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SecurAcath for Securing Peripherally Inserted Central Catheters: A NICE Medical Technology Guidance.

ABSTRACT: Central venous catheters are commonly used to deliver therapies and to monitor patients, and require securing at the point of percutaneous entry to avoid dislodgement. SecurAcath is a catheter securement device designed for central venous catheters. The National Institute for Health and Care Excellence, as a part of its Medical Technologies Evaluation Programme, selected this device for evaluation and invited the manufacturer, Interrad Medical, to submit clinical and economic evidence. The King's Technology Evaluation Centre, an External Assessment Centre commissioned by the National Institute for Health and Care Excellence, independently critiqued the manufacturer's submissions. The External Assessment Centre found a lack of evidence comparing SecurAcath with alternative approaches to securement (StatLock, suturing, tape securement), with one unpublished randomised controlled trial providing the strongest evidence. The External Assessment Centre conducted a new systematic review and meta-analysis and concluded that there is some evidence indicating the non-inferiority of SecurAcath compared to StatLock. The External Assessment Centre considered the manufacturer's economic model to be appropriate but made revisions to some parameters and noted significant heterogeneity in the included studies. The revised model indicated that StatLock was more cost effective than SecurAcath for catheter indwell times of up to 5 days; however, for medium- and long-term indwell times, SecurAcath was the most cost-effective option. The National Institute for Health and Care Excellence Medical Technologies Guidance MTG 34, issued in June 2017, recommended the adoption of SecurAcath for securing peripherally inserted central catheters within the National Health Service in England.

SUBMITTER: Macmillan T

PROVIDER: S-EPMC6244619 | biostudies-literature | 2018 Dec

REPOSITORIES: biostudies-literature

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SecurAcath for Securing Peripherally Inserted Central Catheters: A NICE Medical Technology Guidance.

Macmillan Tom T Pennington Mark M Summers Jennifer A JA Goddard Kate K Zala Darshan D Herz Naomi N Peacock Janet L JL Keevil Stephen S Chalkidou Anastasia A

Applied health economics and health policy 20181201 6

Central venous catheters are commonly used to deliver therapies and to monitor patients, and require securing at the point of percutaneous entry to avoid dislodgement. SecurAcath is a catheter securement device designed for central venous catheters. The National Institute for Health and Care Excellence, as a part of its Medical Technologies Evaluation Programme, selected this device for evaluation and invited the manufacturer, Interrad Medical, to submit clinical and economic evidence. The King' ...[more]

PMID: 30123950

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Project description:Use of peripherally inserted central catheters has expanded rapidly, but the consequences for patients who eventually require hemodialysis are undefined.Our national, population-based analysis included 33,918 adult Medicare beneficiaries from the US Renal Data System who initiated hemodialysis with central venous catheters as their sole vascular access in 2010 and 2011. We used linked Medicare claims to identify peripherally inserted central catheter exposures and evaluate the associations of peripherally inserted central catheter placement with transition to working arteriovenous fistulas or grafts and patient survival using a Cox model with time-dependent variables.Among 33,918 individuals initiating hemodialysis with a catheter as sole access, 12.6% had received at least one peripherally inserted central catheter. Median follow-up was 404 days (interquartile range, 103-680 days). Among 6487 peripherally inserted central catheters placed, 3435 (53%) were placed within the 2 years before hemodialysis initiation, and 3052 (47%) were placed afterward. Multiple peripherally inserted central catheters were placed in 30% of patients exposed to peripherally inserted central catheters. Recipients of peripherally inserted central catheters were more likely to be women and have comorbid diagnoses and less likely to have received predialysis nephrology care. After adjustment for clinical and demographic factors, peripherally inserted central catheters placed before or after hemodialysis initiation were independently associated with lower likelihoods of transition to any working fistula or graft (hazard ratio for prehemodialysis peripherally inserted central catheter, 0.85; 95% confidence interval, 0.79 to 0.91; hazard ratio for posthemodialysis peripherally inserted central catheter, 0.81; 95% confidence interval, 0.73 to 0.89).Peripherally inserted central catheter placement was common and associated with adverse vascular access outcomes. Recognition of potential long-term adverse consequences of peripherally inserted central catheters is essential for clinicians caring for patients with CKD.

