The effect of needle size on cerebrospinal fluid collection time and post-dural puncture headache: A retrospective cohort study.

OBJECTIVE: The main objective of this study was to compare cerebrospinal fluid (CSF) collection time and patient's discomfort between 20G (a)traumatic and 22G atraumatic needles. BACKGROUND: Risk of post-dural puncture headache (PDPH) is decreased using atraumatic needles. Smaller needles may give lower risk but possibly at the cost of increased CSF collection time (due to lower flow), leading to additional patient's discomfort. METHODS: We performed a retrospective study of lumbar puncture data from a research program on CSF metabolomics and compared traumatic 20G (n = 210) with atraumatic 20G (n = 39) and 22G (n = 105) needles. In this cohort, incidence of PDPH was prospectively registered with other procedure details. Primary outcome was CSF collection time (time to fill the tube). Secondary outcomes were pain and stress scores during procedure, and incidence of PDPH. RESULTS: The time to collect 10 mL of CSF was longer for 22G needles (6.1 minutes; 95% CI 5.8-6.5) than for 20G traumatic (2.2 minutes; 95% CI 2.1-2.2) and 20G atraumatic needles (2.9 minutes; 95% CI 2.8-3.1). There were no differences in pain and stress scores. PDPH was lower for 22G atraumatic needles: odds ratio 0.41 (95% CI 0.25-0.66) versus 20G traumatic needles and 0.53 (95% CI 0.40-0.69) versus 20G atraumatic needles. Absolute PDPH rates were 69/210 (32.9%) for 20G traumatic, 13/39 (33.3%) for 20G atraumatic, and 19/105 (18.1%) for 22G atraumatic needles. CONCLUSIONS: CSF collection time is slightly longer for smaller 22G needles, but this does not lead to more discomfort for the patient.

A Comparative Study of 22G versus 19G Needles for EUS-Guided Biopsies for Parenchymal Liver Disease: Are Thinner Needles Better?

BACKGROUND AND AIMS: Data on comparative efficacy of various available endoscopic ultrasound-guided liver biopsy (EUS-LB) needles are limited. We sought to compare the performance of a novel Franseen-tip 22G fine-needle biopsy (FNB) device to that of 19G needle platforms for liver parenchyma. METHODS: Consecutive patients referred for EUS and suspected to have hepatic parenchymal disease underwent EUS-LB using different EUS needles and were included in this retrospective study. Two blinded expert liver pathologists independently reviewed and reported on: total number of tissue fragments, length of longest fragment, number of complete and incomplete portal tracts (CPT and IPT), and specimen adequacy. RESULTS: A 22G Franseen-tip needle (A) was used in 30 patients; 19G Tru-Cut needle (B) in 50 patients; 19G reverse beveled non-Tru-Cut needle (C) in 27 patients; and a 19G flexible non-Tru-Cut needle (D) in 28 patients. In the order of needles, A, B, C and D, > 10 tissue fragments were obtained in 100%, 6%, 82%, and 96% samples, the mean number of CPTs was 6.9; 3.0; 7.3; and 16.9, length of longest fragment was 3.8, 4. 7, 3.9, and 8.4 mm, and specimen adequacy was 66.7%, 46%, 82.1%, and 81.5%, respectively. A positive correlation was obtained between number of CPTs and length of longest fragment in samples accrued by 19G needles. CONCLUSION: EUS-LB specimens using 22G Franseen-tip needle appear highly fragmented, leading to inferior specimen adequacy compared to 19G non-Tru-Cut needles. We also report on using length of longest fragment as an additional criterion for specimen adequacy as it positively correlates with number of CPTs standard.

Needle Manufacturing, Quality Control, and Optimization for Patient Comfort.

