Validation of the French version of the Hospital Survey on Patient Safety Culture questionnaire.

OBJECTIVE: To assess the psychometric properties of the French version of the Hospital Survey on Patient Safety Culture questionnaire (HSOPSC) and study the hierarchical structure of the measured dimensions. DESIGN: Cross-sectional survey of the safety culture. SETTING: 18 acute care units of seven hospitals in South-western France. PARTICIPANTS: Full- and part-time healthcare providers who worked in the units. INTERVENTIONS: None. MAIN OUTCOME MEASURES: Item responses measured with 5-point agreement or frequency scales. Data analyses A principal component analysis was used to identify the emerging components. Two structural equation modeling methods [LInear Structural RELations (LISREL) and Partial Least Square (PLS)] were used to verify the model and to study the relative importance of the dimensions. Internal consistency of the retained dimensions was studied. A test-retest was performed to assess reproducibility of the items. RESULTS: Overall response rate was 77% (n = 401). A structure in 40 items grouped in 10 dimensions was proposed. The LISREL approach showed acceptable data fit of the proposed structure. The PLS approach indicated that three dimensions had the most impact on the safety culture: 'Supervisor/manager expectations & actions promoting safety' 'Organizational learning-continuous improvement' and 'Overall perceptions of safety'. Internal consistency was above 0.70 for six dimensions. Reproducibility was considered good for four items. CONCLUSIONS: The French HSOPSC questionnaire showed acceptable psychometric properties. Classification of the dimensions should guide future development of safety culture improving action plans.

Auscultation in flight: comparison of conventional and electronic stethoscopes.

OBJECTIVES: The ability to auscultate during air medical transport is compromised by high ambient-noise levels. The aim of this study was to assess the capabilities of a traditional and an electronic stethoscope (which is expected to amplify sounds and reduce ambient noise) to assess heart and breath sounds during medical transport in a Boeing C135. METHODS: We tested one model of a traditional stethoscope (3MTM Littmann Cardiology IIITM) and one model of an electronic stethoscope (3MTM Littmann Stethoscope Model 3000). We studied heart and lung auscultation during real medical evacuations aboard a medically configured C135. For each device, the quality of auscultation was described using a visual rating scale (ranging from 0 to 100 mm, 0 corresponding to "I hear nothing," 100 to "I hear perfectly"). Comparisons were accomplished using a t-test for paired values. RESULTS: A total of 36 comparative evaluations were performed. For cardiac auscultation, the value of the visual rating scale was 53 ± 24 and 85 ± 11 mm, respectively, for the traditional and electronic stethoscope (paired t-test: P = .0024). For lung sounds, quality of auscultation was estimated at 27 ± 17 mm for traditional stethoscope and 68 ± 13 for electronic stethoscope (paired t-test: P = .0003). The electronic stethoscope was considered to be better than the standard model for hearing heart and lung sounds. CONCLUSION: Flight practitioners involved in air medical evacuation in the C135 aircraft are better able to practice auscultation with this electronic stethoscope than with a traditional one.

Mortality related to anaesthesia in France: analysis of deaths related to airway complications.

Death certificates from the French national mortality database for the calendar year 1999 were reviewed to analyse cases in which airway complications had contributed to peri-operative death. Respiratory deaths (and comas) found in a previous national 1978-82 French survey (1:7960; 95% CI 1:12,700 to 1:5400) were compared with the death rate found in the present one: 1:48,200 (95% CI 1:140,000 to 1:27,500). In 1999, deaths associated with failure of the breathing circuit and equipment were no longer encountered and no death was found to be related to undetected hypoxia in the recovery unit. Deaths related to difficult intubation also occurred at a lower rate than in the previous report (1:46,000; 95% CI 1:386,000 to 1:13,000) in 1978-82 vs 1:176,000 (95% CI 1:714,000 to 1:46,000) in 1999, a fourfold reduction. In most cases, there were both inadequate practice and systems failure (inappropriate communication between staff, inadequate supervision, poor organisation). This large French survey shows that deaths associated with respiratory complications during anaesthesia have been strikingly reduced during this 15-year period.

Cardiac troponin I release after hip surgery correlates with poor long-term cardiac outcome.

