Strategy to secure the neuraxial route in anaesthesia: Risk mapping and feedback from the application of the ISO 80369-6 standard NRFit® connectors.

INTRODUCTION: In anesthesia, a medication error would occur every 20 to 133 anesthesia procedures, and 14% is related to a route administration error. To secure neuraxial route, ISO group published a norm in 2016 to develop specific connectors, the "NRFit® connector". The main objective of this work, is to develop a risk mapping related to neuraxial medication errors therefore prepare the NRFit® implementation in anesthesia units in a French Universitary Hospital. METHODS: Failure modes, effects and criticality analysis (FMECA) methodology was used for our risk mapping which was divided in 3 anesthesia specialities. For each, the analysis was performed for accidental neuraxial administration of intravenous drugs, and its opposite error. Secondly, NRFit® devices were tested for 1 month by 3 experimented anesthetists. RESULTS: The majority of reported errors concerns epidural and intrathecal anesthesia, and more frequently in the field of obstetrics. Opioids and tranexamic acid, administered in neuraxial route, are drugs with the highest criticality. The tests were rather conclusive and made it possible to highlight the additional needs in medical devices. DISCUSSION: Obstetrics is the riskiest area due to the frequency of epidural anesthesia, the administration of critical drugs in intravenous and neuraxial route. This work increased the awareness of our group, improved the measure of this risk and harmonized practices. CONCLUSION: This work is the first step of the project to prevent administration route error in anesthesia during patient's drug management. The next step will be the NRFit® implementation for epidural and combined spinal-epidural anesthesia in our hospital.

Guidelines for reducing the environmental impact of general anaesthesia.

OBJECTIVE: To provide guidelines for reducing the environmental impact of general anaesthesia. DESIGN: A committee of ten experts from SFAR and SF2H and SFPC learned societies was set up. A policy of declaration of competing interests was applied and observed throughout the guideline-writing process. Likewise, it did not benefit from any funding from a company marketing a health product (drug or medical device). The committee followed the GRADE® method (Grading of Recommendations Assessment, Development and Evaluation) to assess the quality of the evidence on which the recommendations were based. METHODS: We aimed to formulate recommendations according to the GRADE® methodology for three different fields: anaesthesia vapours and gases; intravenous drugs; medical devices and the working environment. Each question was formulated according to the PICO format (Population, Intervention, Comparator, Outcome). The literature review and recommendations were formulated according to the GRADE® methodology. RESULTS: The experts' work on the synthesis and application of the GRADE® method led to the formulation of 17 recommendations. Since the GRADE® method could not be entirely applied to all of the questions, some of the recommendations were formulated as expert opinions. CONCLUSION: Based on strong agreement between experts, we produced 17 recommendations designed to guide reducing the environmental impact of general anaesthesia.

Vascular access unit: Six-years experience report in France.

BACKGROUND: The role of nurses in peripherally inserted central catheters (PICC) placement has been limited in France. Having a fully trained nurse-led PICC team can positively impact nursing profession and make better use of valuable human and economic healthcare resources. It can also improve the standards of patient's care, procedural experience, and safety. AIM: The aim of this article is to report the successful outcomes of nurse-led PICC team performed over a 6-year period from a single central hospital in France. METHODS: The authors reviewed all PICCs insertions performed by their trained nurse led team between 2014 and 2019. All quantitative and qualitative variables were considered: the patients admitted, the type of PICC inserted, overall procedural time, the mentor's help, the insert failures, the number of punctures required, the procedural pain utilizing Visual Analog Scale (VAS), any procedural complications, chest X-rays needed, the follow up to the eighth day (D8). RESULTS: From 2014 to 2019, 12,687 PICC were inserted with 128 failed procedures (1%). In 2019, 73% of procedural insertion time was less than 10 min. The request of support rapidly decreased to 2 calls/month. More than 90% of procedures were associated with mild pain (VAS ⩽ 3). After the first month of training, 81% of all procedures were performed with a single insertion puncture. Accidental artery puncture during procedure was 0.5%. The authors found room for improvement, progressing from 97% in the first year to 99% in 2019. Furthermore, the authors found that only 1.85% of all catheters developed local infection within D8, and only 0.83% evolved in vein thrombosis. Total bloodstream infection was at 0.1%. CONCLUSION: The authors report successful outcomes from data collected during the 6-year period demonstrating clear benefits of a nurse-led vascular access team with regard to system wide efficiencies and patient satisfaction.