INTRODUCTION: There is an increasing rise of cosmetic injectables. We sought to understand the manufacturing, quality control process, and needle selection of hypodermic needles for fillers. OBJECTIVE: To understand the process of manufacturing and quality control of hypodermic needles and the relevance to an aesthetic clinician. METHODS: We conducted a search of the internet and contacted medical device companies to understand the manufacturing process. We then collaborated with the Executive director of global pharmaceutical technology from Abbvie as well as the packaging and device engineer at Galderma and summarized our findings. Finally, we reviewed the literature and summarized existing recommendations on techniques to minimize pain related to injection. RESULTS: Hypodermic needles undergo an extensive manufacturing and regulatory process. Many considerations are taken into account in needle manufacturing as well as the selection process with commercially available hyaluronic acid filler products. Needle manufacturers are held to universal standards though the International Organization for Standardization (ISO). Filler companies perform their own testing to evaluate suitability of needles for their product including leakage force, penetration force, extrusion force, etc. Finally, parameters such as needle length, needle diameter, and wall thickness are considered for selection of needle/hub with individual filler viscosity. CONCLUSION: There is extensive consideration that goes into needle manufacturing, quality control, and optimization for hyaluronic acid filler. Understanding the technical process helps inform the clinician and guide patient care for maximum comfort. J Drugs Dermatol. 2021;20(1):44-48. doi:10.36849/JDD.5591.

An overview on the advantages and limitations of 3D printing of microneedles.

The use of 3D printing (3DP) technology, which has been continuously evolving since the 1980s, has recently become common in healthcare services. The introduction of 3DP into the pharmaceutical industry particularly aims at the development of patient-centered dosage forms based on structure design. It is still a new research direction with potential to create the targeted release of drug delivery systems in freeform geometries. Although the use of 3DP technology for solid oral dosage forms is more preferable, studies on transdermal applications of the technology are also increasing. Microneedle sequences are one of the transdermal drug delivery (TDD) methods which are used to bypass the minimally invasive stratum corneum with novel delivery methods for small molecule drugs and vaccines. Microneedle arrays have advantages over many traditional methods. It is attractive with features such as ease of application, controlled release of active substances and patient compliance. Recently, 3D printers have been used for the production of microneedle patches. After giving a brief overview of 3DP technology, this article includes the materials necessary for the preparation of microneedles and microneedle patches specifically for penetration enhancement, preparation methods, quality parameters, and their application to TDD. In addition, the applicability of 3D microneedles in the pharmaceutical industry has been evaluated.

Endoscopic Ultrasound-Guided Fine Needle Biopsy Using 22-Gauge Franseen Needle for the Histological Diagnosis of Solid Lesions: A Multicenter Prospective Pilot Study.

BACKGROUND: Recently, a novel 22-gauge needle with three symmetric needle points and crown-shaped cutting heels, known as a Franseen needle, has been developed for endoscopic ultrasound-guided fine needle biopsy (EUS-FNB). AIM: To assess the histological material acquisition rate and histological diagnostic capability of the 22-gauge Franseen needle (AC22) during EUS-FNB for solid lesions. METHODS: This study was designed as an open-label, multicenter, prospective, single-arm pilot study of EUS-FNB using AC22 for the diagnosis of solid lesions. Three passes of FNB using AC22 were performed for all lesions. The primary endpoints were the histological material acquisition rate and histological diagnostic capability. The secondary endpoints were the technical success rate, quality of histological samples, number of passes for diagnosis, and safety. RESULTS: Between September 2017 and May 2018, 75 patients were enrolled. The final diagnoses were malignancy in 65 and benign in 10. Three passes of FNB were technically successful in all patients. The sensitivity, specificity, and accuracy for the malignancy of histological analyses were 92.3% (60/65), 100% (10/10), and 93.3% (70/75), respectively, for the first pass and 95.4% (62/65), 100% (10/10), and 96% (72/75), respectively, for combined three passes. The diagnostic yield plateaued after the second pass. Sufficient tissue samples for histological interpretation were obtained in 96% (72/75) and 100% (75/75) patients for the single pass and combined three passes, respectively. Two patients (2.7%) developed mild pancreatitis as an adverse event. CONCLUSION: EUS-FNB using AC22 showed high histological diagnostic capability with the high first pass yield. CLINICAL TRIALS REGISTRY: UMIN Clinical Trials Registry (UMIN ID: UMIN000036641).