Project description:IntroductionUltrasound-guided venipuncture and tip location by intracavitary electrocardiogram have many advantages during the insertion of peripherally inserted central catheters, both in terms of safety and cost-effectiveness. Recently, a new tip-conductive peripherally inserted central catheters and new Doppler ultrasound device integrated with intracavitary electrocardiogram have been introduced into clinical practice in China. A randomized multicenter study (clinical trial no. NCT03230357) was performed to verify the feasibility and accuracy of intracavitary electrocardiogram, as performed with this new peripherally inserted central catheters and device.MethodsOur study enrolled a total of 2250 adult patients in 10 different Chinese hospitals. The patients were randomly assigned to either the study group (intracavitary electrocardiogram) or the control group (anatomical landmark guidance) in a 2:1 allocation. Ultrasound was used in both groups for venipuncture and tip navigation. All patients underwent chest X-ray after the procedure to verify the position of the catheter tip.ResultsNo insertion-related complications were reported in either group. In the study group, first-attempt successful tip location was 91.7% (95% confidence interval: 90.3%-93.1%), significantly higher than 78.9% (95% confidence interval: 76.0%-81.9%) observed in the control group (p < 0.001). As evaluated by post-procedural chest X-ray, tip location in the study group had a sensitivity of 99.3% (95% confidence interval: 98.8%-99.7%), significantly higher than 86.8% (95% confidence interval: 84.4%-89.2%) observed in the anatomical landmark group (p < 0.001).ConclusionThese results indicated that during peripherally inserted central catheters insertion in adult patients, tip location with intracavitary electrocardiogram guidance, as carried out by a new tip-conductive peripherally inserted central catheters and intracavitary electrocardiogram integrated ultrasound device, was more effective and more accurate than tip location using anatomical landmarks.

Project description:BackgroundPeripherally inserted central catheters (PICCs) are used commonly to administer antibiotics to people with cystic fibrosis (CF), but their use can be complicated by venous thrombosis and catheter occlusion.Research questionWhich participant-, catheter-, and catheter management-level attributes are associated with increased risk of complications of PICCs among people with CF?Study design and methodsThis was a prospective observational study of adults and children with CF who received PICCs at 10 CF care centers in the United States. The primary end point was defined as occlusion of the catheter resulting in unplanned removal, symptomatic venous thrombosis in the extremity containing the catheter, or both. Three categories of composite secondary outcomes were identified: difficult line placement, local soft tissue or skin reactions, and catheter malfunction. Data specific to the participant, catheter placement, and catheter management were collected in a centralized database. Risk factors for primary and secondary outcomes were analyzed by multivariate logistic regression.ResultsBetween June 2018 and July 2021, 157 adults and 103 children older than 6 years with CF had 375 PICCs placed. Patients underwent 4,828 catheter-days of observation. Of the 375 PICCs, 334 (89%) were ≤ 4.5 F, 342 (91%) were single lumen, and 366 (98%) were placed using ultrasound guidance. The primary outcome occurred in 15 PICCs for an event rate of 3.11 per 1,000 catheter-days. No cases of catheter-related bloodstream infection occurred. Other secondary outcomes developed in 147 of 375 catheters (39%). Despite evidence of practice variation, no risk factors for the primary outcome and few risk factors for secondary outcomes were identified.InterpretationThis study affirmed the safety of contemporary approaches to inserting and using PICCs in people with CF. Given the low rate of complications in this study, observations may reflect a widespread shift to selecting smaller-diameter PICCs and using ultrasound to guide their placement.

