Temporal Trends in the Use of Computed Tomographic Pulmonary Angiography for Suspected Pulmonary Embolism in the Emergency Department : A Retrospective Analysis.

BACKGROUND: Recently, validated clinical decision rules have been developed that avoid unnecessary use of computed tomographic pulmonary angiography (CTPA) in patients with suspected pulmonary embolism (PE) in the emergency department (ED). OBJECTIVE: To measure any resulting change in CTPA use for suspected PE. DESIGN: Retrospective analysis. SETTING: 26 European EDs in 6 countries. PATIENTS: Patients with CTPA performed for suspected PE in the ED during the first 7 days of each odd month between January 2015 and December 2019. MEASUREMENTS: The primary end points were the CTPAs done for suspected PE in the ED and the number of PEs diagnosed in the ED each year adjusted to an annual census of 100 000 ED visits. Temporal trends were estimated using generalized linear mixed regression models. RESULTS: 8970 CTPAs were included (median age, 63 years; 56% female). Statistically significant temporal trends for more frequent use of CTPA (836 per 100 000 ED visits in 2015 vs. 1112 in 2019; P < 0.001), more diagnosed PEs (138 per 100 000 in 2015 vs. 164 in 2019; P = 0.028), a higher proportion of low-risk PEs (annual percent change [APC], 13.8% [95% CI, 2.6% to 30.1%]) with more ambulatory management (APC, 19.3% [CI, 4.1% to 45.1%]), and a lower proportion of intensive care unit admissions (APC, -8.9% [CI, -17.1% to -0.3%]) were observed. LIMITATION: Data were limited to 7 days every 2 months. CONCLUSION: Despite the recent validation of clinical decision rules to limit the use of CTPA, an increase in the CTPA rate along with more diagnosed PEs and especially low-risk PEs were instead observed. PRIMARY FUNDING SOURCE: None specific for this study.

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.

Effect of Noninvasive Airway Management of Comatose Patients With Acute Poisoning: A Randomized Clinical Trial.

Importance: Tracheal intubation is recommended for coma patients and those with severe brain injury, but its use in patients with decreased levels of consciousness from acute poisoning is uncertain. Objective: To determine the effect of intubation withholding vs routine practice on clinical outcomes of comatose patients with acute poisoning and a Glasgow Coma Scale score less than 9. Design, Setting, and Participants: This was a multicenter, randomized trial conducted in 20 emergency departments and 1 intensive care unit (ICU) that included comatose patients with suspected acute poisoning and a Glasgow Coma Scale score less than 9 in France between May 16, 2021, and April 12, 2023, and followed up until May 12, 2023. Intervention: Patients were randomized to undergo conservative airway strategy of intubation withholding vs routine practice. Main Outcomes and Measures: The primary outcome was a hierarchical composite end point of in-hospital death, length of ICU stay, and length of hospital stay. Key secondary outcomes included adverse events resulting from intubation as well as pneumonia within 48 hours. Results: Among the 225 included patients (mean age, 33 years; 38% female), 116 were in the intervention group and 109 in the control group, with respective proportions of intubations of 16% and 58%. No patients died during the in-hospital stay. There was a significant clinical benefit for the primary end point in the intervention group, with a win ratio of 1.85 (95% CI, 1.33 to 2.58). In the intervention group, there was a lower proportion with any adverse event (6% vs 14.7%; absolute risk difference, 8.6% [95% CI, -16.6% to -0.7%]) compared with the control group, and pneumonia occurred in 8 (6.9%) and 16 (14.7%) patients, respectively (absolute risk difference, -7.8% [95% CI, -15.9% to 0.3%]). Conclusions and Relevance: Among comatose patients with suspected acute poisoning, a conservative strategy of withholding intubation was associated with a greater clinical benefit for the composite end point of in-hospital death, length of ICU stay, and length of hospital stay. Trial Registration: ClinicalTrials.gov Identifier: NCT04653597.

Effect of a Diagnostic Strategy Using an Elevated and Age-Adjusted D-Dimer Threshold on Thromboembolic Events in Emergency Department Patients With Suspected Pulmonary Embolism: A Randomized Clinical Trial.

