Securement Device Research Articles

Umbilical Line Securement Bundle to Reduce Line Loss in the Neonate.

Umbilical line migration not only increases the risks of complications but also results in malposition and, ultimately, loss of the umbilical line. To evaluate the use of an umbilical line securement bundle to reduce unintended line discontinuation after line adjustment in the neonate at a single 40-bed Level IV neonatal intensive care unit. A pre-post design of 75 neonates, preimplementation (n=50) and postimplementation (n=25), was analyzed using data collection from the electronic health record. There was a 37.5% absolute reduction in removal of the umbilical line due to malposition after line adjustment utilizing the umbilical line bundle, standardizing the adjustment order, nursing process, and follow-up x-ray evaluation. This absolute reduction has clinical significance although not statistically significant. Provider compliance rates with line adjustment order bundle were 75%, decreasing with additional adjustments (50%). Nursing staff reported comfort with umbilical line management, ranging from 63% to 87% on different tasks. The use of umbilical line bundles reduces rates of line discontinuation due to malposition. The adoption of umbilical line bundles in neonatal intensive care unit practice may help to prevent unintended line discontinuation. There is a need for continued research regarding the use of secondary securement devices for decreased rate of malposition and the timing and methods for surveillance of umbilical line position.

A Randomized, Noninferiority, Comparative Evaluation of Vascular Securement Devices: Cost and Clinical Analysis

Highlights Abstract Background: Peripheral intravenous catheters (PIVCs) are a near universal element of modern medicine with nearly 2 billion PIVCs placed annually worldwide. Virtually all PIVC complications are related to stabilization. Recent innovations in dressings and securement have sought to minimize these complications; however, evidence is lacking in determining superiority of devices and selecting one product over another. In this quality assurance evaluation, we attempted to select a more cost-effective and optimal product for use in our large, tertiary-referral academic institution. Methods: A randomized, noninferiority, comparative evaluation was undertaken to compare an integrated securement device (ISD) new to our institution to our institution’s current standard adhesive securement device (ASD). Patients were selected for randomization based on likelihood of a >5-day postoperative inpatient stay, allowing for prolonged daily follow up and survey of both patients and nurses. Results: Results showed that the ISD outperformed the ASD in terms of efficiency of application, adhesive quality, stability, overall satisfaction, and patient comfort. Additionally, the ISD demonstrated a lower rate of complications than the ASD. Cost analysis revealed that the ISD was 28% less expensive than the ASD, resulting in significant cost savings and fewer venipunctures. Conclusion: Intravenous catheter placement is the most common procedure performed annually in hospitalized patients. Given the large volume of PIVC insertions each year and associated costs, combined with the frequency of complications, it is imperative to identify a more adequate and cost-effective device. Our quality improvement project, at a high-volume, tertiary care referral center, provides the groundwork for similar studies at other institutions and supports a more cost-effective and potentially safe delivery.

Indwelling urinary catheter use and adherence to clinical practice guidelines: A point prevalence study in adult hospital inpatients

Background Approximately 25% of hospitalised adults require an indwelling urinary catheter (IDC) during their hospital stay. IDCs expose patients to risks of infectious and non-infectious complications. Aims To identify IDC prevalence, assess adherence to clinical practice guidelines and patient-reported involvement in IDC care for adult hospital inpatients. Methods This point prevalence study was conducted in 22 wards in a single quaternary hospital. Data was collected by clinical and research nurses working in pairs on a single day. Study outcomes were reported descriptively as frequencies and percentages. Results Of 502 patients included, 77 (15.3%) had an IDC (median duration 99.6 h). The median age of patients with an IDC was 64 years (interquartile range 22–88 years), 54 (70%) were male and one-quarter ( n = 19; 25%) of IDCs were inserted at another hospital. More than half ( n = 44; 57%) of the 77 IDCs had no documented removal plan. Three patients were unavailable for review for observed clinical practices, and it was found 43% ( n = 32/74) lacked a securement device. Of 77 people with IDCs, there were 44 patient responses, and 27 (61.4%) patients did not know the reason for their catheter. Discussion Areas for improvement included securement device use, timely removal plans and patient education for the reason for the device. Regular point prevalence studies to assess use and adherence to clinical practical guidelines can improve safety outcomes for patients requiring IDCs.

