Securing All intraVenous devices Effectively in hospitalised patients—the SAVE trial: study protocol for a multicentre randomised controlled trial

Introduction: Over 70% of all hospital admissions have a peripheral intravenous device (PIV) inserted; however, the failure rate of PIVs is unacceptably high, with up to 69% of these devices failing before treatment is complete. Failure can be due to dislodgement, phlebitis, occlusion/infiltration and/or infection. This results in interrupted medical therapy; painful phlebitis and reinsertions; increased hospital length of stay, morbidity and mortality from infections; and wasted medical/nursing time. Appropriate PIV dressing and securement may prevent many cases of PIV failure, but little comparative data exist regarding the efficacy of various PIV dressing and securement methods. This trial will investigate the clinical and cost-effectiveness of 4 methods of PIV dressing and securement in preventing PIV failure. Methods and analysis: A multicentre, parallel group, superiority randomised controlled trial with 4 arms, 3 experimental groups (tissue adhesive, bordered polyurethane dressing, sutureless securement device) and 1 control (standard polyurethane dressing) is planned. There will be a 3-year recruitment of 1708 adult patients, with allocation concealment until randomisation by a centralised web-based service. The primary outcome is PIV failure which includes any of: dislodgement, occlusion/infiltration, phlebitis and infection. Secondary outcomes include: types of PIV failure, PIV dwell time, costs, device colonisation, skin colonisation, patient and staff satisfaction. Relative incidence rates of device failure per 100 devices and per 1000 device days with 95% CIs will summarise the impact of each dressing, and test differences between groups. Kaplan-Meier survival curves (with log-rank Mantel-Cox test) will compare device failure over time. p Values of <0.05 will be considered significant. Secondary end points will be compared between groups using parametric or non-parametric techniques appropriate to level of measurement

Stratification of THROMBOTIC RISK in patients that are undergoing to PICC implantation. The “CoRa-MaPiCC STUDY”

Background: The PICC is a central venous system inserted in the peripherally vein. The central peripheral catheter catheter system (PICC=peripherally inserted central catheters) is a widely used procedure in clinical practice by medical and nurse team. PICC has potential complications that are rare but not entirely irrelevant. It is used for continuous and discontinuous treatment and, after a correct insertion procedure, it can be used for a period of time between 1 week to 3 months. The last-generation dispositive has an high-biocompatibility due to the high quality of the materials (silicone or polyurethane), a total length of 40-60 cm and a diameter between 16 to 25 Gauge or 2 to 5 French. Aims: The aim of our study is to evaluate the trombotic risk related to the positioning of the device in relation to the individual risk factors. Therefore we have elaborated the CoRaMaPicc protocol that allows, based on the preliminary data evaluation, to reduce the trombotic risk in patients with high cardiovascular risk profile. Methods: The study has started in July 2016. We have enrolled 30 patients (18 males and 12 females with range age of 30-99 yrs and mean age of 82+13,5 yrs). Enrolled patients have Body mass Index or (BMI) with range from 16,3-26,5 Kg/mq and mean BMI value of 23,5+2,5 Kg/mq. Enrolled patients were subjected to laboratory assessment of cardiovascular risk factors like laboratory assessment of Methyl-Tetra-Hydro-Folate-Reductase or (MTHFR) and Homocysteine, Fibrinogen, D-Dimer, International Normalized Ratio (INR), Prothrombin Time (PT), activated Partial Thromboplastin Time (aPTT), Platelets (PLT), trombotic risk evaluation (CHA2DS2-VASc Score), and bledding risk evaluation (HAS-BLED Score). Before the insertion procedure of the PICC, single or duble lumen (Groshong or Power PICC type), the patient were subjected to a preliminary ultrasound and echo-doppler vein evaluation to underline the presence of atipical anatomical state of the patients veins. After the procedure the patients were subjected to second ultrasound and echo-doppler vein evaluation and then to a radiographic examination to verify the correct position of the PICC. All patients were enrolled for follow- Up to evaluate trombotic complications. Statistical analysis was performed using the Survival Analysis test to evaluate the patients during the follow-up period in relation to thrombotic events. The data obtained from our study have been described taking also into account the data present in the international literature. Setting: The study was performed using a specific setting in a room of the Internal Medicine Department of the Alfredo Fiorini Hospital (Terracina, Italy), guarantee an aseptic procedure , the right comfort for the patients and the appropriate privacy. Discussion: More data in the literature underline the presence of non-eliminable risk factors like anatomic state of the patients vein that can play a variable role of procedural risk factor and can predispose to procedural or post-procedural complication after the implantation procedure. In specific cases it is difficult to asses an echo-doppler examination of heart for meteorism or ascites and radiographic exams for the presence of pleural effusion. The CoRaMaPiCC protocol use different technique to explore the post-insertion period and the follow-up time at 12 week. In case of meteorism or ascites the ultrasound examination of the heart cameras was replaced by the radiographyc evaluation while in case of pleural effusion, the evaluation of the device position was deduced using the only ultrasound approach (when the vein system is explorable). Procedural algorithm utilized in our implant protocol allows to improve the diagnostic capabilities of the conditions that can predispose to thrombotic complications. During the study period (1 year), the PICCs were removed for death (7 patients; 4 patients for irreversible heart disease, 1 patient for cardiogenic shock 1 patient for septic shock and 1 patient for Creutzfeld-Jacob disease), for spontaneously remotion (1 patient for low compliance of the patient) and for end of therapy (22 patients). The presence of cardiovascular risk factors alone is not sufficient for determining statistically significant changes in the thrombotic risk. As reported historically by the description of the wirkow triad, the presence of three clinical signs, and in particular the presence of endothelial damage (functio lesa) is a sine qua non condition for the occurrence of thrombotic episodes. Conclusion: The CoRaMaPicc protocol allows, based on the evaluation of the data, to minimize endothelial damage and therefore to reduce the incidence of the wirchof's triade related with an high trombotic risk. The data were elaborated considering the different thrombotic risk linked to the presence of the homozygous MTHR mutation responsible for the increase of homocysteine values and therefore of the further thrombotic risk. Further studies are needed to expand the number of enrolled patients and increase the follow-up period. Our data give comfortable results but further evaluation are needed to have conclusive results

