Development and validation of an assessment tool for adult simulated ultrasound-guided fascia iliaca block: a prospective monocentric study.

BACKGROUND: Fascia iliaca block (FIB) is an effective technique for analgesia. While FIB using ultrasound is preferred, there is no current standardised training technique or assessment scale. We aimed to create a valid and reliable tool to assess ultrasound-guided FIB. METHOD: This prospective observational study was conducted in the ABS-Lab simulation centre, University of Poitiers, France between 26-29 October and 14-17 December 2021. Psychometric testing included validity analysis and reliability between two independent observers. Content validity was established using the Delphi method. Three rounds of feedback were required to reach consensus. To validate the scale, 26 residents and 24 emergency physicians performed a simulated FIB on SIMLIFE, a simulator using a pulsated, revascularised and reventilated cadaver. Validity was tested using Cronbach's α coefficient for internal consistency. Comparative and Spearman's correlation analysis was performed to determine whether the scale discriminated by learner experience with FIB and professional status. Reliability was analysed using the intraclass correlation (ICC) coefficient and a correlation score using linear regression (R2). RESULTS: The final 30-item scale had 8 parts scoring 30 points: patient positioning, preparation of aseptic and tools, anatomical and ultrasound identification, local anaesthesia, needle insertion, injection, final ultrasound control and signs of local anaesthetic systemic toxicity. Psychometric characteristics were as follows: Cronbach's α was 0.83, ICC was 0.96 and R2 was 0.91. The performance score was significantly higher for learners with FIB experience compared with those without experience: 26.5 (22.0; 29.0) vs 22.5 (16.0; 26.0), respectively (p=0.02). There was a significant difference between emergency residents' and emergency physicians' scores: 20.5 (17.0; 25.0) vs 27.0 (26.0; 29.0), respectively (p=0.0001). The performance was correlated with clinical experience (Rho=0.858, p<0.0001). CONCLUSION: This assessment scale was found to be valid, reliable and able to identify different levels of experience with ultrasound-guided FIB.

Cost-effectiveness analysis of bundled innovative devices versus standard approach in the prevention of unscheduled peripheral venous catheters removal due to complications in France.

The objective of the study was to perform a cost-effectiveness analysis of bundled devices (BDs) versus standard devices (SDs) for the prevention of unscheduled peripheral venous catheter (PVC) removal due to complication from a French investigator-initiated, open-label, single center, randomized-controlled, two-by-two factorial trial (CLEAN-3 study). A 14-day time non homogeneous semi-markovian model was performed to be fitted to longitudinal individual patient data from CLEAN-3 database. This model includes five health states and eight transitional events; a base case scenario, two scenario analyses and bootstrap sensitivity analyses were performed. The cost-effectiveness criterion was the cost per patient with unscheduled PVC removal avoided. 989 adult (age≥18 years) patients were analyzed to compare the BDs group (494 patients), and the SDs group (495 patients). The assessed intervention was a combination of closed integrated catheters, positive displacement needleless-connectors, disinfecting caps, and single-use prefilled flush syringes compared with the use of open catheters and three-way stopcocks for treatment administration. For the base case scenario, an unscheduled 1st PVC removal before discharge was significantly more frequent in the SDs group (235 patients (47.5%) in the SDs group and 172 patients (34.8%) in the BDs group, p = 0.00006). After adjustment for 1st catheter time, the number of patients with unscheduled PVC removal per day was of 16 (95%CI: 15; 18) patients (out of 100) in the BDs group and of 26 (95%CI: 24; 28) patients (out of 100) in the SDs group. The mean cost per patient (adjusted on catheter-time) was of €144 (95%CI: €135-€154) for patients in the SDs group versus €102 (95%CI: €95-€109) for patients in the BDs group; the mean saving per patient was of €42 (95%CI: €32-€54). As a consequence, the assessed BDs strategy was less costly and more effective than the SDs strategy. Trail registration: CLEAN-3 study is registered with ClinicalTrials.gov, NCT03757143.

Cost-effectiveness analysis of chlorhexidine-alcohol versus povidone iodine-alcohol solution in the prevention of intravascular-catheter-related bloodstream infections in France.

OBJECTIVE: To perform a cost-effectiveness analysis of skin antiseptic solutions (chlorhexidine-alcohol (CHG) versus povidone iodine-alcohol solution (PVI)) for the prevention of intravascular-catheter-related bloodstream infections (CRBSI) in intensive care unit (ICU) in France based on an open-label, multicentre, randomised, controlled trial (CLEAN). DESIGN: A 100-day time semi-markovian model was performed to be fitted to longitudinal individual patient data from CLEAN database. This model includes eight health states and probabilistic sensitivity analyses on cost and effectiveness were performed. Costs of intensive care unit stay are based on a French multicentre study and the cost-effectiveness criterion is the cost per patient with catheter-related bloodstream infection avoided. PATIENTS: 2,349 patients (age≥18 years) were analyzed to compare the 1-time CHG group (CHG-T1, 588 patients), the 4-time CHG group (CHG-T4, 580 patients), the 1-time PVI group (PVI-T1, 587 patients), and the 4-time PVI group (PVI-T4, 594 patients). INTERVENTION: 2% chlorhexidine-70% isopropyl alcohol (chlorhexidine-alcohol) compared to 5% povidone iodine-69% ethanol (povidone iodine-alcohol). RESULTS: The mean cost per alive, discharged or dead patient was of €23,798 (95% confidence interval: €20,584; €34,331), €21,822 (€18,635; €29,701), €24,874 (€21,011; €31,678), and €24,201 (€20,507; €29,136) for CHG-T1, CHG-T4, PVI-T1, and PVI-T4, respectively. The mean number of patients with CRBSI per 1000 patients was of 3.49 (0.42; 12.57), 6.82 (1.86; 17.38), 26.04 (14.64; 42.58), and 23.05 (12.32; 39.09) for CHG-T1, CHG-T4, PVI-T1, and PVI-T4, respectively. In comparison to the 1-time PVI solution, the 1-time CHG solution avoids 22.55 CRBSI /1,000 patients, and saves €1,076 per patient. This saving is not statistically significant at a 0.05 level because of the overlap of 95% confidence intervals for mean costs per patient in each group. Conversely, the difference in effectiveness between the CHG-T1 solution and the PVI-T1 solution is statistically significant. CONCLUSIONS: The CHG-T1 solution is more effective at the same cost than the PVI-T1 solution. CHG-T1, CHG-T4 and PVI-T4 solutions are statistically comparable for cost and effectiveness. This study is based on the data from the RCT from 11 French intensive care units registered with www.clinicaltrials.gov (NCT01629550).