Importance: Uncontrolled studies suggest that pulmonary embolism (PE) can be safely ruled out using the YEARS rule, a diagnostic strategy that uses varying D-dimer thresholds. Objective: To prospectively validate the safety of a strategy that combines the YEARS rule with the pulmonary embolism rule-out criteria (PERC) rule and an age-adjusted D-dimer threshold. Design, Settings, and Participants: A cluster-randomized, crossover, noninferiority trial in 18 emergency departments (EDs) in France and Spain. Patients (N = 1414) who had a low clinical risk of PE not excluded by the PERC rule or a subjective clinical intermediate risk of PE were included from October 2019 to June 2020, and followed up until October 2020. Interventions: Each center was randomized for the sequence of intervention periods. In the intervention period (726 patients), PE was excluded without chest imaging in patients with no YEARS criteria and a D-dimer level less than 1000 ng/mL and in patients with 1 or more YEARS criteria and a D-dimer level less than the age-adjusted threshold (500 ng/mL if age <50 years or age in years × 10 in patients ≥50 years). In the control period (688 patients), PE was excluded without chest imaging if the D-dimer level was less than the age-adjusted threshold. Main Outcomes and Measures: The primary end point was venous thromboembolism (VTE) at 3 months. The noninferiority margin was set at 1.35%. There were 8 secondary end points, including chest imaging, ED length of stay, hospital admission, nonindicated anticoagulation treatment, all-cause death, and all-cause readmission at 3 months. Results: Of the 1414 included patients (mean age, 55 years; 58% female), 1217 (86%) were analyzed in the per-protocol analysis. PE was diagnosed in the ED in 100 patients (7.1%). At 3 months, VTE was diagnosed in 1 patient in the intervention group (0.15% [95% CI, 0.0% to 0.86%]) vs 5 patients in the control group (0.80% [95% CI, 0.26% to 1.86%]) (adjusted difference, -0.64% [1-sided 97.5% CI, -∞ to 0.21%], within the noninferiority margin). Of the 6 analyzed secondary end points, only 2 showed a statistically significant difference in the intervention group compared with the control group: chest imaging (30.4% vs 40.0%; adjusted difference, -8.7% [95% CI, -13.8% to -3.5%]) and ED median length of stay (6 hours [IQR, 4 to 8 hours] vs 6 hours [IQR, 5 to 9 hours]; adjusted difference, -1.6 hours [95% CI, -2.3 to -0.9]). Conclusions and Relevance: Among ED patients with suspected PE, the use of the YEARS rule combined with the age-adjusted D-dimer threshold in PERC-positive patients, compared with a conventional diagnostic strategy, did not result in an inferior rate of thromboembolic events. Trial Registration: ClinicalTrials.gov Identifier: NCT04032769.

High-flow nasal cannula oxygen therapy in acute respiratory failure at Emergency Departments: A systematic review.

OBJECTIVES: The use of high-flow oxygen therapy (HFOT) through nasal cannula for the management of acute respiratory failure at the emergency department (ED) has been only sparsely studied. We conducted a systematic review of randomized-controlled and quasi-experimental studies comparing the early use of HFOT versus conventional oxygen therapy (COT) in patients with acute respiratory failure admitted to EDs. METHODS: A systematic research of literature was carried out for all published control trials comparing HFOT with COT in adult patients admitted in EDs. Eligible data were extracted from Medline, Embase, Pascal, Web of Science and the Cochrane database. The primary outcome was the need for mechanical ventilation, i.e. intubation or non-invasive ventilation as rescue therapy. Secondary outcomes included respiratory rate, dyspnea level, ED length of stay, intubation and mortality. RESULTS: Out of 1829 studies screened, five studies including 673 patients were retained in the analysis (350 patients treated with HFOT and 323 treated with COT). The need for mechanical ventilation was similar in both treatments (RR = 0.75; 95% CI 0.41 to 1.35; P = 0.31; I2 = 16%). Respiratory rate was lower with HFOT (Mean difference (MD) = -3.14 breaths/min; 95% CI = -4.9 to -1.4; P < 0.001; I2 = 39%), whereas sensation of dyspnea did not differ. (MD = -1.04; 95% CI = -2.29 to -0.22; P = 0.08; I2 = 67%). ED length of stay and mortality were similar between groups. CONCLUSION: The early use of HFOT in patients admitted to an ED for acute respiratory failure did not reduce the need for mechanical ventilation as compared to COT. However, HFOT decreased respiratory rate. REGISTRATION: PROSPERO ID CRD42019125696.

