Effect of a thin-tipped short bevel needle for peripheral intravenous access on the compressive deformation and displacement of the vein: A preclinical study.

BACKGROUND: Peripheral intravenous catheter (PIVC) insertion often fails on the first attempt. Risk factors include small vein size and dehydration, causing vein deformation and displacement due to puncture resistance of the vessel. The authors developed a short, thin-tipped bevel needle and compared its puncture performance with needles of four available PIVCs using an ex vivo model. METHODS: The PIVC with the thin-tipped short bevel needle was compared to four available PIVCs using an ex vivo model which simulated the cephalic vein of the human forearm. The ex vivo model consisted of a porcine shoulder and porcine internal jugular vein, and was used for evaluation of the rate of vein deformation and vessel displacement during needle insertion. RESULTS: An ex vivo model was created with a vessel diameter of 2.7-3.7 mm and a depth of 2-5 mm. The thin-tipped short bevel PIVC needle was associated with a significantly lower compressive deformation rate and venous displacement compared to the needles of the other four PIVCs. CONCLUSION: The thin-tipped short bevel needle induced lower compressive deformation and displacement of the vein than the conventional needles. This needle has the potential to improve the first-attempt success rate of peripheral intravenous catheterization in patients with difficult venous access.

Evaluation of a thermosensitive liquid crystal film for catheterization site assessment immediately following chemotherapy administration: An observational study.

PURPOSE: Extravasation incidence is exceptionally low; however, ulceration or necrosis occurs in severe cases, possibly requiring surgical treatment. Early extravasation signs and symptoms are not always evident on treatment day, and inflammation, which leads to ulceration or necrosis, may appear several days later. Therefore, to minimize damage, identification of high-risk groups is required. This study aims to investigate the relationship between subcutaneous edema which is an early extravasation sign, and skin surface temperature using a thermosensitive liquid crystal film. METHODS: Patients receiving chemotherapy through a peripheral intravenous catheter were recruited. Subcutaneous tissue around the catheterization site was observed for the presence of subcutaneous edema by ultrasonography. During chemotherapy initiation, a thermosensitive liquid crystal film was placed on the catheterization site. Color changes of the film were observed, and each case was classified according to low-temperature distribution patterns. To investigate the factors associated with temperature distribution pattern, logistic regression analysis was performed using clinically selected independent variables. RESULTS: Data from 63 patients were analyzed. No obvious extravasation was observed. Film analysis revealed 34 cases of broadening low-temperature area from the vein and 23 cases of non-broadening low-temperature area from the vein. Subcutaneous edema was observed in 18 patients: 17 with broadening low-temperature area from the vein and 1 with non-broadening low-temperature area from the vein. Subcutaneous edema was positively correlated with broadening low-temperature area from the vein. CONCLUSION: Catheter site skin temperature distribution pattern during chemotherapy was associated with subcutaneous edema which is the early extravasation sign immediately after chemotherapy.

A short bevel needle with a very thin tip improves vein puncture performance of peripheral intravenous catheters: An experimental study.

BACKGROUND: Peripheral intravenous catheter placement is frequently unsuccessful at the first attempt. One suggested risk factor is a small vein size, because of the consequences of mechanical forces generated by the needle tip. We developed short bevel needles with a very thin tip and evaluated their puncture performance in two in vitro models. METHODS: Peripheral intravenous catheters with a new needle ground using the lancet method (experimental catheter (L)) or backcut method (experimental catheter (B)) were compared with a conventional peripheral intravenous catheter (Surshield Surflo®) in a penetration force test and a tube puncture test. Penetration forces were measured when peripheral intravenous catheters penetrated a polyethylene sheet. The tube puncture test was used to evaluate whether the peripheral intravenous catheters could puncture a polyvinyl chloride tube at two positions, at the center and at 0.5 mm from the center of the tube. RESULTS: Mean penetration forces at the needle tip produced by experimental catheters (L) (0.05 N) and (B) (0.04 N) were significantly lower than those produced by the conventional catheter (0.09 N) (p < 0.01). At the catheter tip, mean forces produced by experimental catheter (B) and the conventional catheter were 0.16 N and 0.26 N, respectively (p < 0.05). In the tube puncture test, the frequency at which the conventional catheter punctured the center-shifted site on the tube at an angle of 20° and speed of 50 mm/min was low (40%). In contrast, experimental catheters (L) and (B) were 100% successful at puncturing both the center and center-shifted sites at 20°. CONCLUSION: Puncture performance was comparable between the lancet-ground and backcut-ground needles except for penetration forces at the catheter tip. The experimental catheters produced lower penetration forces and induced puncture without target displacement at smaller angles compared with the conventional catheter. Therefore, optimization of the needle can prevent vein deformation and movement, which may increase the first-attempt success rate.