[Drug-drug interactions and physicochemical incompatibilities during acute phase after allo-SCT: Guidelines from the SFGM-TC]. / Interactions médicamenteuses et incompatibilités physico-chimiques en phase aiguë post-allogreffe : quelle influence des médicaments de support ? Recommandations de la SFGM-TC.

Since patients require multiple intravenous drugs, drug incompatibilities and drug interactions are frequent during the acute phase following hematopoietic cell transplantation. The risk of drug-drug interactions is increased in patients with several comorbidities. The goal of this workshop was to learn how to mitigate the risks of drug incompatibilities and interactions when their usage is therapeutically warranted. Our focus was on proton pump inhibitors and antiemetic drugs as they are routinely used in hematopoietic transplants and frequently lead to incompatibilities and interactions with other drugs such as immunosuppressives and antimicrobials. Routine procedures in transplantation such as the choice of vascular access devices, the setting of infusion lines, the scheduling of administration of drugs and their dilution volumes can be effective armaments to mitigate the risks of drug incompatibilities and interactions. In addition, a multidisciplinary concertation between clinicians, pharmacists and nurses is a key point in the success of patient's care.

Clinical and Organizational Impact of the AIRSEAL® Insufflation System During Laparoscopic Surgery: A Systematic Review.

Several low-impact laparoscopic strategies have been developed to improve the safety of pneumoperitoneum. We conducted a systematic review to establish the current evidence base for the use of the AIRSEAL® insufflation device for low-pressure pneumoperitoneum in laparoscopic surgery. We searched the literature using several electronic databases, for studies with comparative design published in the English language from January 2010 to April 2020. The population of interest included patients with any type of health condition who underwent laparoscopic surgery using the AIRSEAL® insufflation system or a standard CO2 insufflator. Ten studies (four randomized clinical trials/six non-randomized clinical trials), that enrolled 1394 participants in total who underwent urology, gynaecology or abdominal surgeries, were included. Total complication rates were similar between groups. Only three studies evaluated the impact of the insufflation system on post-operative pain, and showed inconsistent benefit of AIRSEAL® (significant decrease in pain in two studies, no difference in one). The same was observed in the two sole studies in which pain killers consumption was measured (significant decrease in morphine consumption 24 h after surgery in one study, no difference in the other). Operative duration was significantly shorter with AIRSEAL® in three studies. For both post-operative room and total length of stay, there was no difference between groups. No studies reported economic outcomes. Current literature supports the feasibility of the AIRSEAL® system during laparoscopic surgery but more studies are required to establish the added clinical benefit and to explore the preferences of physicians and patients.

First Outcomes of the ZSI 475 FtM, a Specific Prosthesis Designed for Phalloplasty.