Assessment by finite element analysis modelling of tissue strains associated with the use of two different nasogastric tube securement devices.

Nasogastric tube use can lead to pressure injury. Some nasogastric tube securement devices (NG-SD) include hard plastic components. In the current study, we assessed the differences in strain profiles for two NG-SD, one with hard segments and one without hard segments, using finite element analysis (FEA) to measure strain and deformation occurring at the nasogastric tube-tissue interface. FEA in silico models of devices were based on device mechanical test data and clinically relevant placements. Peak strain values were determined by modelling different scenarios using Abaqus software whereby the tubing is moved during wear. The modelling showed peak strains ranging from 52% to 434% for the two NG-SD depending on the tubing placement and device type. Peak strain was always higher for the hard plastic device. Tissue strain energy was a minimum of 133.8 mJ for the NG-SD with no hard parts and a maximum of 311.6 mJ for the NG-SD with hard parts. This study provided evidence through in silico modelling that NG-SD without hard components may impart less strain and stress to tissues which may provide an option for tube securement that is less likely to cause medical device-related pressure injury.

Securement to Prevent Noncuffed Central Venous Catheter Dislodgement in Pediatrics

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. To compare dislodgement of noncuffed CVCs secured with SASS with dislodgement of noncuffed CVCs secured with sutureless securement devices (SSDs). 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. 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. 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. 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). 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. anzctr.org.au Identifier: ACTRN12620000783921.

Effectiveness and safety of a simple catheter securement device aimed at preventing catheter-associated urinary tract infection in intensive care unit patients: A randomized controlled trial.

Clinical practice guidelines for the prevention of catheter associated urinary tract infection (CAUTI) recommend urinary catheter securement in critical patients although there is scant research on its effectiveness. To analyse whether securement of an indwelling urinary catheter (IUC) reduces the risk of CAUTI and meatal pressure injury among intensive care unit (ICU) patients and assess medical adhesive-related skin injury (MARSI) associated with the securement device. Open randomized controlled trial involving patients admitted to two ICUs in Spain. In the intervention group (n = 169 patients), the IUC was secured to the thigh using an in-house device piloted as part of this trial. Controls (n = 181) received standard care, including non-securement of the IUC. Barrier film spray was applied to the securement site with the aim of preventing MARSI. The definitions of the main outcomes were: CAUTI was diagnosed according to the criteria of the European Centre for Disease Prevention and Control, meatal pressure injury was categorized into four grades and MARSI was classified as either erythema or skin tears. Bivariate analysis and multivariate logistic regression were performed. Log-rank and Cox regressions were used to compare risk over time to CAUTI and meatal pressure injury in the two groups. Data from 350 patients were analysed, 169 (48.29%) from IG and 181 (51.71%) from CG. In the multiple logistic regression analysis, IUC securement was an independent protective factor against both CAUTI (RR = 0.2, 95% CI [0.05, 0.67]) and meatal pressure injury (RR = 0.31, 95% CI [0.15, 0.58]). The incidence of MARSI was 7.1%. Effective IUC securement significantly reduces the risk of CAUTI and meatal pressure injury among ICU patients. The in-house device piloted in the present trial is simple for nurses to use, and the incidence of MARSI was low. These results underline the benefits of IUC securement. Indwelling urinary catheter (IUC) securement reduces the risk of urinary tract infection. IUC securement helps prevent meatal pressure injury. IUC securement with in-house devices is safe and effective.

Skin integrity preservation using a nurse-constructed silicone adhesive Foley catheter.

Skin breakdown is common in the intensive care unit (ICU). This pilot evaluation aimed to determine whether a nurse-constructed urinary catheter securement device using a silicone adhesive could reduce the complications of blistering and other skin breakdowns in a high-risk ICU population with Foley catheters. A prospective, non-randomised performance improvement study using a convenience sample was carried out. The study sample consisted of 29 patients with urethral Foley catheters and any degree of thigh oedema in a surgical ICU at an academic quarternary medical center. Patients were fitted with a standard acrylic-adhesive catheter securement device on one thigh and a nurse-constructed device on the contralateral thigh. At the beginning of each 12-hour shift, the nurse moved the Foley catheter from one securement device to the other; the nurse recorded the assessment findings at the end of the shift. The average age of the 29 patients was 61±16 (range 20-87) years. Visible skin compromise occurred in 21% of the time with the standard acrylic securement device; an equal percentage of men and women developed skin breakdown. Oedema status was a significant factor related to skin breakdown. There was no visible damage to the skin associated with the nurse-constructed silicone-adhesive device. A silicone adhesive urinary catheter securement device causes less skin damage than one with acrylic adhesive. One-step application, pain-free and atraumatic removal, and reliable securement are essential considerations in product development.