A Frontline Approach With Peripherally Inserted Versus Centrally Inserted Central Venous Catheters for Remission Induction Chemotherapy Phase of Acute Myeloid Leukemia: A Randomized Comparison

BACKGROUND: The incidence of peripherally inserted central catheter (PICC)-related adverse events has been uncertain in the setting of acute myeloid leukemia (AML) compared with the incidence of centrally inserted central catheter (CICC) adverse events. PATIENTS AND METHODS: We conducted a monocentric, randomized trial of patients with previously untreated AML. Of the 93 patients, 46 had received a PICC and 47 had received a CICC as frontline intravascular device. Thereafter, all patients underwent intensive chemotherapy for hematologic remission induction. The primary endpoint was catheter-related (CR)-bloodstream infection (BSI) and venous thrombosis (VT) rate. The secondary endpoints catheter malfunction, catheter removal, and patient overall survival. RESULTS: The CR-BSI and CR-VT rate in the PICC and CICC groups was 13% and 49%, respectively, with a difference of 36 percentage points (relative risk for CR-BSI or CR-VT, 0.266; P = .0003). The CR-BSI incidence was 1.4 and 7.8 per 1000 catheters daily in the PICC and CICC groups, respectively. Among the CR thromboses, the symptomatic VT rate was 2.1% in the PICC group and 10.6% in the CICC group. In the CICC group, 16 of the 47 patients (34%) had the catheter removed for BSI (n = 5), septic thrombophlebitis (n = 4), VT (n = 2), or malfunction (n = 5) a median of 7 days after insertion. In the PICC group, only 6 of the 46 patients (13%) required catheter removal for VT (n = 2) or malfunction (n = 4). At a median follow-up of 30 days, 6 patients in the CICC group died of CR complications versus none of the patients in the PICC group (P = .012). Using PICCs, the reduction in BSI and symptomatic VT decreased mortality from CR infection and venous thromboembolism. In contrast, the CICC approach led to early catheter removal mostly for difficult-to-treat infectious pathogens. CONCLUSION: Our data have confirmed that BSI and symptomatic VT are the major complications affecting frontline central intravascular device-related morbidity in the leukemia setting. The use of a PICC is safer than that of a CICC and maintains the effectiveness for patients with AML undergoing chemotherapy, with an approximate fourfold lower combined risk of infection or thrombosis at 30 days

Improving central line-associated bloodstream infection prevention bundle compliance to reduce infection rates in a pediatric cardiac intensive care unit.