Early high-flow nasal cannula oxygen therapy in adults with acute hypoxemic respiratory failure in the ED: A before-after study.

OBJECTIVES: To compare clinical impact after early initiation of high-flow nasal cannula oxygen therapy (HFNC) versus standard oxygen in patients admitted to an emergency department (ED) for acute hypoxemic respiratory failure. METHODS: We performed a prospective before-after study at EDs in two centers including patients with acute hypoxemic respiratory failure defined by a respiratory rate above 25 breaths/min or signs of increased breathing effort under additional oxygen for a pulse oximetry above 92%. Patients with cardiogenic pulmonary edema or exacerbation of chronic lung disease were excluded. All patients were treated with standard oxygen during the first period and with HFNC during the second. The primary outcome was the proportion of patients with improved respiratory failure 1 h after treatment initiation (respiratory rate ≤ 25 breaths/min without signs of increased breathing effort). Dyspnea and blood gases were also assessed. RESULTS: Among the 102 patients included, 48 were treated with standard oxygen and 54 with HFNC. One hour after treatment initiation, patients with HFNC were much more likely to recover from respiratory failure than those treated with standard oxygen: 61% (33 of 54 patients) versus 15% (7 of 48 patients), P < 0.001. They also showed greater improvement in oxygenation (increase in PaO2 was 31 mm Hg [0-67] vs. 9 [-9-36], P = 0.02), and in feeling of breathlessness. CONCLUSIONS: As compared to standard oxygen, patients with acute hypoxemic respiratory failure treated with HFNC at the ED had better oxygenation, less breathlessness and were more likely to show improved respiratory failure 1 h after initiation.

Predictors of 30-day mortality in patients admitted to ED for acute heart failure.

OBJECTIVES: Acute heart failure (AHF) is a leading cause of admission in emergency departments (ED). It is associated with significant in-hospital mortality, suggesting that there is room for improvement of care. Our aims were to investigate clinical patterns, biological characteristics and determinants of 30-day mortality. METHODS: We conducted a single site, retrospective review of adult patients (≥18years) admitted to ED for AHF over a 12-month period. Data collected included demographics, clinical, biological and outcomes data. Epidemiologic data were collected at baseline, and patients were followed up during a 30-day period. RESULTS: There were a total of 322 patients. Mean age was 83.9±9.1years, and 47% of the patients were men. Among them, 59 patients (18.3%) died within 30days of admission to the ED. The following three characteristics were associated with increased mortality: age>85years (OR=1.5[95%CI:0.8-2.7], p=0.01), creatinine clearance <30mL/min (OR=2.6[95%CI:1.4-5], p<0.001) and Nt-proBNP >5000pg/mL (OR=2.2[95%CI:1.2-4], p<0.001). The best Nt-proBNP cut-off value to predict first-day mortality was 9000pg/mL (area under the curve (AUC) [95%CI] of 0.790 [0.634-0.935], p<0.001). For 7-day mortality, it was 7900pg/mL (0.698 [0.578-0.819], p<0.001) and for 30-day mortality, 5000pg/mL (0.667 [0.576-0.758], p<0.001). CONCLUSIONS: Nt-proBNP level on admission, age and creatinine clearance, are predictive of 30-day mortality in adult patients admitted to ED for AHF.

High-flow nasal cannula oxygen therapy versus noninvasive ventilation in acute respiratory failure related to suspected or confirmed acute heart failure: a systematic review with meta-analysis.

