Adverse events during nursing care procedure in intensive care unit: The PREVENIR study.

OBJECTIVES: Intensive care unit patients undergo several nursing care procedures (NCP) every day. These procedures involve a risk for adverse events (AE). Yet, their prevalence, intensity, and predisposing risk factors remain poorly established. The main objective of the study was to measure the incidence and severity of NCP related AE. DESIGN: This prospective observational multicentre study was conducted in 9 ICUs. All NCP were recorded for four consecutive weeks. For each NCP, the following were collected: patients' baseline characteristics, type of NCP, characteristics of the NCP, AE and therapeutic responses. RESULTS: 5849 NCP occurred in 340 patients. Among the 340 patients included, 292 (85.9%) were affected by at least one AE, and 141 (41.5%) by an SAE during a NCP. Thirty % of NCP were associated with at least one AE: hemodynamic AE in 17.1%, respiratory AE in 13.6%, agitation and pain (3.7% and 3.3%). Eight invasive devices were accidentally removed. Severe Adverse Events (SAE) occurred in 5.5% of NCP. The main risk factor associated with SAE was pain/agitation at the beginning of the NCP. CONCLUSION: AE are frequent during NCP in ICU. We identified several risk factors, some of them preventable, that could be considered for the development of recommendations for the nursing care of critically ill patients. TRIAL REGISTRATION: ClinicalTrials.gov NCT02881645.

Silver absorption and toxicity evaluation of silver wound dressings in 40 patients with chronic wounds.

BACKGROUND: Silver-containing dressings are considered to be safe even though there have been some reports of complications, including argyria and various organ system dysfunctions. Despite the widespread use of silver dressings, little research has been done regarding the absorption and toxicity of silver. OBJECTIVE: We aimed to study the systemic absorption of silver in patients with chronic inflammatory wounds and to determine associated factors of systemic silver absorption and evaluated its association with silver toxicity. PATIENTS AND METHOD: Prospective, longitudinal, observational, multicentre, open-label pilot study. Patients from the Dermatology Departments of Lorraine (France) with the following inclusion criteria: (i) a chronic wound of more than 6 weeks and (ii) an ulcer needing silver-containing dressing were included. Before and after 28 days of treatment, clinical characteristics of the wound were recorded; hemogram, hepatic and renal functions, albumin sera and serum silver level were measured. RESULTS: Half of the cases displayed raised levels of silver after 1 month of treatment. Predictive factors for systemic silver absorption were wound area, anaemia and malnutrition with anaemia and malnutrition confirmed on multivariate analysis. Wound vascularization may also play a role, as a higher absorption was observed in cases of wound granulation without arterial components. No toxicity was detected. This work has also emphasized the slow elimination of silver from the body. CONCLUSION: Both long-term application and iterative treatments with silver dressings should be discouraged, especially in the elderly, who often suffer from malnutrition and anaemia to avoid potential cumulative toxicity.

Neuromuscular blocking agents induced anaphylaxis: Results and trends of a French pharmacovigilance survey from 2000 to 2012.

BACKGROUND: Perioperative anaphylaxis mainly involves neuromuscular blocking agents (NMBAs) with an IgE-mediated mechanism. In France, this life-threatening condition is reported by anesthetists and allergologists, and two safety alerts concerning suxamethonium were raised in 2011 and 2012. This led to start a national survey over the 2000-2012 period which objectives were to provide a descriptive analysis, to estimate incidence rates, and to analyze the trends over this period. METHODS: The French pharmacovigilance database was retrospectively queried for all the available NMBAs. Anaphylaxis cases with elevated tryptase and positive skin tests were qualified as "confirmed cases." Subgroup analysis compared atracurium and cisatracurium vs suxamethonium and rocuronium. RESULTS: A total of 680 confirmed cases and 944 nonconfirmed cases were identified. Suxamethonium was the most implied NMBA (64%). Incidence rates (according to sales data) of suxamethonium and rocuronium were, respectively, 10- and 13-folds higher than those of the others NMBAs, regardless the confirmed/nonconfirmed status. Cisatracurium incidence rates remained stable over the period, while suxamethonium and atracurium increased and rocuronium first decreased but re-increased after 2006. Male patients were more frequent in the subgroup "atracurium-cisatracurium" (P = .019), whereas obesity and emergency setting were more frequent in the subgroup "rocuronium-suxamethonium." Shared characteristics were the poorly documented previous exposure to NMBA(s) and an insufficient adherence of patients to perform skin tests, showing the need to improve this procedure. CONCLUSION: Suxamethonium and rocuronium are markedly more involved in perioperative anaphylaxis than the other available NMBAs. Patients should be more informed about their perioperative anaphylaxis and its consequences.