Background: Central line-associated bloodstream infection (CLABSI) is the most common healthcare-acquired infection in pediatrics. A pediatric acute care facility in Kentucky created a specialized care team in an effort to track CLABSI bundle compliance and reduce central line infections. While rates of infection decreased, a significant number of infections still occurred and staff adherence to facility evidence-based policies and infection prevention interventions remained low. Purpose: To reach the facility’s goal of zero central line-associated bloodstream infections, a quality improvement (QI) project was developed to improve staff knowledge of care and increase staff adherence to policy. Methodology: To create the QI project focused a literature review, and the Institute for Healthcare Improvement (IHI)’s Plan- Do- Study- Act (PDSA) model were used. This project was the first cycle of PDSA, a guide to future cycles. Intervention: Interventions included initiation of biannual CLABSI educational simulation, distribution of a monthly newsletter, and posting bundle elements at the bedside. Results: A 2.25% increase in test score from pre to post-test was obtained and scores on many of the questions increased from pre- to post-test. Audits allowed for the calculation of baseline compliance with the facility’s Central Line- Associated Blood Stream Infection prevention bundle, as well as identified areas where compliance was not adequate. Assessment of the unit’s CLABSI infections post-intervention illustrates that although the quality improvement project’s impact on rate of infection cannot truly be determined, the influence on nursing compliance with the CLABSI bundle resulted in a +32.27% of change

Apical left ventricular cannula sutureless implantation development.

Introduction: Cannulation of the left ventricle (LV) apex is a common surgical procedure for aortic valve bypass and ventricular assist device (VAD) implantation. LV cannulation requires coring of the LV apex and attaching a sewing ring via suture. Although effective, suturing is time-consuming and apical coring can lead to bleeding complications or inflow occlusion. The scope of this project was to design a sutureless-anchoring device for an apical left ventricular (ALV) cannula system. Instrumentation, equipment, and procedures: The sutureless-anchoring device was designed as a conical spring. Five prototypes were fabricated with varying wire diameter (0.045”-0.055”), maximum cone diameter (0.85”-0.975”), and spring height (0.75”-1.25”). The conical springs were attached to PVC cylinders to mimic ALV cannulae. The prototypes were tested through 1) leak test with pressurized porcine hearts, 2) tensile pull test using porcine hearts and an INSTRON, and 3) quantitative assessment of device implantation by cardiothoracic surgeons. Results and Discussion: Leak testing determined that the prototypes created a leak-proof tissue-cannula interface. The prototype with the largest cone and wire diameter combination was able to achieve a tensile failure force similar to that of a clinically-used VAD sewing ring. Other prototypes yielded failure forces below the VAD sewing rings. The quantitative assessment reported that the prototype easily penetrates the tissue and is quicker to implant than sewing rings. Conclusions: This preliminary study demonstrated promise for a sutureless-anchoring device as part of an ALV cannula system. A sutureless implantation method may lead to safer and faster LV cannulation surgeries, thus improving patient outcomes and reducing surgical cost. Recommendations: It is recommended to test springs with larger wire diameter and large end outer diameter combinations than those tested in this study. It is also recommended to create and test multiple prototypes of each variation of spring dimensions

A Bundled Approach to Integrative Care for Peripherally Inserted Extracorporeal Membrane Oxygenation Cannula Insertion Site

Purpose and Rationale: This project is designed to translate the collective knowledge and evidence-based interventions surrounding the reduction of central line-associated bloodstream infections (CLABSIs) and use these evidence-based practices to create an extracorporeal membrane oxygenation (ECMO) cannula site bundle. The desired outcome of creating an ECMO cannula-site bundle is increased cannula site integrity, decreased frequency of dressing changes, and minimized risk of cannula-site infections. Synthesis of Evidence: Currently, there are no clinical practice guidelines for ECMO cannula site care to guide bedside practice. The ELSO Infectious Disease Taskforce recommends implementation of a CLABSI bundle for ECMO site care, but many of the products used for CLABSI prevention are not intended for large ECMO cannula sites. Practice Change and Implementation Strategies: The DNP students will create an ECMO cannula site bundle inspired by the CLABSI evidence available, as there is currently no ECMO specific products available. Evaluation: To evaluate project success, the DNP students will investigate the number of dressing changes required for ECMO insertion sites due to saturated and/or not intact dressings comparing pre and post implementation cohorts. Conclusion and Implications for Practice: This project would serve as a mean to standardize approaches to dressing the ECMO cannula insertion site, and potential serve as a clinical practice guideline to cannula site care