Vascular endothelium damage from catheter-induced mechanical stimulation causes catheter sleeve formation in a rabbit model.

BACKGROUND: Intravenous catheters are widely used but are often removed due to complications associated with catheter sleeve formation. A catheter sleeve can develop from a thrombus, and catheter-induced vascular endothelium damage may be a critical factor for thrombus formation. We investigated the effect of catheter-induced mechanical stimulation on venous endothelial cells and catheter sleeve formation and the efficacy of anti-thrombogenic technology for preventing catheter sleeve formation in vivo. METHODS: We surgically implanted poly(2-methoxyethyl acrylate)-coated and uncoated catheters with and without a stylet into the right external jugular vein of a rabbit model for 14 days. Catheter sleeve formation and the ratio of residual venous endothelial cells were compared using histological examination and immunostaining with an anti-CD31 antibody, respectively. RESULTS: Stiffening an uncoated catheter with a stylet induced catheter sleeve formation along more than two-thirds of the length of the catheter. The ratios of residual venous endothelial cells at the tip of uncoated catheters with and without a stylet were 3% and 36%, respectively. While poly(2-methoxyethyl acrylate) coating also reduced the ratio of venous endothelial cells at the tip of the stiffened catheter (12%), it prevented external thrombus and catheter sleeve formation. CONCLUSION: High levels of mechanical stimulation can affect catheter-related thrombosis and promote catheter sleeve formation, and anti-thrombogenic technology such as a poly(2-methoxyethyl acrylate) coating reduces thrombus formation and can prevent catheter sleeve formation on stiffened catheters. Further studies are required to determine the maximum degree of venous endothelial cell damage before catheter sleeve formation and to compare other anti-thrombogenic technologies with poly(2-methoxyethyl acrylate) for preventing catheter sleeve formation.

Prosthesis Used in Microvascular Decompressions: A Multicenter Survey in Japan Focusing on Adverse Events.

OBJECTIVE: To investigate the characteristics of materials used as prostheses for microvascular decompression surgery (MVDs) in Japan and their possible adverse events (AEs) to determine preferable materials for MVDs. METHODS: A questionnaire was sent to all members of the Japanese Society for MVDs, and answers were obtained from 59 institutions. RESULTS: Among a total of 2789 MVDs, 1088 operations for trigeminal neuralgia, 1670 for hemifacial spasm, and 31 others, including 117 reoperations, were performed between April 2011 and March 2014. Nonabsorbable material was used in 96.5% of MVDs, including polytetrafluoroethylene (PTFE) (80.5%), polyurethane (11.9%), expanded PTFE (2.1%), and silk thread (1.47%). The use of absorbable materials, including fibrin glue (87.5%), cellulose (13.5%), gelatin (4,77%), and collagen (1.76%), was reported. The major combinations were PTFE with fibrin glue (58.7%) followed by PTFE alone (7.60%). Eighty-eight AEs in 85 (3.2%) cases were reported among 2672 first operations. AEs included 51 central nervous system dysfunctions, 15 wound infections/dehiscence, and 10 others, which were presumed to be related to the intraoperative procedure. Among relatively high-, moderate-, and low-volume centers, there were no significant differences in the frequency of AEs (P = 0.077). Tissue-prosthesis adhesion and/or granuloma formation were reported in 13 cases of 117 reoperations. The incidence of adhesion-related recurrence was 11.1% of all reoperations. CONCLUSIONS: The number of AEs was quite low in this survey, and intradural use of any prosthesis reported in this paper might be justified; however, further development of easily handled and less-adhesive prosthesis materials is awaited.

Ultrasonographic assessment of an induration caused by extravasation of a nonvesicant anticancer drug: A case report.