19 G nitinol needle versus 22 G needle for transduodenal endoscopic ultrasound-guided sampling of pancreatic solid masses: a randomized study.

BACKGROUND: The aim of this prospective multicenter study was to compare a flexible 19 G needle with nitinol shaft (19 G Flex) with a standard 22 G needle for transduodenal endoscopic ultrasound (EUS)-guided sampling of pancreatic head tumors. METHODS: Patients with pancreatic head tumors requiring tissue diagnosis were randomized into two arms: puncture with either a 19 G Flex needle or a 22 G needle. The primary end point was diagnostic accuracy for malignancy. The secondary end points were ergonomic scores, sample cytohistological quality, and complications. A 6-month follow-up was performed. RESULTS: 125 patients were randomized and 122 were analyzed: 59 patients in the 19 G Flex arm and 63 patients in the 22 G arm. The final diagnosis was malignancy in 111 patients and benign condition in 11. In intention-to-treat analysis, the diagnostic accuracy for malignancy of the 19 G Flex and 22 G needles was 69.5 % (95 % confidence interval [CI] 56.1 % - 80.8 %) vs. 87.3 % (95 %CI 76.5 % - 94.4 %), respectively (P = 0.02). In per-protocol analysis excluding eight technical failures in the 19 G Flex group, the diagnostic accuracy of the 19 G Flex and 22 G needles was not statistically different: 80.4 % (95 %CI 66.9 % - 90.2 %) vs. 87.3 % (95 %CI 76.5 % - 94.4 %; P = 0.12). Technical success was higher in the 22 G arm than in the 19 G Flex arm: 100 % (95 %CI 94.3 % - 100 %) vs. 86.4 % (95 %CI 75.0 % - 94.0 %), respectively (P = 0.003). Transduodenal EUS-guided sampling was more difficult with the 19 G Flex (odds ratio 0.68, 95 %CI 0.47 - 0.97). CONCLUSION : The 19 G Flex needle was inferior to a standard 22 G needle in diagnosing pancreatic head cancer and more difficult to use in the transduodenal approach.

Residual strain effects in needle-induced cavitation.

Needle-induced cavitation (NIC) locally probes the elastic and fracture properties of soft materials, such as gels and biological tissues. Current NIC protocols tend to overestimate properties when compared to traditional techniques. New NIC methods are needed in order to address this issue. NIC measurements consist of two distinct processes, namely (1) the needle insertion process and (2) the cavitation process. The cavitation process is hypothesized to be highly dependent on the initial needle insertion process due to the influence of residual strain below the needle. Retracting the needle before pressurization to a state in which a cylindrical, tube-like fracture is left below the needle tip is experimentally demonstrated to reduce the impact of residual strain on NIC. Verification of the critical cavitation pressure equation in this new geometry is necessary before implementing this retraction NIC protocol. Complementary modeling shows that the change in initial geometry has little effect on the critical cavitation pressure. Together, these measurements demonstrate that needle retraction is a viable experimental protocol for reducing the influence of residual strain, thus enabling the confident measurement of local elastic and fracture properties in soft gels and tissues.

Comparison of the Diagnostic Performance of Newly Designed 21-Gauge and Standard 22-Gauge Aspiration Needles in Patients with Solid Pancreatic Masses.