The objective of this review is to compare high-flow nasal cannula (HFNC) oxygen (High flow oxygen) and noninvasive ventilation (NIV) for the management of acute respiratory failure secondary to suspected or confirmed acute heart failure (AHF). A comprehensive and relevant literature search of MEDLINE, Web of Science, and the Cochrane Library was conducted using Medical Subject Heading and Free text terms from January 2010 to March 2024. All randomized clinical trials and observational retrospective and prospective studies reporting adult patients with acute respiratory failure due to suspected or confirmed AHF and comparing HFNC to NIV were included. Primary outcome included treatment failure, as a composite outcome including early termination to the allocated treatment, need for in-hospital intubation or mortality, or the definition used in the study for treatment failure if adequate. Secondary outcomes included change in respiratory rate and dyspnea intensity after treatment initiation, patient comfort, invasive mechanical ventilation requirement, and day-30 mortality. Six of the 802 identified studies were selected for final analysis, including 572 patients (221 assigned to high flow and 351 to NIV). Treatment failure rate was 20% and 13% in the high flow oxygen and NIV groups, respectively [estimated odds ratio (OR): 1.7, 95% confidence interval (95% CI): 0.9-3.1] in randomized studies and 34% and 16% in the high flow oxygen and NIV groups, respectively (OR: 3.1, 95% CI: 0.7-13.5), in observational studies. Tracheal intubation requirement was 7% and 5% of patients in the HFNC and NIV groups, respectively (OR: 1.4, 95% CI: 0.5-3.5) in randomized studies, and 20% and 9% in the high flow oxygen and NIV group, respectively (OR: 2.1, 95% CI: 0.5-9.4) in observational studies. Mortality was 13% and 8% in the high flow oxygen and the NIV groups, respectively (OR: 1.8, 95% CI: 0.8-1.1) in randomized studies and 14% and 9% in the high flow oxygen and the NIV groups, respectively (OR: 1.4, 95% CI: 0.5-3.7) in observational studies. Compared with NIV, high flow oxygen was not associated with a higher risk of treatment failure during initial management of patients with acute respiratory failure related to suspected or confirmed AHF.

Insertion site and risk of peripheral intravenous catheter colonization and/or local infection: a post hoc analysis of the CLEAN 3 study including more than 800 catheters.

AIM: Although uncommon, infections associated with peripheral intravenous catheters (PIVCs) may be responsible for severe life-threatening complications and increase healthcare costs. Few data are available on the relationship between PIVC insertion site and risk of infectious complications. METHODS: We performed a post hoc analysis of the CLEAN 3 database, a randomized 2 × 2 factorial study comparing two skin disinfection procedures (2% chlorhexidine-alcohol or 5% povidone iodine-alcohol) and two types of medical devices (innovative or standard) in 989 adults patients requiring PIVC insertion before admission to a medical ward. Insertion sites were grouped into five areas: hand, wrist, forearm, cubital fossa and upper arm. We evaluated the risk of risk of PIVC colonization (i.e., tip culture eluate in broth showing at least one microorganism in a concentration of at least 1000 Colony Forming Units per mL) and/or local infection (i.e., organisms growing from purulent discharge at PIVC insertion site with no evidence of associated bloodstream infection), and the risk of positive PIVC tip culture (i.e., PIVC-tip culture eluate in broth showing at least one microorganism regardless of its amount) using multivariate Cox models. RESULTS: Eight hundred twenty three PIVCs with known insertion site and sent to the laboratory for quantitative culture were included. After adjustment for confounding factors, PIVC insertion at the cubital fossa or wrist was associated with increased risk of PIVC colonization and/or local infection (HR [95% CI], 1.64 [0.92-2.93] and 2.11 [1.08-4.13]) and of positive PIVC tip culture (HR [95% CI], 1.49 [1.02-2.18] and 1.59 [0.98-2.59]). CONCLUSION: PIVC insertion at the wrist or cubital fossa should be avoided whenever possible to reduce the risk of catheter colonization and/or local infection and of positive PIVC tip culture.

High-flow nasal cannula oxygen versus noninvasive ventilation for the management of acute cardiogenic pulmonary edema: a randomized controlled pilot study.

