Which Needle Gauge Corresponds With the Smallest Needle Size
Cardiovasc Intervent Radiol. Author manuscript; available in PMC 2013 Apr 28.
Published in final edited class as:
PMCID: PMC3638030
NIHMSID: NIHMS451687
Syringe and Needle Size, Syringe Blazon, Vacuum Generation, and Needle Control in Aspiration Procedures
Luke J. Haseler
1Griffith Health Found, Griffith Academy, Gold Coast, Australia
Randy R. Sibbitt
twoSectionalisation of Interventional Radiology, Helena Pain Middle, Helena MT, USA
Wilmer Fifty. Sibbitt, Jr.
3Section of Internal Medicine, Academy of New Mexico Health Sciences Eye Albuquerque, NM, USA
Adrian A. Michael
3Department of Internal Medicine, University of New Mexico Wellness Sciences Center Albuquerque, NM, USA
Charles Yard. Gasparovic
4MIND Institute at the Academy of New Mexico, University of New Mexico Health Sciences Heart Albuquerque, NM, U.s.
Arthur D. Bankhurst
3Department of Internal Medicine, Academy of New United mexican states Health Sciences Center Albuquerque, NM, USA
Abstract
Purpose
Syringes are used for diagnostic fluid aspiration and fine needle aspiration biopsy (FNA) in interventional procedures. Nosotros adamant the benefits, disadvantages, and patient safety implications of syringe and needle size on vacuum generation, hand force requirements, biopsy/fluid yield, and needle control during aspiration procedures.
Materials and Methods
Unlike sizes (one, three, 5, 10, and twenty ml) of the conventional syringe and aspirating mechanical safety syringe, the reciprocating procedure device (RPD), were studied. 20 operators performed aspiration procedures with the following outcomes measured: one) vacuum (Torr), 2) time to vacuum (seconds), three) hand force to generate vacuum (Torr-cm2), 4) operator difficulty during aspiration, 5) biopsy yield (mg), and 6) operator command of the needle tip position (mm).
Results
Vacuum increased tissue biopsy yield at all needle diameters (p < 0.002). 20 ml syringes achieved a vacuum of −517 Torr, but required significantly more force to aspirate, and resulted in significant loss of needle control (p<0.002). The x ml syringe generated merely xv% less vacuum (−435 Torr) than the 20 ml, and required much less paw force. The mechanical syringe generated identical vacuum at all syringe sizes with less hand force (p<0.002), and provided significantly enhanced needle command (p<0.002).
Conclusions
To optimize patient safety and control of the needle and maximize fluid and tissue yield during aspiration procedures, a ii-handed technique and the smallest syringe size adequate for the procedure should be used. If precise needle control or one-handed operation is required, a mechanical safe syringe should be considered.
Keywords: Syringe, Safety, Aspiration, Complications, FNA, Needle
Introduction
Aspiration of body fluids and fine needle aspiration biopsy (FNA) with suction provided by a syringe are important diagnostic procedures in interventional medicine [ane–ix]. In the field of FNA, there is considerable controversy regarding the employ of capillary action with vacuum versus vacuum provided by syringe, and if vacuum is used, the optimal size of syringe for aspiration procedures with operators usually recommending larger syringes sizes - a ten ml, 20 ml, or even larger devices [9–14]. For fluid aspiration procedures, the syringe is sized according the amount of fluid anticipated, or in the instance of a syringe as a needle introducer is sized in the 3 ml to 10 ml range. All the same, the size of the aspiration syringe is left to the discretion of the physician, and the choice of syringe size is often based on the feel, preparation, and prejudices of the operator [i–8].
The pick of syringe size should be based on the known effects of syringe size on the strength of vacuum generation, the forcefulness required to generate a specific level of vacuum, the difficulty to generate vacuum, the volume of fluid to be aspirated or the required biopsy yield, needle command, and patient safety considerations [i–13]. Although biopsy or fluid yield is important, patient safety and the known complications of needle aspiration must exist considered, including hemorrhage, hematoma, pneumothorax, and respiratory abort [15–21]. The Joint Commission, the Needlestick Prophylactic and Prevention Deed, the Occupational Safe and Health Assistants (OSHA), the Patient Safety and Quality Improvement Act of 2005, and Veterans Assistants National Center for Patient Safety and relevant national and international organizations concerned well-nigh prophylactic all urge physicians to maximize patient safety during invasive procedures, including integration of rubber technologies [22–28].
Patient safety in needle procedures include maintenance of a sterile field using disposable medical supplies if possible, exclusion of patient drug allergies, careful attention to anesthesia protocols, recognition and correction of coagulation status, correct patient/operative site confirmation, pre-puncture interrogation of the target with the imaging modality to ascertain operative anatomy, post-procedure observation and care, compulsive labeling, custody, and processing of the biopsy sample, careful needle control during and after the procedure, and prompt recognition of complications [22–28]. In the nowadays randomized-controlled study trial, we compared a conventional syringe to a mechanical procedure syringe and examined the effect of syringe size on aspiration procedures including hand force required to aspirate, biopsy yield, vacuum generation capabilities, and command of the needle tip, all which accept direct relevance to patient safety.