BACKGROUND: Although endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) has been widely used for the diagnosis of pancreatic tumors, the ability to obtain adequate pancreatic tumor tissue needs to be improved. AIMS: This study was performed to compare a newly designed 21-gauge needle (EUS Sonopsy CY; Hakko Medical, Nagano, Japan) and a standard 22-gauge needle for tissue sampling of solid pancreatic masses. METHODS: Consecutive patients with solid pancreatic masses who underwent EUS-FNA with either the EUS Sonopsy CY or the 22-gauge needle from June 2014 to December 2016 were enrolled. The primary outcome was comparison of the diagnostic yield of the FNA samples. The secondary outcomes were comparison of technical success, diagnostic ability for malignancy, and complications. RESULTS: A total of 93 patients (40.9% female; mean age, 70.1 years) underwent EUS-FNA with the EUS Sonopsy CY (n = 47) or the standard 22-gauge needle (n = 46). The technical success rate was 100% in both groups, and the overall diagnostic accuracy for malignancy was similar between the groups (100% in the EUS Sonopsy CY group vs. 95.7% in the 22-gauge needle group, P = 0.242). Nevertheless, the EUS Sonopsy CY resulted in significantly higher scores for cellularity (P = 0.006) and lower scores for blood contamination (P < 0.001). The procedure-related complication rate was comparable between the groups (P = 0.148). CONCLUSIONS: The EUS Sonopsy CY provided higher-quality specimens for histological evaluation in terms of both sample cellularity and blood contamination for the diagnosis of solid pancreatic masses. TRIAL REGISTRATION: The study was registered in a clinical trial registry, No. UMIN000032598.

Single-needle: an effective alternative to dual-needle peripheral access in therapeutic plasma exchange.

Apheresis treatments, which involve the removal of a component of blood, generally require one access and one return line to continuously draw and return blood into the extracorporeal circuit. At our center, we prefer to use peripheral venous access to avoid central line-related complications, especially infection. Motivated by patient-centered care, the single-needle (SN) option for therapeutic plasma exchange (TPE) offered on the Spectra Optia (Terumo BCT, Lakewood, CO) was evaluated. Five patients underwent procedures using both SN and dual-needle (DN) plasma exchange procedures using the Spectra Optia. TPE procedures ran a median of 51 (range:10-102) minutes longer using the SN-TPE option. Inlet flow rates, plasma removal efficiency, and incidence of citrate reactions were similar between SN- and DN-procedures. Patients reported great satisfaction with SN-TPE.

Comparing Combined Short-Axis and Long-Axis Ultrasound-Guided Central Venous Catheterization With Conventional Short-Axis Out-of-Plane Approaches.

OBJECTIVE: Visualizing the needle tip using the short-axis out-of-plane (SA-OOP) ultrasound-guided central venous catheterization approach is difficult and results in posterior wall puncture (PWP). To improve needle tip visualization in the long-axis view, combining the SA-OOP and the long-axis in-plane approaches has been suggested. The authors, who previously reported on the utility of this technique using a manikin model, examined the feasibility of this novel method (referred to as the combined short-axis and long-axis [CSLA] approach) and compared the CSLA approach with the SA-OOP approach in humans for the present study. DESIGN: Prospective observational study. SETTING: Single institution, Rakuwakai Otowa Hospital. PARTICIPANTS: Patients undergoing cardiac or vascular surgeries. INTERVENTIONS: The CSLA and SA-OOP approaches were used for ultrasound-guided right jugular venous puncture. The puncturing procedures were determined arbitrarily preoperatively without consideration of the patient's neck anatomy and were based on the operator's preference without randomization. MEASUREMENTS AND MAIN RESULTS: The study comprised 100 patients. Successful guidewire insertion without PWP was performed in 48 patients (96%) in the CSLA approach group and 33 (66%) in the SA-OOP approach group; the rate was significantly higher in the CSLA approach group (p = 0.0001). The procedural durations were 27.5 (range 17.0-122.0) seconds in the CSLA approach group and 25.0 (range 15.0-158.0) seconds in the SA-OOP approach group (p = 0.19). CONCLUSIONS: This study showed that the CSLA approach to ultrasound-guided central venous catheterization might help prevent PWP.