BACKGROUND: Whether high-flow nasal oxygen can improve clinical signs of acute respiratory failure in acute heart failure (AHF) is uncertain. OBJECTIVE: To compare the effect of high-flow oxygen with noninvasive ventilation (NIV) on respiratory rate in patients admitted to an emergency department (ED) for AHF-related acute respiratory failure. DESIGN, SETTINGS AND PARTICIPANTS: Multicenter, randomized pilot study in three French EDs. Adult patients with acute respiratory failure due to suspected AHF were included. Key exclusion criteria were urgent need for intubation, Glasgow Coma Scale <13 points or hemodynamic instability. INTERVENTION: Patients were randomly assigned to receive high-flow oxygen (minimum 50 l/min) or noninvasive bilevel positive pressure ventilation. OUTCOMES MEASURE: The primary outcome was change in respiratory rate within the first hour of treatment and was analyzed with a linear mixed model. Secondary outcomes included changes in pulse oximetry, heart rate, blood pressure, blood gas samples, comfort, treatment failure and mortality. MAIN RESULTS: Among the 145 eligible patients in the three participating centers, 60 patients were included in the analysis [median age 86 (interquartile range (IQR), 90; 92) years]. There was a median respiratory rate of 30.5 (IQR, 28; 33) and 29.5 (IQR, 27; 35) breaths/min in the high-flow oxygen and NIV groups respectively, with a median change of -10 (IQR, -12; -8) with high-flow nasal oxygen and -7 (IQR, -11; -5) breaths/min with NIV [estimated difference -2.6 breaths/min (95% confidence interval (CI), -0.5-5.7), P  = 0.052] at 60 min. There was a median SpO 2 of 95 (IQR, 92; 97) and 96 (IQR, 93; 97) in the high-flow oxygen and NIV groups respectively, with a median change at 60 min of 2 (IQR, 0; 5) with high-flow nasal oxygen and 2 (IQR, -1; 5) % with NIV [estimated difference 0.8% (95% CI, -1.1-2.8), P  = 0.60]. PaO 2 , PaCO 2 and pH did not differ at 1 h between groups, nor did treatment failure, intubation and mortality rates. CONCLUSION: In this pilot study, we did not observe a statistically significant difference in changes in respiratory rate among patients with acute respiratory failure due to AHF and managed with high-flow oxygen or NIV. However, the point estimate and its large confidence interval may suggest a benefit of high-flow oxygen. TRIAL REGISTRATION: NCT04971213 ( https://clinicaltrials.gov ).

Telemedicine in Nursing Home Residents Requiring a Call to an Emergency Medical Communication Center.

OBJECTIVES: To compare the proportion of nursing home residents dispatched to an emergency department (ED) after a call to the emergency medical communication center (EMCC) according to the availability or nonavailability of telemedicine. DESIGN: This prospective, observational trial was conducted in the EMCC and 74 nursing homes in a French county. SETTING AND PARTICIPANTS: All nursing home residents who needed to contact the EMCC between June 2019 and April 2020 were included in the study. We excluded calls notifying the death of a resident, for completing data from a previous call, and for nursing home staff. METHODS: The primary outcome was the proportion of residents dispatched to an ED after their first call to the EMCC. The secondary outcomes were the proportion of second calls, proportion of residents dispatched to an ED after a second call, and proportion of death within 30 days. RESULTS: We included 3103 calls in the final analysis (355 from equipped nursing homes and 2748 from unequipped nursing homes). The proportion of patients dispatched to an ED after the first call was lower among telemedicine-equipped than among telemedicine-unequipped nursing homes (41% vs 50%; odds ratio, 0.71; 95% CI, 0.56-0.90). The proportion of a second call for the same purpose within 72 hours, proportion of dispatching to an ED at the second call, and proportion of deaths within 30 days were similar between the groups. CONCLUSION AND IMPLICATIONS: The use of telemedicine by nursing home residents requiring a call to the EMCC is associated with a reduction in the number of dispatches to an ED without any increase in the number of 72-hour callbacks or 30-day mortality rates.

Protect peripheral intravenous catheters: a study protocol for a randomised controlled trial of a novel antimicrobial dressing for peripheral intravenous catheters (ProP trial).

INTRODUCTION: Peripheral intravenous catheters (PIVCs) are the most commonly used vascular access device in hospitalised patients. Yet PIVCs may be complicated by local or systemic infections leading to increased healthcare costs. Chlorhexidine gluconate (CHG)-impregnated dressings may help reduce PIVC-related infectious complications but have not yet been evaluated. We hypothesise an impregnated CHG transparent dressing, in comparison to standard polyurethane dressing, will be safe, effective and cost-effective in protecting against PIVC-related infectious complications and phlebitis. METHODS AND ANALYSIS: The ProP trial is a multicentre, superiority, randomised clinical and cost-effectiveness trial with internal pilot, conducted across three centres in Australia and France. Patients (adults and children aged ≥6 years) requiring one PIVC for ≥48 hours are eligible. We will exclude patients with emergent PIVCs, known CHG allergy, skin injury at site of insertion or previous trial enrolment. Patients will be randomised to 3M Tegaderm Antimicrobial IV Advanced Securement dressing or standard care group. For the internal pilot, 300 patients will be enrolled to test protocol feasibility (eligibility, recruitment, retention, protocol fidelity, missing data and satisfaction of participants and staff), primary endpoint for internal pilot, assessed by independent data safety monitoring committee. Clinical outcomes will not be reviewed. Following feasibility assessment, the remaining 2624 (1312 per trial arm) patients will be enrolled following the same methods. The primary endpoint is a composite of catheter-related infectious complications and phlebitis. Recruitment began on 3 May 2023. ETHICS AND DISSEMINATION: The protocol was approved by Ouest I ethic committee in France and by The Queensland Children's Hospital Human Research Ethics Committee in Australia. The findings will be disseminated through presentation at scientific conferences and publication in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT05741866.