RATIONALE: Induration may occur after an anticancer drug extravasation in patients who recurrently receive chemotherapy because of reduced choice of an appropriate vein for inserting a peripheral intravenous catheter, resulting in catheter placement difficulty. Although induration affects treatment, its size, shape, or hardness remains unclear in the conventional observation method using palpation and inspection. Here, we report our observation results in using ultrasonography to assess the induration that occurred after an anticancer drug extravasation as a new assessment method. PATIENT CONCERNS: A 58-year-old woman with cervical cancer who complained of pain during the administration of a nonvesicant anticancer drug via a peripheral intravenous catheter. The medical staff's examination showed a swollen site; therefore, the catheter was replaced. DIAGNOSIS: Induration occurred on the site after an extravasation. Over 6 months later, pigmentation and induration, which can easily be confirmed through palpation, persisted. INTERVENTIONS: The subcutaneous tissue in the induration site was observed using ultrasonography (B-mode and elastography). OUTCOMES: The subcutaneous tissue might have degenerated the tissues surrounding the vein, making it thinner. Moreover, the hardness of the subcutaneous tissue was approximately 7 times than that of the surrounding tissues. LESSONS: Induration that affects the vein form and its surrounding tissues should be prevented, and ultrasonography is an effective method to objectively observe the site where extravasation occurred.

Impact of Squeezing Condition to Obtain Sufficient Blood Volume for Self-Monitoring of Blood Glucose Using an Automatic Puncturing and Sampling System.

Blood sampling for self-monitoring of blood glucose is difficult for the elderly with low dexterity. We developed and tested the utility of an automatic puncturing and sampling (APS) system as a part of an automatic SMBG device, but success rates of securing sufficient blood volume was low (61.9%). Thus, the squeezing condition was changed to increase its success rate. The aim of this study is to investigate the impact to the amount of bleeding by making changes to the squeezing condition. In our previous experiment, blood sampling was performed simultaneously with squeezing, whereas the present study tested blood sampling after squeezing. This method increased the success rate (75%) among eight subjects who had a low success rate (25%) in the previous experiment using the APS system.

Exploring the causes of peripheral intravenous catheter failure based on shape of catheters removed from various insertion sites.

The risk of peripheral intravenous catheter failure varies according to the insertion site. This study examined catheter shape just after removal to evaluate the causes of catheter failure according to site. This study was a secondary analysis of previous study data. Our observational study was conducted during a 6-month period at The University of Tokyo Hospital. Participants were hospitalized adults who received infusion therapy via a short peripheral catheter. We acquired ultrasound images of blood vessels and surrounding tissues at the catheter insertion site before catheter removal and clinical images of the removed catheters. We analyzed 184 catheters from 142 participants. There were no significant differences in the catheter failure rate (29.9%) among insertion sites. Curvature in the middle of the catheter was present in 9.2% of cases; the median bend angle at the catheter base was 9.1° (range: 0.0°-68.3°). The bend angle of catheters inserted in the upper arm was significantly greater than of catheters in the forearm (p = 0.013). Catheter curvature was related to catheter failure (14.8% of failed catheters had curvature; p = 0.035) and occlusion (35.3% of occluded catheters had curvature; p = 0.008) in upper arm and forearm placements. The median distance from the elbow to the insertion site was shorter for failed catheters than for surviving catheters. To prevent catheter failure, especially occlusion resulting from catheter curvature, a catheter should be inserted at an appropriate insertion site far from the antecubital fossa.

Evaluation of the Predictive Validity of Thermography in Identifying Extravasation With Intravenous Chemotherapy Infusions.

Early detection of extravasation is important, but conventional methods of detection lack objectivity and reliability. This study evaluated the predictive validity of thermography for identifying extravasation during intravenous antineoplastic therapy. Of 257 patients who received chemotherapy through peripheral veins, extravasation was identified in 26. Thermography was performed every 15 to 30 minutes during the infusions. Sensitivity, specificity, positive predictive value, and negative predictive value using thermography were 84.6%, 94.8%, 64.7%, and 98.2%, respectively. This study showed that thermography offers an accurate prediction of extravasation.

Development of an Automatic Puncturing and Sampling System for a Self-Monitoring Blood Glucose Device.