The impact of small movements with dual lumen cannulae during venovenous extracorporeal membrane oxygenation: A computational fluid dynamics analysis

Background and objectivesVenovenous Extracorporeal Membrane Oxygenation (VV ECMO) provides respiratory support to patients with severe lung disease failing conventional medical therapy. An essential component of the ECMO circuit are the cannulas, which drain and return blood into the body. Despite being anchored to the patient to prevent accidental removal, minor cannula movements are common during ECMO. The clinical and haemodynamic consequences of these small movements are currently unclear. This study investigated the risk of thrombosis and recirculation caused by small movements of a dual lumen cannula (DLC) in an adult using computational fluid dynamics. MethodsThe 3D model of an AVALON Elite DLC (27 Fr) and a patient-specific vena cava and right atrium were generated for an adult patient on ECMO. The baseline cannula position was generated where the return jet enters the tricuspid valve. Alternative cannula positions were obtained by shifting the cannula 5 and 15 mm towards inferior (IVC) and superior (SVC) vena cava, respectively. ECMO settings of 4 L/min blood flow and pulsatile flow at SVC and IVC were applied. Recirculation was defined as a scalar value indicating the infused oxygenated blood inside the drainage lumen, while thrombosis risk was evaluated by shear stress, stagnation volume, washout, and turbulent kinetic energy. ResultsRecirculation for all models was less than 3.1 %. DLC movements between -5 to 15 mm increased shear stress and turbulence kinetic energy up to 24.7 % and 11.8 %, respectively, compared to the baseline cannula position leading to a higher predicted thrombosis risk. All models obtained a complete washout after nine seconds except for when the cannula migrated 15 mm into the SVC, indicating persisting stasis and circulating zones. ConclusionIn conclusion, small DLC movements were not associated with an increased risk of recirculation. However, they may increase the risk of thrombosis due to increased shear rate, turbulence, and slower washout of blood. Developing effective cannula securement devices may reduce this risk.

Reducing umbilical catheter migration rates by using a novel securement device

ObjectiveThis study evaluates the effectiveness of a novel device, LifeBubble, in reducing umbilical cord catheter (UC) migration and associated complications in neonates.Study designA retrospective review was performed at Oregon Health & Science University’s NICU (2019–2021) to compare standard adhesive securement with LifeBubble. The primary outcomes were UC migration, discontinuation due to malposition, and CLABSI incidence. Differences between groups were statistically analyzed and logistic regression used to adjust for potential confounders.ResultsAmong 118 neonates (57 LifeBubble, 61 adhesive), LifeBubble significantly reduced migration of any UC > 1 vertebral body (12.3% vs. 55.7%), including UVC migration (5.3% vs. 39.3%) and UAC migration (7.0% vs 23.0%), as well as UVC discontinuation due to malposition (5.6% vs 37.7%). The number needed to treat (NNT) to prevent one instance of UVC discontinuation is 4.ConclusionLifeBubble effectively reduces UC migration and premature discontinuation, indicating its potential to enhance neonatal care and safety.

Ineffective: Sutures as an Ineffective Securement Device: Editor’s Message

Ineffective: Sutures as an Ineffective Securement Device: Editor’s Message

Novel Umbilical Catheter Securement and Protection Device for Umbilical Line Securement during Laparotomy.