INTRODUCTION: The ZSI 475FtM is a new prosthesis that has recently been specifically designed for phalloplasty. It has several functions that have been conceived to answer the challenges of implantation after phalloplasty: a large base for pubic bone fixation, realistically shaped hard glans, and a pump shaped like a testicle. AIM: To assess the safety, feasibility, and patient satisfaction of the ZSI 475 FtM. METHODS: Surgical outcomes were analyzed after implantation of the prosthesis between June 2016 and September 2017 (single institution, single surgeon). Patients were then asked to answer a satisfaction questionnaire that included the International Index of Erectile Function-5, Erectile Dysfunction Inventory of Treatment Satisfaction, and Self-Esteem and Relationship, as well as other non-validated questions. MAIN OUTCOME MEASURE: Complication rates and the scores of the different questionnaires were reviewed. RESULTS: 20 patients who had gender dysphoria and underwent operation for a female-to-male procedure were included. The mean age was 37.9 years. Complications after 21 implantations included 2 (9.5%) infections that were medically treated (Clavien II), 1 (4.7%) infection treated by explantation (Clavien IIIb), 2 (9.5%) mechanical failures (Clavien IIIb), and 1 (4.7%) malpositioning (Clavien IIIb). The mean follow-up was 8.9 months (SD 4.0), with 50% of the implanted patients having >12 months of follow-up. 14 patients (70%) answered the satisfaction questionnaire. 12 patients (85.7%) had regular penetrative sexual intercourse. The mean International Index of Erectile Function-5 score was 20.2 of 25 (standard deviation [SD] 7.9), the mean Self-Esteem and Relationship score was 84.5 of 100 (SD 9.9), and the mean Erectile Dysfunction Inventory of Treatment Satisfaction score was 82 of 100 (SD 17.5). 13 patients (92.8%) were satisfied or very satisfied with the prosthesis. CLINICAL IMPLICATIONS: This new innovative prosthesis could better answer the challenges faced by the implantation of an erectile device by phalloplasty. STRENGTH & LIMITATIONS: Our study is the first to report data on this new prosthesis. The main limitation is the small number of patients and the short follow-up. CONCLUSION: Preliminary results for the ZSI 475 FtM are encouraging. Safety seems to be satisfactory, and patient satisfaction is high. Long-term studies are needed for further analysis. Neuville P, Morel-Journel N, Cabelguenne D, et al. First Outcomes of the ZSI 475 FtM, a Specific Prosthesis Designed for Phalloplasty. J Sex Med 2019;16:316-322.

Drug incompatibilities in intravenous therapy: evaluation and proposition of preventive tools in intensive care and hematology units.

PURPOSE: Physicochemical incompatibility (PCI) between drugs infused together is frequent, but under-recognized. PCI can lead to drug inactivity, catheter occlusion, embolism or inflammatory reactions. The aims of this work were to identify most frequent and relevant drug incompatibilities and to review and develop strategies for their prevention. METHOD: This was an observational prospective survey conducted between January and March 2015 in an intensive care unit (ICU) and in September 2014 in a hematology sterile unit (HSU). Drugs administered to patients were recorded and their compatibility assessed based on published compatibility data. RESULTS: Drug incompatibilities accounted for 12% (23/189) and 17% (116/686) of drug pairs infused in the ICU and the HSU, respectively. Pantoprazole was the most frequent drug implied in PCI. Regarding drug classes, anti-infective agents and gastrointestinal drugs were the most frequently implied. Among the incompatible pairs, 78% and 61% implicated a drug with extreme pH in the ICU and HSU, respectively. The tools proposed to reduce the frequency of PCI included: compatibility cross-tables, labeling of drugs with extreme pH and optimized administration schedules. CONCLUSIONS: Given the frequency and the potential for severe consequences of PCI, pharmacists have a role to play in raising awareness of nurses and practitioners, and proposing adequate tools and solutions to reduce their incidence.

Multicentric initial experience with the use of the pressurized intraperitoneal aerosol chemotherapy (PIPAC) in the management of unresectable peritoneal carcinomatosis.