Just-in-Time Training for Intraosseous Needle Placement and Defibrillator Use in a Pediatric Emergency Department.

OBJECTIVES: Just-in-time training (JITT) is a method of simulation-based training where the training occurs within the clinical environment in a concise manner. Just-in-time training has shown effects at the learner, patient, and system-wide levels. We evaluated a JITT curriculum for the procedures of intraosseous (IO) needle placement and defibrillator use in a pediatric emergency department (ED) by comparing the trainees' comfort level in performing those procedures independently (Kirkpatrick level 2a) and trainees' knowledge of the procedures/equipment (Kirkpatrick level 2b) before and after the JITT. METHODS: The study enrolled all fourth year medical students and residents (family medicine and pediatrics) who rotated through a children's hospital ED. The JITT curriculum included group discussion on storage locations of procedure equipment in the ED and clinical indications/contraindications followed by hands-on procedure training. One of 2 attending physicians facilitated the 10- to 20-minute JITT in the ED during their shifts. Trainees completed an anonymous survey to delineate medical training level, previous procedure experiences, procedure-related knowledge, and comfort level to perform the procedures independently. Identical surveys were completed before and after the JITT. The data were analyzed using percentage for categorical variables. For comparisons between pre-JITT and post-JITT survey data, χ tests or Fisher exact tests were used. RESULTS: There were 65 surveys included (34 pre-JITT and 31 post-JITT surveys). The comfort level to perform procedures independently increased from pre-JITT 0% to post-JITT 48% (P < 0.001) for IO needle placement and from pre-JITT 3% to post-JITT 32% (P = 0.0016) for defibrillator use. The procedure-related knowledge also increased by ##greater than or equal to 50% post-JITT (P < 0.0001). CONCLUSIONS: Our JITT curriculum significantly increased the comfort level of the trainees to perform IO needle insertion and defibrillator use independently. Procedure-related knowledge also increased. By increasing their comfort to perform these procedures independently, we aim to increase the likelihood that trainees can be competent contributing members of an acute medical response team in these respective roles.

Transdermal Microneedles-A Materials Perspective.

Transdermal drug delivery is an emerging field in the pharmaceutical remit compared with conventional methods (oral and parenteral). Microneedle (MN)-based devices have gained significant interest as a strategy to overcome the skin's formidable barrier: the stratum corneum. This approach provides a less invasive, more efficient, patient friendly method of drug delivery with the ability to incorporate various therapeutic agents including macromolecules (proteins and peptides), anti-cancer agents and other hydrophilic and hydrophobic compounds. This short review attempts to assess the various materials involved in the fabrication of MNs as well as incorporation of other excipients to improve drug delivery for novel medical devices. The focus will be on polymers, metals and other inorganic materials utilised for MN drug delivery, as well as their application, limitations and future work to be carried out.

Effect of Beam Steering on Echogenic and Nonechogenic Needle Visibility at 40°, 50°, and 60° Needle Insertion Angles.

Currently, there is little understanding of the role of echogenic needles and beam steering at moderate angles of needle insertion. The ultrasound images of the echogenic and nonechogenic needles inserted into pork at 40°, 50°, and 60° were scored by anesthesiologists on a scale of 0-10. The effect of different levels of beam steer was also explored. At 40°, steep beam steering improves visualization of both nonechogenic and echogenic needles to an equal, satisfactory level. At 50° and 60°, visualization of nonechogenic needles is poor, whereas visibility of an echogenic needle was adequate and may be improved with steep beam steering.

Spread of fluid: Role of tip configurations in needles.