Clinical experience with power-injectable PICCs in intensive care patients

Introduction: In the ICU, peripherally inserted central catheters (PICCs) may be an alternative option to standard central venous catheters, particularly in patients with coagulation disorders or at high risk for infection. Some limits of PICCs (such as low flow rates) may be overcome with the use of power-injectable catheters.Methods: We retrospectively reviewed all of the power-injectable PICCs inserted in adult and pediatric patients in the ICU during a 12-month period, focusing on the rate of complications at insertion and during maintenance.Results: We collected 89 power-injectable PICCs (in adults and in children), both multiple and single lumen. All insertions were successful. There were no major complications at insertion and no episodes of catheter-related bloodstream infection. Non-infective complications during management were not clinically significant. There was one episode of symptomatic thrombosis during the stay in the ICU and one episode after transfer of a patient to a non-intensive ward.Conclusion: Power-injectable PICCs have many advantages in the ICU: they can be used as multipurpose central lines for any type of infusion including high-flow infusion, for hemodynamic monitoring, and for high-pressure injection of contrast media during radiological procedures. Their insertion is successful in 100% of cases and is not associated with significant risks, even in patients with coagulation disorders. Their maintenance is associated with an extremely low rate of infective and non-infective complications. © 2012 Pittiruti et al.; licensee BioMed Central Ltd

Critical Care and Resuscitation

Another option for ACs is to use a sutureless securement device (SSD), strong adhesive pads that offer additional anchor points into which the AC can be clipped for securement, with an SPU dressing still used as a wound covering. After implementation of SSDs in a United States ICU, AC failure rates were 60/468 (13%). A historical control group using adhesive strips saw AC failure of 253/ 995 (25%) (P &lt; 0.001). 3 The Centers for Disease Control and Prevention recommend SSDs for central venous catheters to prevent vessel inflammation, catheter migration o

Revisão Sistemática das Diferentes Técnicas de Fixação de Cateter Venoso Central

TCC (graduação) - Universidade Federal de Santa Catarina, Centro de Ciências da Saúde, Medicina.Introdução: Apesar de diferentes técnicas de fixação do cateter venoso central serem utiliza das na prática clínica, não está claro qual é o melhor para diminuir a incidência de infecção de corrente sanguínea (IPCS) e outras complicações relacionadas a esse dispositivo. Objetivo: Avaliar qual o melhor método de fixação de cateteres venosos centrais para reduzir a incidência de infecção de corrente sanguínea em pacientes adultos hospitalizados. Métodos: Uma revisão sistemática foi realizada por meio de busca no PubMed, Embase, Sco pus, Web of Science, Lilacs, Cochrane Library, Open Gray, Google Scholar and Clinicaltri als.gov, para encontrar ensaios clínicos randomizados comparando diferentes métodos de fi xação do cateter venoso em pacientes adultos hospitalizados. O protocolo da revisão foi previ amente registrada no PROSPERO (International Prospective Register of Systematic Reviews) sob registro CRD42022380233. Devido ao baixo número de estudos encontrados e a hetero neidade entre esses, os resultados foram sumarizados por meio de uma análise qualitativa. Resultados: Quatro estudos foram incluídos na revisão, totalizando 701 pacientes. Os estudos divergiam quanto aos métodos de fixação utilizados nos diferentes grupos de intervenção e quanto aos desfechos avaliados. De forma geral, métodos sem a utilização de sutura parecem se associar a uma menor taxa de infecção de corrente sanguínea. Esses métodos incluíram di ferentes dispositivos e equipamentos como cola cirurtica, adesivos e curativos. Por outro lado, métodos que utilizam sutura para fixar o cateter parecem se associar a menor incidência de desalojamento do cateter. Esses métodos incluíram técnicas como a bailarina (ponto na pela e e fio envolto e suturado na parte proximal do cateter) e também a borboleta (utilização de um dispositivo fornecido pelos fabricantes para fixação com sutura na pele). Conclusão: Apesar de técnicas livres de sutura se associarem a menor taxa de infecção de corrente sanguínea e técnicas com sutura com menor taxa de desalojamento do cateter, esta revisão não deixa claro qual o melhor método de fixação para prevenir esses desfechos, uma vez que os estudos incluídos foram limitados metodologicamente e heterogêneos entre si. En saios ranomizados com poder amostral adequado e metodologicamente bem desenhados são necessários para responder a pergunta desta revisão