[Intracranial hemorrhage and oral anticoagulants of patients treated between 2011 and 2013 at the Nancy Regional University Hospital]. / Hémorragies intracrâniennes et anticoagulantes orales de patients traités entre 2011 à 2013. Étude descriptive au CHRU de Nancy.

OBJECTIVE: To perform a descriptive analysis of intracranial hemorrhages of patients treated with an antivitamin K (fluindione, acenocoumarol or warfarin) or a direct oral anticoagulant (dabigatran, rivaroxaban or apixaban) at the Nancy Regional University Hospital. MATERIAL AND METHOD: The study period was from January 2011 to December 2013 and the computerized data (Programme de Médicalisation des Systèmes d'Information) of our hospital was accessed to identify the patients. Clinical data were obtained from the patients' files. Regional healthcare system was queried for reimbursement data. RESULTS: Among the 157 identified cases of intracranial hemorrhage, 153 were related to antivitamin K, primarily fluindione (n=127), and only 4 to a direct oral anticoagulant (3 dabigatran and 1 rivaroxaban). During the same period, regional data indicated that 65,345 patients had had at least one reimbursement of antivitamin K and 20,983 patients one reimbursement of an oral direct anticoagulant. In our series, the most frequent intracranial hemorrhages were subdural hematoma (chronic in 65 cases, acute in 50 cases) and intraparenchymal hemorrhage (20 cases). The global mortality rate was 20.2% but varied with the site of hemorrhage. In multivariate analysis, the two risk factors of fatal outcome were coma on admission (OR 6.2; 95%CI: 2.6-15.0) and a history of previous intracranial hemorrhage (OR 13,4; 95% CI: 1,6-114,9). CONCLUSION: During the 2011-2013 period, antivitamin K, especially fluindione, was the most frequently involved anticoagulants in intracranial hemorrhages with hospitalization at our Regional University Hospital. Coma on admission and a history of previous intracranial hemorrhage were the two main risk factors for fatal outcome.

Fatal anaphylaxis with neuromuscular blocking agents: a risk factor and management analysis.

BACKGROUND: Anaphylactic reactions to neuromuscular blocking agents (NMBAs) can be severe and even fatal. Our aim was to evaluate mortality rate in France from anaphylactic reactions to NMBAs, to identify risk factors for a fatal outcome, and to describe management of the cases that proved fatal. METHODS: The French National Pharmacovigilance Database was queried for reports of NMBA anaphylaxis that occurred between January 2000 and December 2011. A questionnaire was sent to regional pharmacovigilance centers to obtain further information on the management of cases with a fatal outcome. RESULTS: Two thousand and twenty-two cases of NMBA hypersensitivity were retrieved, of which 84 were fatal (4.1%). Among the 1247 cases of severe NMBA anaphylaxis (grades 3 and 4), independent risk factors associated with a fatal outcome in a multivariate analysis were male gender (female gender: OR = 0.4; 95% CI 0.2-0.7; P = 0.0004), an emergency setting (OR = 2.6; 95% CI 1.5-4.6; P = 0.0007), a history of hypertension (OR = 2.5; 95% CI 1.5-4.4; P = 0.0010) or of other cardiovascular disease (OR = 4.4; 95% CI 2.4-8.1; P < 0.0001), obesity (OR = 2.4; 95% CI 1.1-5.3; P = 0.0376), and ongoing beta-blocker treatment (OR = 4.2; 95% CI 1.8-9.8; P = 0.0011). All 31 patients with a fatal outcome received epinephrine in a titrated manner according to international guidelines. CONCLUSION: Obese males with a history of cardiovascular disease receiving ongoing beta-blocker treatment and undergoing surgery in an emergency setting were at high risk of a fatal outcome after NMBA-induced anaphylaxis. Some epinephrine-resistant cases may play a role in our high mortality rate. New therapeutic approaches need to be developed to treat these cases.

[Changes in the European baseline series from 1981 to 2011 in a French dermatology-allergology centre]. / Évolution de la batterie standard européenne de 1981 à 2011 dans un centre de dermato-allergologie français.

BACKGROUND: Periodically updated, the European baseline series (EBS), first introduced in France in 1980, is an indispensable tool for the exploration of contact allergy. The aim of our study was to describe the prevalence of contact sensitization in a French centre between 1981 and 2011 to determine whether certain allergens may be deleted from the current BSE. PATIENTS, MATERIALS AND METHODS: A retrospective study was conducted in a department of dermatology-allergology to analyse the results of all EBS tests performed every 10 years, from 1981 to 2001, and annually from 2007 to 2011. Some added allergens, introduced in 2010, were also studied. Changes in allergen positivity were analysed using a Cochran-Armitage test. RESULTS: Among the 4551 patients included for the 8-year period studied, the prevalence of positivity was 42.91%. The most common allergens in the general population were nickel sulphate (17.25%), with a constantly increasing prevalence, Myroxylon pereirae (10.68%), fragrance mix I (8.11%), cobalt chloride (6.99%) and chromium (6.33%). The least frequent sensitizations, with a decreasing prevalence, were found with clioquinol (0.25%), primin (0.54%) and benzocaine (0.55%). CONCLUSION: Due to modifications in exposure to allergens, the incidence of contact sensitization can change, but nickel sulphate sensitization is increasing despite recent European directives. Allergens with less than 1% of positive results could be withdrawn from the EBS, with benzalkonium chloride, methylisothiazolinone and lavender absolute being added.