BACKGROUND AND OBJECTIVE: The aim of this study was to assess the incidence of perioperative myocardial damage detected by serial measurements of troponin I after hip surgery and its association with late cardiovascular outcome. METHODS: Troponin I was measured during the first three postoperative days in 88 consecutive patients undergoing hip surgery. Values above the 99th percentile (0.08 ng mL(-1)) were considered positive. Major cardiac events (cardiac death, myocardial infarction and cardiac failure) were recorded during hospital stay and 1 yr after surgery. RESULTS: Eleven patients (12.5%) exhibited elevated troponin I levels during hospital stay. Nine of them remained asymptomatic. During follow-up, 45% of them (5/11) suffered from a major cardiac event vs. 4% (3/76) for patients with normal postoperative troponin I levels (P = 0.0006). All-cause mortality rate was 36% (4/11) at 1 yr vs. 7% (5/71, P = 0.0131). Using multivariate Cox regression analysis adjusted for baseline data, independent factors associated with the occurrence of a cardiac event were troponin I elevation (OR=17.4-CI 95% 3.7-82) and age (OR=1.1 yr(-1)-CI 95% 1.01-1.21). Independent factors for all-cause mortality were troponin I elevation (OR=41.4-CI 95% 5.4-320.4), and age (OR=1.3 yr(-1)-CI 95% 1.1-1.4). CONCLUSION: Troponin I release is common after hip surgery and is associated with a 10-fold increased incidence of long-term major cardiac events as compared to patients with normal troponin I levels (45% vs. 4%).

[Risk analysis of postoperative anemia through biological databases querying]. / Méthode d'analyse du risque d'exposition à l'anémie postopératoire par interrogation des bases de données de biologie.

INTRODUCTION: The assessment of postoperative care relies mainly on spontaneous reporting of major adverse events (MAE). We propose an alternative approach that we have tested on the measurement of the risk of postoperative anemia which is frequentely associated with anaesthethic related deaths. METHODS: The procedure consisted in extracting the electronic sheet generated by the biological analyser and merging it with the anesthesia data base with a filter based on patient's location in the hospital. The orthopedic surgery ward was chosen because of the frequency of full blood count (FBC) associated with the prescription of low weight molecular heparin in this setting. All FBC of the year 2005 were analysed. A risk stratification was achieved according to the conbination of age and depth of anemia. Medical charts of patients exposed to the greatest risk were reviewed. RESULTS: FBC of 691 orthopaedic surgery patients were analysed. Haemoglobin levels (Hb) less than 8g/dl were observed in 41 (5.9%) patients. Two consecutive Hb less than 8g/dl were founded in 18 patients (2.6%), eight (1.2%) charts of patients exposed to the highest risk were reviewed and six cases of no-transfusion or delayed transfusion were identified. CONCLUSION: A global approach to the risk of postoperative anemia but also of MAE related to postoperative haemorrage can be obtained by monitoring electronic databases.

[Safety management and compliance with rules]. / Management des risques et respect des règles.

The design of rules (laws, norms, policies, procedures, protocols) and the implementation of a management that aimed at conforming the behaviors of operators with these rules has long been the dominant approach to improve safety in socio-technical systems. This approach has proven to be effective in enhancing safety by enabling organizations to cope with predictable risks and failures. However, in our modern and constantly evolving socio-technical systems, where the management of unforeseen situation has become the rule, this approach has shown its limitations: operators' initiatives, which sometimes deviate from rules, are equally important for maintaining safety. Therefore, while the rules remain a key feature of risk management, the challenge is not the search for total compliance with rules, but the permanent monitoring of their use to detect and distinguish gaps that constitute a drift towards the accident from gaps that highlight that the rule has become inappropriate and which the compliance with may prove dangerous for safety.

[Epidural anaesthesia and lumbar tattoo: what to do?]. / Analgésie par voie péridurale et tatouage lombaire: que faire?

More and more often, the anaesthesiologist may have to perform lumbar epidural anaesthesia in a patient with a central lumbar tattoo, and this can occur in an urgent obstetric setting. Before managing two uneventful cases of epidural analgesia for labour, we have performed a literature review and noted that no serious complication has been reported. Nonetheless, a needle passed through a tattoo can entrap pigmented tissue fragments (cores) into the epidural or subarachnoid space. This could theoretically induce risk of late neurological complications, related to an inflammatory or granulomatous response to the pigmented cores introduced in these spaces. To avoid this theoretical risk, the anesthesiologist should try to avoid puncturing through the tattoo, either by selecting a different vertebral interspace, or by using a paramedian approach or by finding a pigment free skin spot within the area of the tattoo. When these options cannot be implemented, a superficial skin incision prior to needle insertion should prevent from coring tattoo pigment when entering the skin. Whatever the final choice, the technique to be implemented should be determined as early as the antenatal visit, after informed consent.