Umbilical catheter malposition rate is high. We compared a Novel Umbilical Securement Device (NUSD) to standard methodologies for neonatal invasive care unit patients undergoing laparotomy. Retrospective study was performed on infants undergoing laparotomy from April 2019 to January 2023. Two neonatologists compared position of umbilical arterial catheter/umbilical venous catheter (UVC) on perioperative chest X-ray (CXRs) in patients with or without NUSD. Eighteen patients underwent laparotomy, of which 8 patients had NUSD (9 lines) and 10 patients did not (14 lines). In NUSD group, mean gestational age was 37 ± 4 weeks and mean birth weight was 2.3 ± 0.9 kg compared with 31 ± 8 weeks and 2.1 ± 1.4 kg in non-NUSD group, respectively. The mean age at surgery was 5 ± 7 and 5 ± 3 days, respectively. No malposition was seen in NUSD group, while 57% of UVCs (28% of lines) were malpositioned postoperatively in non-NUSD group (p = 0.048). NUSD is an umbilical catheter securement device with low malposition rate, specifically during perioperative period with heightened risk for dislodgement. · Umbilical catheters provide reliable access for neonates but have a high rate of malpositioning.. · NUSD is an umbilical catheter securement device with low malposition rate.. · NUSD can be kept in place during laparotomy and can decrease the risk of malpositioning..

Preventing inadvertent drain removal using a novel catheter securement device

Percutaneous drains have provided a minimally invasive way to treat a wide range of disorders from abscess drainage to enteral feeding solutions to treating hydronephrosis. These drains suffer from a high rate of dislodgement of up to 30% resulting in emergency room visits, repeat hospitalizations, and catheter repositioning/replacement procedures, which incur significant morbidity and mortality. Using ex vivo and in vivo models, a force body diagram was utilized to determine the forces experienced by a drainage catheter during dislodgement events, and the individual components which contribute to drainage catheter securement were empirically collected. Prototypes of a skin level catheter securement and valved quick release system were then developed. The system was inspired by capstans used in boating for increasing friction of a line around a central spool and quick release mechanisms used in electronics such as the Apple MagSafe computer charger. The device was tested in a porcine suprapubic model, which demonstrated the effectiveness of the device to prevent drain dislodgement. The prototype demonstrated that the miniaturized versions of technologies used in boating and electronics industries were able to meet the needs of preventing dislodgement of patient drainage catheters.

A retrospective study of subcutaneous anchor securement systems in oncology patients.

Maintaining optimal central venous catheter tip position requires reliable catheter securement. A vital decision about the choice of engineered securement device is often made by what is conveniently available in the insertion kit or default clinical routine. The importance of continuous securement for oncology patients prompted the need for an evaluation of securement options currently available. This study aimed to assess the effectiveness of two engineered securement devices to assist the oncology patient in reaching the end of their catheter need. A retrospective study was conducted to assess patients' ability to finish their therapy with one peripherally inserted central catheter. Implant and explant data for adult oncology patients was evaluated spanning 2007-2021. All patients received a PICC with either an adhesive securement device or a subcutaneous anchor securement system. Partial or complete dislodgement causing the unplanned removal of the PICC occurred at 12% for ASD and 0.4% for SASS (p < 0.0001). The probability of reaching the end of need with one PICC, regardless of the reason for premature removal, at 2 years for patients with an adhesive securement device was 68% (n = 944). For patients with a subcutaneous anchored securement device, it was over 95% (n = 8313). The difference in the probability of reaching the end of the need with one PICC between the two securement devices was calculated at (p < 0.0001). With over 9200 patients and more than a million catheter days, the results of this retrospective study demonstrate the SASS's superiority in assisting the patient to reach the end of need with a single PICC.

SP17. First in Human Testing of a Novel Sutureless Drain Securement Device: A Randomized Clinical Trial

SP17. First in Human Testing of a Novel Sutureless Drain Securement Device: A Randomized Clinical Trial

Early Mobility in Patients With Femoral Catheters

Early Mobility in Patients With Femoral Catheters

Effects of Angled Dynamic Compression Holes in a Tibial Plateau Levelling Osteotomy Plate on Cranially Directed Fragment Displacement.

To compare angled dynamic compression holes in a tibial plateau levelling osteotomy (TPLO) plate to a commercially available TPLO plate in an ovine cadaveric model. Ovine tibias (40 bones) were mounted on a custom-made securement device and radiopaque markers were placed to aid radiographic measurements. A standard TPLO procedure was performed on each tibia with either a custom-made six-hole 3.5 mm angled compression hole plate (APlate) or a six-hole 3.5 mm standard commercial plate (SPlate). Radiographs were obtained before and after tightening of the cortical screws and evaluated by an observer blinded to the plate. Measurements of cranio-caudal displacement (CDisplacement), proximo-distal displacement (PDisplacement) in relation to the long axis of the tibia, and change in tibial plateau angle (TPA) were determined. CDisplacement was significantly greater in APlate (median 0.85 mm, Q1-Q3: 0.575-1.325 mm) compared to SPlate (median 0.00 mm, Q1-Q3: -0.35-0.50 mm, p < 0.0001). There were no significant differences in the PDisplacement (median 0.55 mm, Q1-Q3: 0.075-1.00 mm, p = 0.5066) or TPA change (median -0.50°, Q1-Q3: -1.225-0.25°, p = 0.1846) between the two plate types. APlate increases cranially directed displacement of the osteotomy in a TPLO procedure without causing TPA change. The reduced interfragmentary distance across the whole osteotomy could improve osteotomy healing compared to standard commercial TPLO plates.