BACKGROUND/PURPOSE: During the injection of a fluid in a tissue model, the fluid might be affected by the needle tip configuration and the number of channels. Thus, the objective of the present work is to observe the influence of different needle tips and number of channels on the spread of a fluid. METHODS: Fluid distribution data were obtained after injecting 0.3 mL of fluid into a foamed polymer model with a velocity of 2 mm/s. The spread area and the depth were determined for 3 different types of hypodermic needles: Single channel needles with bevel tip and blunt tip and a needle with conical tip and 3 internal channels. RESULTS: The bevel tip provides a higher spread in the direction where the bevel points and reaches larger depths than the other two needles. The spread for the blunt tip and the polymer needle is equally distributed on both sides of the needle. The largest horizontal area around the tip is achieved by the 3-channel needle. CONCLUSION: The tip configuration and number of channels have an influence on the distribution of fluid. The bevelled needle directs the fluid and reaches larger depths compared with the 3-channel needle that gets more horizontal spread.

Assessing the sharpness of hypodermic needles after repeated use.

Four gauges (14G, 16G, 18G, 20G) of single use hypodermic needles were evaluated for sharpness by measuring the force required to puncture rehydrated bovine leather. The needles began to dull after 1 use with maximum bluntness occurring within 4 to 5 uses.

Évaluation du tranchant des aiguilles hypodermiques après un usage répété. Quatre gabarits (14G, 16G, 18G, 20G) d'aiguilles hypodermiques à usage unique ont été évalués pour le tranchant en mesurant la force requise pour percer du cuir bovin réhydraté. Les aiguilles ont commencé à s'émousser après 1 usage et la capacité de tranchant maximale se produisait durant les 4 ou 5 premières utilisations.(Traduit par Isabelle Vallières).

Dynamic Ultrasound-Guided Short-Axis Needle Tip Navigation Technique for Facilitating Cannulation of Peripheral Veins in Obese Patients.

This preliminary observational study evaluated a specific ultrasound technique for venous access. Ultrasound was utilized for navigating a needle and catheter within the vessel lumen after venopuncture. One hundred adult obese surgical patients without visible vessels on their upper extremities were enrolled. Forty-five different operators ranging from medical students to attending anesthesia faculty performed venous cannulation with the specific ultrasound technique. Veins in 95 patients were cannulated successfully on the first attempt. This ultrasound-guided protocol facilitates navigation of both the catheter and needle within a vessel, increasing the first-attempt success rate of peripheral venous cannulation in adult obese patients.

Strength of commonly used spinal needles: the ability to deform and resist deformation.

We investigated the strength of commonly used spinal needles in relation to the amount of deformation, and registered forces during standardised testing. We investigated differences between manufacturers for the same length and gauge of Luer and non-Luer needles, and examined the effect of the internal stylet in terms of needle strength. A specialised rig was designed to perform the testing in both the horizontal and axial plane, reflecting common industrial tests and clinical use. Needles from four commonly used manufacturers were used (Vygon, Becton Dickinson, B Braun, and Pajunk). Needles of 25 G and 27 G were tested in 90-mm and 120-mm lengths. We found significant differences in terms of the size of final deformation and 'toughness'/resistance to deformation between needles of different brands. There were also significant differences between horizontal tests conducted as an industry standard and our own axial test. This may have bearing on clinical use in terms of the incidence of bending and breakage. The presence of the internal stylet resulted in significantly greater toughness in many needles, but had little effect on the degree of deformation. Comparison of Luer and non-Luer needles of the same brand and size showed few significant differences in strength. This result is reassuring, given the imminent change from Luer to non-Luer needles that is to occur in the UK.

Effect of Microneedle Type on Transdermal Permeation of Rizatriptan.