Continuous epidural analgesia with bupivacaine 0.125% or bupivacaine 0.0625% plus sufentanil 0.25 microg.mL(-1): a study in singleton breech presentation.

Epidural analgesia is the most efficient technique for labor pain relief. However, its resultant motor block might impair the mode of delivery, particularly in breech presentation where the risk of dystocia is high. In this trial, we compared bupivacaine 0.125% with a combination of a low concentration of bupivacaine (0.0625%) and sufentanil (0.25 microg.mL(-1)) both administered by continuous infusion. Analgesia, maternal and fetal/neonatal side effects and obstetric outcome were compared between group bupivacaine (n = 23) and group bupivacaine-sufentanil (n = 35). A greater number of patients in the bupivacaine 0.125% group required more than two top-ups (32 vs. 8% of patients, P = 0.03) while pain scores were similar. Motor block at delivery was more pronounced in the bupivacaine 0.125% group. Nausea and pruritus were more often encountered in the bupivacaine-sufentanil group. There was a trend toward a decreased rate of assisted or operative delivery in the bupivacaine-sufentanil group (92% vs. 74%, P = 0.09). Fetal/neonatal data did not differ between groups. Epidural analgesia with bupivacaine-sufentanil required fewer additional top-ups and produced less motor block than did bupivacaine 0.125%. However, there was no significant difference in mode of delivery between the two analgesic regimens.

[Intraoperative arterial hypotension recorded by an anaesthesia information management system]. / Utilisation d'une base de recueil des incidents anesthésiques: épidémiologie de l'hypotension artérielle peropératoire.

OBJECTIVES: In order to evaluate the benefits arising from regular recording of intraoperative adverse events, we extracted from our database all episodes of intraoperative hypotension and studied the risk factors of this event. STUDY DESIGN: Retrospective analysis of a large database from two university teaching hospitals evaluating the incidence and the risk factors of intraoperative hypotension by logistic regression. PATIENTS AND METHODS: A data collection chart describing the patient's characteristics, the anaesthetic technique and selected intraoperative incidents was filled for each anaesthetised patient in the operating room and then recorded in the computer database. Data collected in 2001 in patients undergoing general anaesthesia for orthopaedic and general surgery were reviewed and univariate and multivariate analysis were performed using Statview 5.0 and Stata 7.0. RESULTS: Among 11 820 patients who underwent anaesthesia, 2691 were selected. The incidence of intraoperative arterial hypotension was 16.8%. The associated factors were duration of surgery, age and ASA status of the patients. The use of etomidate for induction was not associated with a decreased risk of intraoperative hypotension. CONCLUSION: Systematic recording of intraoperative events in a database has been suggested as useful by many experts for quality-assurance and safety analysis purposes. Analysis of a frequent anaesthesia-related (i.e. hypotension) event did not disclose any relevant factor that might lead to improvement. Running such databases is time-consuming and may be expensive. This leads us to question the efficiency of such databases.

[Factors associated with laparoscopic approach for cholecystectomy, appendicectomy and inguinal herniorraphy in France]. / Facteurs associés à la coelioscopie dans les cholécystectomies, les appendicectomies et les cures de hernie inguinale en France.

OBJECTIVE: To determine on a national level the factors associated with the use of laparoscopy for digestive surgery. STUDY DESIGN: Nation wide study using a large representative sample (3 days of anaesthesia in France). METHODS: Univariate followed by multivariate analyses of data gathered in 1996 during the survey led by the French Society of Anaesthesia and Intensive care ("SFAR") including 2847 surgical procedures for cholecystectomy, appendicectomy or inguinal herniorraphy. RESULTS: Independent factors associated with the use of laparoscopy were: for cholecystectomy: age (less frequent when > or =71 years: adjusted Odds ratio [AOR] 0.4), sex (more frequent in female: AOR 1.7), ASA physical status (less frequent when > or =3: AOR 0.5), private hospital (AOR 2.0), procedure scheduled at least the night before (AOR 2.1), and use of closed circuit general anaesthesia (AOR 1.6); for appendectomy: age >15 years (AOR 1.9-2.2), female (AOR 2.1), private hospital (AOR 2.7), scheduled procedure (AOR 2.1), prolonged procedure (AOR 8.4), endotracheal intubation (AOR 16.7), and closed circuit (AOR 2.7); for inguinal herniorraphy: ASA physical status (less frequent when > or =3: AOR 0.4), private hospital (AOR 3.4), prolonged procedure (AOR 5.6), and endotracheal intubation (AOR 21.6). Association with a closed circuit was confirmed for general anaesthesia using a volatile agent (AOR 1.5). Overall, ambulatory surgery was rarely performed and used only for open procedures. Regional anaesthesia was used only for inguinal open herniorraphy. CONCLUSION: These data obtained from a large national survey confirmed the higher frequency of laparoscopy in middle aged patients, female (except for inguinal herniorraphy), without important comorbidity, in private hospitals. Laparoscopy was associated with prolonged procedures and with a change in the anaesthetic technique for appendicectomy and inguinal herniorraphy: tracheal intubation was almost constantly used. Whatever the procedure, closed circuit anaesthesia was more frequently used when surgery was performed under laparoscopy, reflecting newer equipment of the hospital, private or public.

