the patient himself), but also in public health (the community). This radical change in habits is listed in a policy of antimicrobial agent prescription improvement (best efficacy with less cost).

[Assessment of 44 heat and moisture exchange filters. What to choose?]. / Evaluation de 44 filtres échangeurs de chaleur et d'humidité. Que choisir?

OBJECTIVES: If the use of heat and moisture exchange filter (HMEF) in anaesthesia is recommended by the French Society of Anaesthesia and Intensive Care (SFAR), the criteria's choice are not clearly defined. Many HMEF are proposed by manufacturers which technical characteristics are different. STUDY DESIGN: The aim of this study was to evaluate the HMEF using items of the American Association of Respiratory Care (AARC) and technical dossiers. METHODS: All manufactures producing filters have been contacted to give their technical dossiers. Forty-eight filters have been analyzed (13 mechanical filters, 31 electrostatic filters). Each item has been scaled 0, 5 or 10. The final result was on 10. RESULTS: Seventeen filters had a note superior to 5. There were 8 mechanical filters and 9 electrostatic filters. The difference between the filters was the size of the micro-organisms tested and the duration of the test. Some filters were not tested by independent laboratories (N = 8). There were differences between the commercial documentation and on Internet and the technical dossiers (N = 12). DISCUSSION: We noted the good quality of the filters particularly concerning criters recommended by the Sfar (filter medium, filtration efficiency, microbial challenge number and duration of the test). The electrostatic filters recently used in anaesthesia have high performance concerning filtration efficiency. To supprime the moisture output criteria did not change the results. CONCLUSIONS: Criteria's used by manufactures to evaluate there filters are not always precised or too restrictive. The technical tests, the international norms, the certificates of validation, the ergonomic qualities and the definition of our needs are the main elements of choice of a filter.

Clonidine premedication improves metabolic control in type 2 diabetic patients during ophthalmic surgery.

BACKGROUND: In stressful conditions, increasing blood glucose concentrations are closely related to an increase in catecholamines and cortisol release. Clonidine, a centrally acting alpha(2)-adrenoceptor agonist, has neuroendocrine effects, including inhibition of sympathoadrenal activity. We therefore evaluated the effect of clonidine on blood glucose control and insulin requirements during ophthalmic surgery when given as premedication in type 2 diabetic patients. METHODS: After randomization, patients were premedicated with clonidine or flunitrazepam (control). Patients were given insulin by continuous i.v. infusion to maintain blood glucose in the range 5.5-11.1 mmol litre(-1). Blood glucose concentrations were measured every 15 min during surgery, and hourly for 6 h after surgery. Plasma C-peptide and counter-regulatory hormones were also measured. RESULTS: Glycaemia was significantly lower in the clonidine group (P<0.01) and the median amount of insulin administered was significantly reduced: clonidine group 9.0 (interquartile range 5.1) units; control 18.6 (10.2) units; P<0.01). Plasma catecholamine concentrations were lower in patients given clonidine (P<0.05) but there was no difference in cortisol concentrations. CONCLUSION: Premedication of type 2 diabetic patients with clonidine 90 min before surgery improves blood glucose control and decreases insulin requirements during ophthalmic surgery.

Comparison of the effects of sevoflurane and propofol on cortical somatosensory evoked potentials.

BACKGROUND: Propofol (P) and sevoflurane (S) are potential anaesthetic agents if electrophysiological monitoring is required during spinal surgery. They allow rapid recovery and do not depress cortical somatosensory evoked potentials (SSEP) as much as other agents. The effects of these agents on SSEP have not been compared before. METHODS: Twenty-four patients were allocated randomly to receive either S (n = 12) or P (n = 12). SSEP evoked by electrical stimulation of the posterior tibial nerve at the ankle were recorded before anaesthesia. The cortical potential P40 was recorded (latency P40 and amplitudes N29P40 and P40N50). The anaesthetic concentration was adjusted gradually to obtain three predetermined ranges of values of bispectral index (BIS): 45-55, 35-45 and 25-35. For each range, a stable state was maintained for 10 min and SSEP were recorded. RESULTS: For the BIS 45-55 range, compared with preoperative values, P40 latency increased during S [mean change +2 (SD 0.6) ms] but not during P [+0.4 (0.2) ms (P = 0.12)] and both amplitudes (N29P40 and P40N50) decreased with S. Increasing S concentration caused a dose-dependent depression of SSEP. P did not have a statistically significant effect on the recordings and the signals remained stable in each BIS range. CONCLUSION: Sevoflurane affected SSEP recordings in a dose-dependent fashion. Propofol had a minimal effect on SSEP recordings.