ABSTRACT
Importance: Catheter dislodgement is a common complication for children with tunneled or peripherally inserted noncuffed central venous catheters (CVCs). A subcutaneous anchor securement system (SASS) may reduce this risk compared with traditional adhesive securement. Objective: To compare dislodgement of noncuffed CVCs secured with SASS with dislodgement of noncuffed CVCs secured with sutureless securement devices (SSDs). Design, Setting, and Participants: The SECURED (Securing Central Venous Catheters to Prevent Dislodegment) trial was a pragmatic, multicenter, superiority randomized clinical trial with an internal pilot and was conducted from August 5, 2020, to August 30, 2022, at 2 Australian quaternary pediatric hospitals. Data analysis was performed in January 2023. Patients aged 0 to 18 years requiring a noncuffed CVC (≥3F catheter) were eligible for inclusion. Follow-up duration was 8 weeks or until device removal. Interventions: Patients were randomly assigned 1:1 to receive an SASS or SSD, stratified by hospital and catheter type. Only 1 catheter was studied per patient. Main Outcomes and Measures: The primary outcome was dislodgement (partial or total), defined as movement of the catheter tip by greater than 1 cm (change in external catheter length) at any point during catheter dwell. Dislodgement, reported as a risk ratio (RR), was estimated using a generalized linear model with binomial family and log link. Secondary outcomes were reported as incidence rate ratios and were analyzed using Poission regression. Outcomes reported as mean differences (MDs) were analyzed using linear regression. Results: Of 310 randomized patients, 175 patients (56.5%) were male and median (IQR) patient age was 48 (16-120) months. A total of 307 patients had a catheter device inserted, of which 153 (49.8%) were SASS and 154 (50.2%) were SSD, and were included in the intention-to-treat (ITT) analysis. Device dislodgement was lower with SASS (8 dislodgements in 153 patients [5.2%]) compared with SSD (35 dislodgements in 154 patients [22.7%]) (RR, 0.23; 95% CI, 0.11-0.48; P < .001). The per-protocol analysis was consistent with the ITT analysis. Partial dislodgement accounted for most dislodgement events, including 6 partial dislodgements in the SASS group (3.9%) and 30 partial dislodgements in the SSD group (19.5%) (RR, 0.18; 95% CI, 0.08-0.42). This contributed to fewer complications during dwell in the SASS group (37 reported complications [24.2%]) vs the SSD group (60 reported complications [39.0%]) (RR, 0.62; 95% CI, 0.44-0.87). Staff reported greater difficulty removing devices anchored with SASS vs SSD (mean [SD], 29.1 [31.3] vs 5.3 [17.0], respectively; MD, 23.8; 95% CI, 16.7-31.0). However, use of SASS resulted in reduced per-participant health care costs of A$36.60 (95% credible interval, 4.25-68.95; US $24.36; 95% credible interval, 2.83-45.89). Conclusions and Relevance: In the SECURED trial, noncuffed CVCs secured with SASS had fewer dislodgements compared with SSDs, with a lower cost per patient and an acceptable safety profile. Future efforts should be directed at SASS implementation at the health service level. Trial Registration: anzctr.org.au Identifier: ACTRN12620000783921.