The present study was aimed to investigate the effect of salient microneedle (MN) geometry parameters like length, density, shape and type on transdermal permeation of rizatriptan (RIZ). Studies were carried out using two types of MN devices viz. AdminPatch® arrays (ADM) (0.6, 0.9, 1.2 and 1.5 mm lengths) and laboratory-fabricated polymeric MNs (PMs) of 0.6 mm length. In the case of the PMs, arrays were applied three times at different places within a 1.77-cm2 skin area (PM-3) to maintain the MN density closer to 0.6 mm ADM. Histological studies revealed that PM, owing to their geometry/design, formed wider and deeper microconduits when compared to ADM of similar length. Approximately 4.9- and 4.2-fold increases in the RIZ steady-state flux values were observed with 1.5 mm ADM and PM-3 applications when compared to the passive studies. A good correlation between different dimensionless parameters like the amount of RIZ permeated (C t /C s), thickness (h/L) and surface area (S a/L 2) of the skin was observed with scaling analyses. Numerical simulations provided further information regarding the distribution of RIZ in MN-treated skin after application of different MNs. Overall, the study suggests that MN application enhances the RIZ transdermal permeation and the geometrical parameters of MNs play an important role in the degree enhancement.

Fabrication, Physicochemical Characterization, and Performance Evaluation of Biodegradable Polymeric Microneedle Patch System for Enhanced Transcutaneous Flux of High Molecular Weight Therapeutics.

A revolutionary paradigm shift is being observed currently, towards the use of therapeutic biologics for disease management. The present research was focused on designing an efficient dosage form for transdermal delivery of α-choriogonadotropin (high molecular weight biologic), through biodegradable polymeric microneedles. Polyvinylpyrrolidone-based biodegradable microneedle arrays loaded with high molecular weight polypeptide, α-choriogonadotropin, were fabricated for its systemic delivery via transdermal route. Varied process and formulation parameters were optimized for fabricating microneedle array, which in turn was expected to temporally rupture the stratum corneum layer of the skin, acting as a major barrier to drug delivery through transdermal route. The developed polymeric microneedles were optimized on the basis of quality attributes like mechanical strength, axial strength, insertion ratio, and insertion force analysis. The optimized polymeric microneedle arrays were characterized for in vitro drug release studies, ex vivo drug permeation studies, skin resealing studies, and in vivo pharmacokinetic studies. Results depicted that fabricated polymeric microneedle arrays with mechanical strength of above 5 N and good insertion ratio exhibited similar systemic bioavailability of α-choriogonadotropin in comparison to marketed subcutaneous injection formulation of α-choriogonadotropin. Thus, it was ultimately concluded that the designed drug delivery system can serve as an efficient tool for systemic delivery of therapeutic biologics, with an added benefit of overcoming the limitations of parenteral delivery, achieving better patient acceptability and compliance.

A randomized crossover study comparing a novel needle guidance technology for simulated internal jugular vein cannulation.

BACKGROUND: Despite ultrasound guidance for central line placement, complications persist, as exact needle location is often difficult to confirm with standard two-dimension ultrasound. A novel real-time needle guidance technology has recently become available (eZono, Germany) that tracks the needle during insertion. This randomized, blinded, crossover study examined whether this needle guidance technology improved cannulation of a simulated internal jugular (IJ) vein in an ultrasound phantom. METHODS: One hundred physicians were randomized to place a standard needle in an ultrasound neck phantom with or without the needle guidance system. Video cameras were placed externally and within the lumens of the vessels to record needle location in real time. The primary outcome measured was the rate of posterior wall puncture. Secondary outcomes included number of carotid artery punctures, number of needle passes, final needle position, time to cannulation, and comfort level with this new technology. RESULTS: The incidence of posterior vessel wall puncture without and with needle guidance was 49 and 13%, respectively (P < 0.001, odds ratio [OR] = 7.33 [3.44 to 15.61]). The rate of carotid artery puncture was higher without needle navigation technology than with needle navigation 21 versus 2%, respectively (P = 0.001, OR = 12.97 [2.89 to 58.18]). Final needle tip position being located within the lumen of the IJ was 97% accurate with the navigation technology and 76% accurate with standard ultrasound (P < 0.001, OR = 10.42 [2.76 to 40.0]). Average time for successful vessel cannulation was 1.37 times longer without guidance technology. CONCLUSION: This real-time needle guidance technology (eZono) shows significant improvement in needle accuracy and cannulation time during simulated IJ vein puncture.