Effect of the 1-h bundle on mortality in patients with suspected sepsis in the emergency department: a stepped wedge cluster randomized clinical trial.

PURPOSE: The efficacy of the 1-h bundle for emergency department (ED) patients with suspected sepsis, which includes lactate measurement, blood culture, broad-spectrum antibiotics administration, administration of 30 mL/kg crystalloid fluid for hypotension or lactate ≥ 4 mmol/L, remains controversial. METHODS: We carried out a pragmatic stepped-wedge cluster-randomized trial in 23 EDs in France and Spain. Adult patients with Sepsis-3 criteria or a quick sequential organ failure assessment (SOFA) score ≥ 2 or a lactate > 2 mmol/L were eligible. The intervention was the implementation of the 1-h sepsis bundle. The primary outcome was in-hospital mortality truncated at 28 days. Secondary outcomes included volume of fluid resuscitation at 24 h, acute heart failure at 24 h, SOFA score at 72 h, intensive care unit (ICU) length of stay, number of days on mechanical ventilation or renal replacement therapy, vasopressor free days, unnecessary antibiotic administration, and mortality at 28 days. 1148 patients were planned to be analysed; the study period ended after 873 patients were included. RESULTS: 872 patients (mean age 66, 42% female) were analyzed: 387 (44.4%) in the intervention group and 485 (55.6%) in the control group. Median SOFA score was 3 [1-5]. Median time to antibiotic administration was 40 min in the intervention group vs 113 min in the control group (difference - 73 [95% confidence interval (CI) - 93 to - 53]). There was a significantly higher rate, volume, and shorter time to fluid resuscitation within 3 h in the intervention group. There were 47 (12.1%) in-hospital deaths in the intervention group compared to 61 (12.6%) in the control group (difference in percentage - 0.4 [95% CI - 5.1 to 4.2], adjusted relative risk (aRR) 0.81 [95% CI 0.48 to 1.39]). There were no differences between groups for other secondary endpoints. CONCLUSIONS: Among patients with suspected sepsis in the ED, the implementation of the 1-h sepsis bundle was not associated with significant difference in in-hospital mortality. However, this study may be underpowered to report a statistically significant difference between groups.

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.

Impact of Skin Disinfection on Cutaneous Microbiota, before and after Peripheral Venous Catheter Insertion.

Introduction. Patients with invasive medical devices are at high risk for infection. Skin colonization is the initial stage of these infections, leading to the recommendation of practices requiring disinfection using antiseptics. Microbial communities playing a major role in skin health could be impacted by antiseptic procedures. Aim. To characterize and compare the bacterial communities of skin samples from patients before an antisepsis procedure, and after removal of the medical device itself, according to the nature of the antiseptic molecule (povidone iodine or chlorhexidine). Methods. The study focused on alterations in bacterial communities depending on the nature of the antiseptic procedure and type of intravascular device. After amplification of 16S rDNA, libraries (n = 498 samples) were sequenced using MiSeq platform. Results. Using an in-house pipeline (QIIME2 modules), while no alteration in skin microbiota diversity was associated with antiseptic procedure or PVC type, according to culture results (p < 0.05), alterations were at times associated with restricted diversity and higher dissimilarity (p < 0.05). Antiseptic procedures and PVC types were associated with the modification of specific bacterial representations with modulation of the Bacillota/Bacteroidota (Firmicutes/Bacteroidetes) ratio (modulation of C. acnes, Prevotella, Lagierella, and Actinomyces spp.) (p < 0.05). At baseline, the microbiota shows certain bacteria that are significantly associated with future PVC colonization and/or bacteremia (p < 0.05). All of these modulations were associated with altered expression of metabolic pathways (p < 0.05). Discussion. Finally, this work highlights the need to optimize the management of patients requiring intravascular devices, possibly by modulating the skin microbiota.