BACKGROUND: Performing self-monitoring of blood glucose (SMBG) is a clinical challenge for elderly people with low dexterity. An all-in-one-type SMBG device that can simply and easily puncture and monitor would be useful for them. We developed an automatic skin-puncturing and blood-sampling (APS) system for introducing of an all-in-one-type SMBG device. The aims of this study were to determine if the developed APS system, which has automatic puncturing, squeezing, and application functions, could provide sufficient blood sample volumes for SMBG and to determine the factors associated with failure in the use of the system by adult volunteers. METHODS: We investigated the success rate of obtaining a 0.8-µL sample volume using the APS system and determined the factors associated with failure in 140 adult volunteers. The participant characteristics, induration of puncturing sites, and states of finger grip conditions were evaluated as factors of a puncturing failure. The participant characteristics, skin hydration, states of finger grip, skin elasticity of the finger pad, and blood flow were evaluated as factors of a squeezing failure. RESULTS: The success rate was 61.9%. Puncturing failure was 21.6%, and squeezing failure was 16.5%. Automatic puncturing factors associated with failure were male sex, larger finger diameter, and thicker finger pad. The only squeezing failure factor was lower peripheral skin temperature. CONCLUSIONS: Improvement of the finger station groove shape to prevent ischemia and the squeezing angle would be useful developments of the all-in-one-type SMBG device for elderly people with decreased dexterity.

Is Thrombus With Subcutaneous Edema Detected by Ultrasonography Related to Short Peripheral Catheter Failure? A Prospective Observational Study.

Short peripheral catheter (SPC) failure is an important clinical problem. The purpose of this study was to clarify the relationship between SPC failure and etiologies such as thrombus, subcutaneous edema, and catheter dislodgment using ultrasonography and to explore the risk factors associated with the etiologies. Two hundred catheters that were in use for infusion, excluding chemotherapy, were observed. Risk factors were examined by logistic regression analysis. Sixty catheters were removed as the result of SPC failure. Frequency of thrombus with subcutaneous edema in SPC failure cases was significantly greater than in those cases where therapy was completed without complications (P < .01). Multivariate analysis demonstrated that 2 or more insertion attempts were significantly associated with thrombus with subcutaneous edema. Results suggest that subsurface skin assessment for catheterization could prevent SPC failure.

Continuous thermographic observation may predict extravasation in chemotherapy-treated patients.

PURPOSE: Extravasation, or leakage of vesicant drugs into subcutaneous tissues, causes serious complications such as induration and necrosis in chemotherapy-treated patients. As macroscopic observation may overlook symptoms during infusion, we focused on skin temperature changes at puncture sites and studied thermographic patterns related to induration or necrosis caused by extravasation. METHODS: Outpatients undergoing chemotherapy using peripheral intravenous catheters were enrolled in this prospective observational study. We filmed and classified infrared thermography movies of puncture sites during infusion; ultrasonography was also utilized at puncture sites to observe the subcutaneous condition. Multiple logistic regression analysis was performed to examine the association of thermographic patterns with induration or necrosis observed on the next chemotherapy day. Differences in patient characteristics, puncture sites, and infusions were analyzed by Mann-Whitney's U test and Fisher's exact test according to thermographic patterns. RESULTS: Eight patients developed induration among 74 observations in 62 patients. Among six thermographic patterns, a fan-shaped lower temperature area gradually spreading from the puncture site (fan at puncture site) was significantly associated with induration. Ultrasonography revealed that catheters of patients with fan at puncture site remained in the vein at the end of infusion, indicating that the infusion probably leaked from the puncture site. Patients with fan at puncture site had no significant differences in characteristics and infusion conditions compared with those with the other five thermographic patterns. CONCLUSION: We determined that fan at puncture site was related to induration caused by extravasation. Continuous thermographic observation may enable us to predict adverse events of chemotherapy.

Low-angled peripheral intravenous catheter tip placement decreases phlebitis.