[Comparative results of macular hole surgery with and without internal limiting membrane staining with Brilliant Blue G]. / Résultats comparatifs de la chirurgie des trous maculaires opérés avec et sans coloration de limitante interne par le Brilliant Blue G.

OBJECTIVE: To evaluate the role of Brilliant Blue G (BBG) in macular hole (MH) surgery. METHODS: Comparative retrospective study between two groups of 20 consecutive patients who underwent macular hole surgery. In the first group (G1), the inner limiting membrane (ILM) was systematically peeled without staining, while in the second group (G2), BBG was consistently utilized. Pre- and postoperative logMAR visual acuities (VA) were studied, as well as macular optical coherence tomography (OCT) scans to measure MH size, to confirm postoperative closure and to evaluate the integrity of the IS/OS junction. Time required and difficulty of peeling were compared between the two groups. Minimum follow-up was six months. RESULTS: After six months follow-up, the average improvement in acuity was 0.56±0.48 logMAR for G1, versus 0.60±0.44 logMAR for G2 (P=0.80). The rate of closure after one surgery was 85% (17/20 patients) for G1, versus 95% (19/20 patients) for G2 (P=0.29). Postoperative OCT appearance of the IS/OS junction was similar in both groups: intact in 16/20 patients (80%), disrupted in 3/20 patients (15%), and indeterminate in 1/20 patients (5%) (P=1). The mean duration of peeling in G1 was 270.9±27.4 seconds. It was deemed difficult in ten eyes and incomplete in two patients, while in the G2 group, the mean duration of ILM peeling was 140.8±37.6 seconds (P<0.01); it was deemed complete and technically easy in all cases. CONCLUSION: The use of BBG was effective in facilitating and accelerating ILM peeling during MH surgery. The anatomical and functional results were not statistically better in the group that received BBG.

Usefulness of the script concordance test in dermatology.

BACKGROUND: The script concordance test (SCT) measures clinical data interpretation in the context of uncertainty. To our knowledge, its feasibility has not yet been demonstrated in dermatology. OBJECTIVES: This study describes the feasibility, reliability and validity of the SCT for use in dermatology teaching to family medicine residents. METHODS: We designed an SCT for dermatology teaching, adapted to the level of family medicine students. The family medicine residents attending a dermatology lecture course and a reference panel of dermatologists underwent the test. Software available on the SCT-dedicated website was used to determine the scores. The Cronbach's α was calculated. The scores were described by means, standard deviation, and minimum and maximum scores. Mann-Whitney tests were used to compare resident and reference panel scores. RESULTS: The test contained 33 vignettes of four questions each. Cronbach's α was 0.80. Mean scores were 75.6 for the reference panel and 65.0 for the residents (P = 0.0009). CONCLUSIONS: This study confirmed the SCT's capacity to distinguish groups on the basis of experience. This study demonstrated the feasibility and reliability of the SCT in the field of dermatology.

Keloids treated with postoperative Iridium 192* brachytherapy: a retrospective study.

BACKGROUND: Post-excisional brachytherapy with Iridium 192 is a treatment of keloids scars (KS). Its indications and its parameters are not subject to any consensus. OBJECTIVE: We wanted to assess the effectiveness and satisfaction of patients treated in our centre. PATIENTS AND METHODS: This was a retrospective study conducted from November 2006 to November 2007. Patients with clinically and histologically proven KS treated between 1990 and 2005, were convened in consultation between September and October 2007. Clinical data and parameters of the brachytherapy have been collected. RESULTS: Eighty-seven patients (138 KS) were treated. Eighty-two KS (46 patients) met the criteria for inclusion. Thirty-two patients (55 KS) have been seen in consultation. The average time between the onset of KS and treatment was 63.5 months. The brachytherapy has begun after a maximum of 7 hours posterior to surgery for all KS. The average dose was 17.9 Gy calculated at 5 mm. We observed 23.6% of recurrence after treatment. Seventy-nine per cent of itching and 87.5% of pain have totally disappeared. The phototypes 5 and 6 had an increased risk of recurrence. DISCUSSION: This is the most important series of KS treated with Post-excisional brachytherapy presented so far. The technique is efficient in preventing keloid recurrence and in treating the functional signs, but at the expense of an unaesthetic result, of which patient must be warned about. A follow-up of at least two years after treatment is recommended.