[Factors associated with blood transfusion during anesthesia for scheduled hip or knee arthroplasty in France]. / Facteurs associés à la stratégie transfusionnelle au cours des anesthésies programmées pour arthroplastie de hanche ou de genou en France.

GOAL OF THE STUDY: To determine over a whole country what are the factors associated with an intraoperative homologous blood transfusion and with the use of autologous techniques (preoperative autologous blood donation: PABD; acute normovolemic hemodilution: ANVH; intraoperative red cell salvage: IRCS). STUDY DESIGN: National enquiry using a large representative sample (3 days of anaesthesia in France). METHODS: Univariate followed by multivariate analyses of data gathered in 1996 during the survey leaded by the French society of anaesthesia and intensive care (Sfar) and corresponding to 884 scheduled hip and knee prosthesis surgical procedures. RESULTS: Factors associated with a decreased use of PABD programme were: 1--old age and high ASA physical status; 2--procedures of short duration. By contrast, an increased use of PABD was associated with anaesthetics in which a closed circuit had been used. Except for a significant association with increasing age and with absence of PABD used, no additional factor was found to be linked with ANVH. No factor among those studied was found related to the use of IRCS. Homologous blood transfusion was more frequently used in ASA > or = 3 patients, in long duration surgeries while its use was decreased in patients with PABD (odds ratio--for reduction by PABD: 4.4 [95% confidence interval: 2.2-8.8]). Homologous blood transfusion was not related to the use of ANVH or IRCS. CONCLUSION: These data obtained from a large national survey confirm previously published studies and meta-analyses and are in agreement with current recommendations. An unexpected relation between PABD and closed circuit anaesthesia has been found.

[Anesthesia in France]. / L'anesthésie en France.

Anaesthesiology is a recent medical speciality, established in 1965, that is formally termed in French Anesthésie-réanimation (Anaesthesiology-intensive care). Since its creation, the discipline has had a range of activity including anaesthesia, intensive care, prehospitalisation emergencies, acute and chronic pain and diverse follow-up. In France 8 million anaesthesias are performed per year, by 8,500 physicians specialised in anaesthesiology, assisted by 7,500 anaesthesiology nurses. It is estimated that each year 13.5% of the French population undergoes anaesthesia, with variations related to sex and age. Over 15 years, the number of anaesthesias performed increased 2.2 fold, due to the increase in certain types of surgery (especially orthopaedics) but also obstetrics (35 times more peridural anaesthesias) and the explosion of GI endoscopy (50 times increase). This increased activity involves patients at the extreme ranges of life, young women and fragile persons. Local and regional anaesthesias represent 21% of those performed, and outpatient anaesthesia is 12 times that of 15 years ago.

[Glucose variability in intensive care unit]. / La variabilité glycémique en réanimation.

Hyperglycemia is significantly associated with increased mortality in critically ill patients and then, strict control of blood glucose (BG) concentration is important. Lowering of BG levels with intensive insulin therapy (IIT) was recommended in order to improve patient outcomes. But recently, some recent prospective trials failed to confirm the initial data, showing conflicting results (significantly increased mortality with IIT, more hypoglycemic episodes). So there is no consensus about efficiency and safety of IIT. Significant associations between glucose variability and mortality have been confirmed by several recent studies. A difference in variability of BG control could explain why the effect of IIT varied from beneficial to harmful. Managing and decreasing this BG variability could be an important goal of BG control in critically ill patients. Clinicians have to consider definitions, physiopathology and impacts of glucose variability, in order to improve patient outcomes.