Project description:OBJECTIVES:To assess the effect on needed nursing time for dressing change. DESIGN, SETTING, PARTICIPANTS:A parallel-group, open-label, randomised controlled trial in patients who are in need for a peripherally inserted central catheter insertion in one teaching hospital in Belgium. The follow-up lasted 180 days or until catheter removal, whatever came first. A computer generated table was used to allocate devices. Randomised patients were 105 adults (StatLock, n=53; SecurAcath, n=52) and primary analysis was based on all patients (n=92) with time measurements (StatLock, n=43; SecurAcath, n=49). INTERVENTIONS:StatLock which has to be changed weekly versus SecurAcath which could remain in place for the complete catheter dwell time. MAIN OUTCOME MEASURE:Needed time for the dressing change at each dressing change (SecurAcath) or at each dressing change combined with the change of the securement device (StatLock). RESULTS:Median time needed for dressing change was 7.3?min (95%?CI 6.4?min to 8.3?min) in the StatLock group and in the SecurAcath group 4.3?min (95%?CI 3.8 min to 4.9?min) (P<0.0001). The time in the SecurAcath group was reduced with 41% (95% CI 29% to 51%). Incidence rates of migration, dislodgement and catheter-related bloodstream infection were comparable across groups. Pain scores were higher with SecurAcath than with StatLock at insertion (P=0.02) and at removal (P<0.001) and comparable during dressing change (P=0.38) and during dwell time (P=0.995). User-friendliness was scored at insertion and removal. All statements regarding the user-friendliness were scored significantly higher for StatLock than for SecurAcath (P<0.05). Only for the statement regarding the recommending routine use of the device, which was asked at removal, no difference was found between the two devices (P=0.32). CONCLUSION:Use of SecurAcath saves time during dressing change compared with StatLock. Training on correct placement and removal of SecurAcath is critical to minimise pain. TRIAL REGISTRATION NUMBER:NCT02311127; Pre-results.

Project description:ObjectivesThe use of peripherally inserted central catheters (PICCs) are an integral part of caring for hospitalised children. We sought to estimate the incidence of and identify the risk factors for complications associated with PICCs in an advanced registered nurse practitioners (ARNP)-driven programme.DesignRetrospective cohort study.SettingSingle-centre, large quaternary children's hospital.ParticipantsHospitalised children who had PICC inserted from 1 January 2010 to 31 December 2016.InterventionsNone.Measurement and main resultsA total of 2558 PICCs were placed during the study period. Mean age at PICC insertion was 8.7 years, mean dwell time was 17.7 days. The majority of PICCs (97.8%) were placed by ARNP. Most were placed in a single attempt (79.6%). Mean PICC residual external length outside was 2.1±2.7 cm. The rate of central line-associated bloodstream infection (CLABSI), thrombosis and significant bleeding were 1.9%, 1% and 0.2%, respectively. The CLABSI rate in infants and early childhood was higher than those aged ≥5 years (2.8%, 3.1%, respectively vs 1.3%). In a multivariate analysis after adjustment of confounding effects of race and gender, infants (OR= 2.24, CI=1.14 to 4.39, p=0.02) and early childhood cohort (OR=2.37, CI=1.12 to 5.01, p=0.02) were associated with significantly higher odds of developing CLABSI compared with ≥5 years old. In the early childhood cohort, PICCs with longer residual external catheter length (OR=1.30, 95% CI=1.07 to 1.57, p=0.008) and those placed in the operating room (OR=5.49, 95% CI=1.03 to 29.19, p=0.04), were associated with significantly greater risk of developing CLABSI.ConclusionsThe majority of PICCs were successfully placed by ARNPs on the first attempt and had a low incidence of complications. Infants required more attempts for successful PICC placement than older children. The presence of residual external catheter length and placement in the operating room were independent predictors of CLABSI in younger children.

Dataset Information

SecurAcath for Securing Peripherally Inserted Central Catheters: A NICE Medical Technology Guidance.

Publications

SecurAcath for Securing Peripherally Inserted Central Catheters: A NICE Medical Technology Guidance.

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