BACKGROUND: PIPAC is a recent approach for intraperitoneal chemotherapy with promising results for patients with peritoneal carcinomatosis (PC). We aimed to evaluate the postoperative outcome of PIPAC in patients with non-resectable PC during our initial experience of the technique. METHODS: All patients who underwent PIPAC for non-resectable PC in three centers were analyzed regarding postoperative outcomes. RESULTS: Seventy-three patients underwent 164 PIPAC. PC was from colorectal, gastric, ovarian, malignant mesothelioma, pseudomyxoma peritonei or other origins in 20, 26, 13, 8, 1 and 5 patients respectively. Forty-five (62%), 31 (42%), 8 (11%), 6 (8%), 1 (1%) patients underwent a second, third, fourth, fifth, and sixth PIPAC respectively. At the time of the first PIPAC, the median PCI was 17 (1-39), 57 patients presented with symptomatic PC (pain: 33; ascites: 35; transit disorder like diarrhea and constipation: 11). PCI improved in 64.5% of patients, 63.5% of patients presented with complete disappearance of symptoms. Major complications occurred as the outcome of 16 PIPAC (9.7%) and 5 (6.8%) patients died within 30 days of the PIPAC procedure. Rate of mortality and major complications 40% and 62% respectively occurred in first 20 treated patients. For 64 (88%) patients, systemic chemotherapy was associated with PIPAC and could be administered after PIPAC with a median delay of 14 days (2-28). CONCLUSIONS: Implementing a PIPAC program in association with systemic chemotherapy is feasible and is associated with a risk of postoperative morbidity, even in teams highly experienced in PC management and requires a learning curve in patient selection.

[IV drug perfusions: safety principles]. / Perfusions IV de médicaments : principes de sécurisation.

An intravenous perfusion is a procedure which comprises infection and medication risks. To manage these risks, caregivers must respect, in addition to the usual hygiene rules, a series of best practices, ensuring the proper use and management of the medical devices and administered drugs.

Sleep Disorders and Therapeutic Management: A Survey in a French Population of Prisoners.

In a French prison, most inmates reported not being satisfied with their sleep. Life habits between good and bad sleepers were not significantly different except for television and smoking. The most frequently reported symptom of insomnia was several awakenings at night, and the most frequently cited etiologies were rumination of thoughts and noise. Most patients reported that their sleeping problems began or worsened after incarceration. A quarter of the inmates were following a hypnotic treatment, and most of these treatments began in prison. Only 42% of patients were satisfied with its effectiveness. These observations enabled us to make recommendations for healthy sleep patterns such as respecting normal night-and-day cycles, encouraging to stop smoking, and promoting appropriate use of hypnotic treatments.

Impact of pharmacist and clinician dual intervention on prescribed benzodiazepines in prisoner patients: a retrospective study.

High-dose benzodiazepine (BDZs) represents an important risk factor for dependence, particularly in a prison environment. In Lyon's prison, BDZs and/or opioid maintenance treatment are often prescribed to patients with mental disorders. The aim of this retrospective study was to assess the impact of psychiatrist and pharmacist collaboration on reducing the BDZs dose prescribed to prisoner patients. Since 2001, clinicians and pharmacists have been holding monthly meetings to develop prescribing guidelines and discuss those patients receiving high-dose BDZs. All prescribed psychotropic drugs were noted for each included patient in the control (before guidelines) and intervention groups. Criteria used to define each patient profile included age, diagnosis (mental disorder), and concomitant treatment (opioids, antidepressants). To compare each group, the daily dose of prescribed BDZs was used as a quantitative variable and expressed in diazepam equivalent. Four hundred and seventy-three patients were included, 222 in the control group and 251 in the intervention group. The two groups showed no difference in terms of diagnosis. The daily dose of BDZ was higher in the control group when all patients were considered (mean(CONTROL GROUP) = 46 mg in diazepam equivalent vs. mean(INTERVENTIION GROUP) = 34 mg) and for each of the following patient categories: 'mental disorder' (48 mg vs. 30 mg), 'no opioid treatment' (44 mg vs. 31 mg), 'buprenorphin treatment' (58 mg vs. 63 mg), 'no antidepressant treatment' (41 mg vs. 29 mg), and 'antidepressant treatment' (53 mg vs. 38 mg). The results of this retrospective study show the positive impact of multidisciplinary intervention on reducing the prescribed daily dose of BDZs. This experience confirms the positive impact that pharmacist feedback on prescriptions and the development of treatment guidelines by clinician and pharmacist collaboration have on improving the prescribing practice in a prison environment.