[Errors of red cell concentrates recipients: method of analysis using the adverse events notified to the hemovigilance network in 2009]. / Erreurs de destinataire de concentrés de globules rouges : méthode d'analyse à partir de déclarations d'incidents de la chaîne transfusionnelle en 2009.

CONTEXT: Among the adverse events in the blood transfusion process, transfusion to a "wrong" patient is potentially dangerous, as it can lead to an adverse reaction at least in case of ABO incompatible red cell concentrate. MATERIAL AND METHODS: The "Root Cause Analysis" working party of the National Hemovigilance Commission developed a tool to collect this type of adverse event, and tested it on a sample of 43 cases involving red cell concentrates notified between March, 2009 and February, 2010. RESULTS: One hundred and nine failures of a step in the transfusion process were observed, i.e. 2.5 failures per adverse event. Failures may occur early in the process. However, they are mainly found at the time of issuing of the blood component, and further, in the clinical ward. How the failure is eventually detected is not always described when the blood component has been fully transfused, in contrast with the cases where actual transfusion to the wrong patient has been prevented. Knowing the way of failure detection enables an objective approach of the efficacy of the numerous existing safety measures. In this sample, bedside controls (documents check as well as the use of anti-A and anti-B reagents with patient's blood and red cell concentrates) detected the failure in three cases out of 34, which were not detected before, showing an efficacy similar to the administrative control done at reception in the clinical ward. CONCLUSION: The document, set up to analyse step by step these cases of patient errors, will be used in the future to analyse all similar cases, not only with red cell concentrates, but also with platelet concentrates and fresh frozen plasma, ultimately in order to improve their prevention.

[Second wave of the French drug harmonisation programme to prevent medication errors: overall appreciation of healthcare professionals]. / Évaluation de l'impact auprès des professionnels de la mise en œuvre de la seconde vague du plan d'harmonisation de l'étiquetage des injectables.

BACKGROUND: Medication errors are a significant cause of severe healthcare-associated complications. In December 2006, the French Health Products Agency (Afssaps) has issued a protocol to harmonise labeling of injectable drugs vials. In 2007, a first change was launched for four drugs and was followed in 2008-2009 by a second wave concerning 42 active drugs. METHODS: The present study describes how healthcare professionals have perceived this change and their overall appreciation of the drug harmonisation programme. A survey using an electronic questionnaire was distributed to medical and non-medical professionals in anaesthesia and intensive care and pharmacists in a representative sample of 200 French hospitals. RESULTS: The harmonisation procedure was felt as being overall satisfactory by 53% of professionals who had responded but it was recognised that the new procedure is associated with improved readability and understanding of drug dosage. The use of colour coding was also well accepted by the personnel of clinical units. Respondents expressed significant criticisms regarding both the communication plan and the way the plan was implemented locally in hospitals. Old and new labeling coexisted in 66% of responding hospitals and many respondents described being aware of errors or near-misses that were considered related to the transition. For many important topics, pharmacists had views that were significantly different from clinicians. CONCLUSION: This national survey describing the perception of healthcare professionals regarding the new harmonisation procedure for injectable drugs highlighted some progress but also a number of deficiencies, notably regarding communication and implementation of the change in clinical units. This survey will be used by the French Health Products Agency to improve future steps of the long-lasting campaign against medication errors.

[Epidemiology of war injuries, about two conflicts: Iraq and Afghanistan]. / Type et épidémiologie des blessures de guerre, à propos de deux conflits actuels : Irak et Afghanistan.

Since March 2003, military operations in Iraq "Operation Iraqi Freedom" (OIF) and in Afghanistan "Operation Enduring Freedom" (OEF), have made many wounded and killed in action (KIA). This article proposes to highlight the specific epidemiology of combat casualties, met in these both non-conventional and asymmetric conflicts. Personal protective equipments, Kevlar helmet and body armor, proved their efficiency in changing features of war injuries. Health Force Services organized trauma care system in different levels, with three main objectives: immediate basic medical care in battalion aid station, forward surgery and early aeromedical evacuation. The Joint Theater Trauma Registry (JTTR), a war injury registry, provides medical data, analyzed from the combat theater to the military hospital in United States. This analysis concluded that during modern conflicts, most injuries are caused by explosive devices; injuries are more severe and interestingly more specifically the head region and extremities than the trunk. Hemorrhage is the first cause of death, leading to the concept of avoidable death. Specific databases focused on mechanisms and severity of injuries, diagnostic and treatment difficulties, outcomes can guide research programs to improve war injuries prevention and treatment.