INTRODUCTION: Peripheral intravenous catheters (PIVCs) are frequently removed due to phlebitis. We hypothesized that catheters made of polyurethane, which is more flexible than Teflon, would decrease phlebitis, and that flexibility could be estimated by measuring the catheter-tip angle. Ultrasonography in two groups of patients with different catheter types was then used to compare catheter-tip angles and phlebitis. METHODS: Observational studies were carried out at a medical ward in a university hospital. Infusion therapy was administered to one group of patients in 2014 using Teflon catheters (control group, n = 200), and to another group of patients in 2015 using polyurethane catheters (investigational group, n = 207). The symptoms were assessed according to a scale developed by the Infusion Nurses Society. Long-axis ultrasonography images taken immediately before catheter removal were used to measure the angle between the central line of the catheter within 2 mm from the distal point and a tangent to the vessel wall. RESULTS: There were no significant differences between the two groups with respect to sex, age, and medical diagnosis. In the control and investigational groups, the rates of phlebitis were 37% (73/200) and 17% (36/207), respectively (p<0.001). The median angles of the catheter tip were 7.8° and 4.1°, respectively (p<0.001). Phlebitis occurred more frequently when the catheter-tip was placed at angle >5.8°. DISCUSSION: The frequency of phlebitis was lower in the polyurethane, in which the catheter was placed at lower angle, almost parallel to the vessel. Our results will aid in developing new catheters and in improving PIVC-securement techniques.

Low-temperature infiltration identified using infrared thermography in patients with subcutaneous edema revealed ultrasonographically: A case report.

Infiltration is a frequent complication of infusion therapy. We previously demonstrated the usefulness of infrared thermography as an objective method of detecting infiltration in healthy people. However, whether thermography can detect infiltration in clinical settings remains unknown. Therefore, we report two cases where thermography was useful in detecting infiltration at puncture sites. In both cases, tissue changes were verified ultrasonographically. The patients were a 56-year-old male with cholangitis and a 76-year-old female with hepatoma. In both cases, infiltration symptoms such as swelling and erythema occurred one day after the insertion of a peripheral intravenous catheter. Thermographic images from both patients revealed low-temperature areas spreading from the puncture sites; however, these changes were not observed in other patients. The temperature difference between the low-temperature areas and their surrounding skin surface exceeded 1.0°C. Concurrently, ultrasound images revealed that tissues surrounding the vein had a cobblestone appearance, indicating edema. In both patients, subcutaneous tissue changes suggested infiltration and both had low-temperature areas spreading from the puncture sites. Thus, subcutaneous edema may indicate infusion leakage, resulting in a decrease in the temperature of the associated skin surface. These cases suggest that infrared thermography is an effective method of objectively and noninvasively detecting infiltration.

Using Ultrasonography for Vessel Diameter Assessment to Prevent Infiltration.

Small veins are a risk factor for infiltration. However, there are no data regarding the ideal vein diameter for preventing infiltration. Using ultrasound, vessel diameter and calculated ratios of the vessel diameter to the catheter gauge were measured. The relationship between the ratio and infiltration was assessed to establish a cutoff point. The mean ratio of the infiltration group was significantly smaller than that of the no-infiltration group (P < .01), and the ratio was an independent risk factor according to the multivariable analysis. The ratio of 3.3 was determined to be the cutoff point that enables health care professionals to identify veins appropriately.

The relationship between the tip position of an indwelling venous catheter and the subcutaneous edema.

The present observational study aimed to clarify the relationship between the tip position of an indwelling venous catheter and the subcutaneous edema using ultrasonography images. Data were obtained before catheter removal in a medical ward of a university hospital in Tokyo, Japan. Two hundred peripheral intravenous catheters (PIVCs) from 154 patients were observed just before removal. We analyzed data for 194 PIVCs from 150 patients. Subcutaneous edema was observed in 43.8% of ultrasonography images. According to the univariate analysis, insertion site, PIVC tip contact with the vessel wall, and irritant drug's presence were selected as independent variables for logistic regression analysis. Both irritant drug and PIVC tip contact were associated with the presence of subcutaneous edema [adjusted odds ratio (OR) = 2.68, 95% confidence interval (CI) = 1.14-6.33; and OR = 2.01, 95% CI = 1.04-3.88, respectively]. To the best of our knowledge, this is the first study to use ultrasonography to simultaneously observe PIVC tip position and subcutaneous edema. Using ultrasonography to observe PIVC may be a useful method to understand these mechanisms. Medical staff should select an appropriate vein and indwelling catheter to avoid contact of PIVC tip with the vessel wall. Further studies exploring the causality of the relationship between subcutaneous edema, catheter placement, and thrombus formation is required. In addition, further development of nursing skills and medical devices to reduce mechanical stress is required.