ABSTRACT
Importance: Peripheral intravenous catheters (PIVCs) frequently fail during treatment causing therapy interruption, pain, recatheterization, and additional health care costs. Midline catheters (MCs) may improve functional dwell time and reduce failure compared with traditional PIVCs. Objective: To compare device failure of MCs with PIVCs. Design, Setting, and Participants: This was a pragmatic, randomized clinical superiority trial with an embedded internal pilot study conducted from July 2020 to May 2022. The study took place in a quaternary pediatric hospital in Brisbane, Queensland, Australia. Inclusion criteria were patients aged 1 to 18 years requiring peripherally compatible intravenous therapy for 4 days or longer. Interventions: Patients were randomly assigned 1:1 to receive a PIVC or MC, stratified by age (≤5 years, >5 years). One catheter was studied per patient. Main Outcomes and Measures: The primary outcome was all-cause device failure, defined as premature cessation of device function. Secondary outcomes included number of insertion attempts, insertion failure, pain (on insertion), procedural time, patient/parent satisfaction (with insertion), device dwell time, device complications during dwell time, additional vascular access devices required to complete treatment, clinician satisfaction (at removal), and health care costs. Results: Of the 128 patients randomly assigned to study groups, 127 patients (median [IQR] age, 7 [2-13] years; 71 male [56%]) had a device inserted, with 65 (51.2%) in the PIVC group and 62 (48.8%) in the MC group. All patients were included in the intention-to-treat analysis. Device failure was lower in patients in the MC group (10 [16.1%]) compared with those in the PIVC group (30 [46.2%]; odds ratio [OR], 0.22; 95% CI, 0.10-0.52; P <.001). MCs were associated with fewer insertion attempts (mean difference [MD], -0.3; 95% CI, -0.5 to 0; P = .04), increased dwell time (MD, 66.9 hours; 95% CI, 36.2-97.5 hours; P <.001), and fewer patients required additional vascular access devices to complete treatment in the MC group (4 [6.5%]) and PIVC group (19 [29.2%]; OR, 0.17; 95% CI, 0.05-0.52; P = .002). Compared with PIVCs, use of MCs was associated with greater patient (9.0 vs 7.1 of 10; P = .002) and parent (9.1 vs 8.2 of 10; P = .02) satisfaction and lower health care costs (AUS -$151.67 [US -$101.13] per person; 95% credible interval, AUS -$171.45 to -$131.90 [US -$114.20 to -$87.95]). Conclusions and Relevance: Findings suggest that MC insertion for patients requiring peripherally compatible intravenous therapy for 4 days or longer should be prioritized to reduce the resource intensive, expensive, and burdensome sequelae of device failure. Trial Registration: Australia New Zealand Clinical Trials Registry, ACTRN12620000724976.
Subject(s)
Catheterization, Peripheral , Adolescent , Child , Child, Preschool , Humans , Male , Australia , Catheterization, Peripheral/adverse effects , Catheters , Equipment Failure , Pain/etiology , Pilot Projects , FemaleABSTRACT
Central venous access devices (CVADs) are vital to enable treatment for children with cancer and other complex health conditions. However, complications effecting the CVAD wound are commonly reported. This study aimed to identify the incidence and prevalence of CVAD-associated skin complications current management, and characteristics associated with complication development, in pediatrics. A prospective observational study performed across medical, oncology, and hematology departments at a tertiary pediatric hospital in Australia, between April and July 2017. Children admitted with CVADs were assessed twice weekly for CVAD-associated skin complications and associated signs and symptoms. The data were analyzed using descriptive statistics (i.e., proportions, frequency) and time-to-event multivariable regression (i.e., hazard ratios [HRs]). Two hundred and seventy-one CVADs were reviewed over 43,787 catheter days, with over one eighth of participants (14%; n = 37) having a CVAD-associated skin complication during their admission (0.95 per 1,000 catheter days, 95% confidence interval [CI; 0.61, 1.17]), most commonly contact dermatitis (11%; n = 29; 0.72 per 1,000 catheter days 95% CI [0.50, 1.04]). Within biweekly checks the median point prevalence of complications varied between 0.4% and 11% and clinical management was wide-ranging. A primary diagnosis of oncology (HR 2.89, 95% CI [1.10, 7.62]) or medical/surgical (HR 2.55, 95% CI [1.04, 6.22]) conditions; plain, nonbordered polyurethane dressings (HR 4.92, 95% CI [2.00, 12.13]); and poor dressing integrity (HR 2.64, 95% CI [1.18, 5.92]) were significantly associated with contact dermatitis. In conclusion, substantial numbers of pediatric patients experience CVAD-associated skin complications, and innovations are necessary to identify, prevent, and treat these health care-associated injuries.