Intra-aortic Balloon Pump Securement.

Intra-aortic Balloon Pump Securement.

Securing Endotracheal Tubes During Prone Positioning.

Securing Endotracheal Tubes During Prone Positioning.

A precision-designed gastrostomy button securement device

BackgroundGastrostomy buttons (g-buttons) are commonly placed in children to facilitate weight gain, correct nutritional deficiencies, and provide hydration and/or medication delivery. At our institution, parents are taught to place a gauze sponge under their child's g-button and secure it with strips of tape; however, the g-button still moves in the tract, which delays wound healing and leads to a variety of tract-related complications. We viewed this universal problem as a challenge and a prime opportunity for innovation. MethodsIn 2016, a pediatric surgeon and a team of graduate engineering students outlined the problem, created a list of design requirements, and began to iterate on a variety of device designs. ResultsOver 400 design ideas were iterated upon to various degrees. The first prototype was studied in a small clinical trial, in which 80% of caregivers reported satisfaction with the design, but 90% noted difficulty connecting the extension feeding tube. A second-generation prototype was developed, which included a reusable lid and disposable base layer. Third- generation prototypes added “edge-grippers” to facilitate attaching the extension tubing, plus pre-cut absorbent, sterile gauze pads to fit around the stem of the g-button. Finally, in 2020, the design was finalized with the addition of a childproof hinge between the lid and base layer. ConclusionsAn intuitive g-button securement device was created to simplify daily gauze replacement, reduce tract-related complications, and lower the cost of care. A randomized controlled trial comparing the securement device to the “tic-tac-toe” dressing will begin in early 2022 with results available later this year.

554 Preventing accidental central line removal: Early success through a novel securement device

IntroductionCentral Venous Catheter (CVC) placement and maintenance can be difficult due to non-intact skin and possible surrounding weeping wounds. In addition, routinely used products require intact skin for the adherence of the central line dressing along with sutures or securement devices. With the increased number of line dislodgements, the Burn Intensive Care Unit (BICU) searched for alternative means of line securement. A subcutaneously anchored sutureless system (SASS) was found that could secure the line and allow for improved cleaning around the insertion site. The SASS is a device made of metal which resides in subcutaneous portion of the skin and anchors the CVC while allowing lifting of the catheter to clean underneath.MethodsAfter identification of the SASS product, a trial was implemented. Nurses (RN) and providers were trained virtually by the product representative. Nursing champions were selected to be a liaison between the product representative and the staff. Patients included burn patients or Steven Johnsons (SJS) patients, with large open total body surface area, who had a CVC placed peripherally or centrally between September 2020 to June 2021. A survey was conducted upon insertion of the device, with dressing changes, and upon removal.ResultsIn 2018, there were a total of 14 CVC dislodgements and 12 in the year 2019. For the year 2020, there were 4 dislodgements and 2 in 2021. Both adult and pediatric patients utilized approximately 12 SASS. From the nurses who cared for the patients, 19 responses were obtained regarding the SASS. Overall, 94% of staff recommended this product for use. No accidental removal of the CVC was reported with use of the SASS. With cleaning around the catheter insertion site, 53% believed that they were able to clean better while 47% felt that it was the same with the previous practice. In terms of duration of changing the dressing and maintaining the catheter, 53% felt that it was the same while 47% thought it was faster. During maintenance, the most discomfort reported by patients was 4/10.ConclusionsThe SASS can be implemented as another viable method to prevent accidental dislodgement of the CVC while securing CVC without sutures. In addition, RNs believed it allows for faster cleaning around the insertion site and faster dressing changes with minimal discomfort to the patient. More data can be collected over longer periods of time and to look at its efficacy in non-burn patients.