Materials and Methods
Subjects
This project was in compliance with the Helsinki Announcement and was approved by the institutional review board (IRB). Subject confidentiality and privacy was protected according to the Wellness Insurance Portability and Accountability Deed (HIPAA). This clinical trial is registered at clinicaltrials.gov; the registration number is {"type":"clinical-trial","attrs":{"text":"NCT00651625","term_id":"NCT00651625"}}NCT00651625. After informed consent, xx operators who regularly perform diagnostic aspiration procedures were asked to perform a protocol of aspiration procedures with the various sizes and types of procedure syringes and needles with the following outcomes measured 1) quantitative levels vacuum (negative pressure) measured in Torr (mm Hg) two) time to achieve a certain degree of vacuum, 3) hand forcefulness required to pull the plunger to achieve a certain degree of vacuum, 4) difficulty in generating maximum vacuum with the various sizes, and v) ability of the operator to command the needle tip position while aspirating. The operators were experienced with the conventional syringe, and novices to the mechanical syringe. Each operator performed each syringe maneuver with each variable 10 times with the order of each maneuver randomized to eliminate the possibility of a consistent bias and to minimize the impact of any preparation effect.
Syringes
The conventional syringes were the 1 ml, iii ml, 5 ml, 10 ml, and 20 ml Luer-Lot BD syringe (Ref 309604, Becton Dickinson & Co., Franklin Lakes, NJ 07417). This syringe was used in both a 1-handed and two-handed technique. The mechanical syringe, the reciprocating process device (RPD) ( Figure one ), was too provided in the ane ml, 3 ml, 5 ml, ten ml, and xx ml sizes (RPD) (RPD-1, RPD-3, RPD-5, RPD-x, RPD-20, AVANCA Medical Devices, Inc, 600 Central Ave SE, Ste 232, Albuquerque, New United mexican states, 87102, The states. tele: 505. 243.4600 website: world wide web.AVANCAMedical.com) [29,30]. The mechanical syringe was used in a one-handed fashion. The RPD mechanical syringe has two barrels, 2 plungers, and a mechanical linkage betwixt the plungers – a caster system – that permit the plungers to reciprocate. Thus, the index and heart fingers do not change position, only the thumb moves from one plunger to the other to move between aspiration and injection. This creates an extremely stable aspiration-injection device that can hands generative vacuum or pressure level [29,thirty].
Different Sizes of Reciprocating Procedure Device (RPD)
The RPD mechanical syringe (i ml, 3 ml, 5 ml, 10 ml, and xx ml RPD) device injects when the thumb presses the dominant plunger and aspirates when the accessory plunger is pushed. The alphabetize and middle fingers practise not alter position on the finger flanges when transitioning from injection to aspiration.
Vacuum Generation
Vacuum (negative pressure) was measured in each syringe with a digital pressure meter with male person Luer fittings (DPM-2000 Digital Force per unit area Meter, BC Group, Chicago, IL). A female:female luer adaptor was used to attach the male luer lock fitting of the syringes to the male luer lock fitting of the pressure meter. Vacuum (negative pressure) was measured in Torr (mm Hg) and equally expressed at Torr below ambience pressure level. For certain experiments Torr was measured as a office of time or as a part of displacement of the plunger of the aspirating syringe. Four different needles were used to determine the upshot of needle diameter on vacuum generation, a 27 gauge 1 inch needle, a 25 judge i.five inch needle, a 21 approximate 6 cm needle, and a 22 gauge 10 cm needle (BD, ane Becton Drive, Franklin Lakes, NJ 07417, website: http://www.bd.com). For the needle experiments a depression dead space female luer adapter with a silicone rubber port was fastened to the force per unit area meter, and the silicone rubber seal was penetrated by the needle then that vacuum at the needle tip could be directly measured. 10 measures were made at each needle gauge and plunger displacement and fourth dimension form determined to maximum vacuum attained at each plunger displacement, each corresponding to the volume measures on the syringe barrel.
The Outcome of Vacuum and Needle Diameter on Biopsy Yield
Fine needle biopsy in ex vivo liver was performed using 3 unlike gauges of biopsy needles with or without vacuum as follows: 22 gauge (22ga × 15 cm, Disp Chiba Biopsy Needle, Cook, Bloomington, IL) and 17 and 19.5 guess (Percut 17 ga X 15 cm Biopsy Needle, True cat No. N715, and xix.five ga X 10 cm Percut Cut-Biopsy Needle, Cat No. N910, EZEM, Inc, Westerbury, NY) with one) vacuum and no vacuum using a 10 conventional syringe, and 2) vacuum and no vacuum using the 10ml RPD syringe. Needle biopsies were performed by a single operator in a randomized fashion between each needle size with and without vacuum until 10 biopsies with each needle size with and without vacuum were performed. Using these needles, the needle tip was placed through the hepatic capsule, the stylet removed, and the syringe device attached. Biopsies were performed with no vacuum (0 Torr) or maximum vacuum (approximately −441 Torr). After each individual biopsy procedure, the biopsy needle was removed, air was placed into the mechanical or conventional syringe, and the sample expelled and weighed in a digital precision balance and the result expressed in milligrams (mg) of tissue.
Forcefulness Required to Generate Vacuum
Strength required to pull the plunger of a conventional syringe or push the aspiration plunger of a mechanical syringe to a particular degree of vacuum was calculated by the measured vacuum (pressure) multiplied times the cantankerous exclusive surface area of the inner barrel of the syringe device (surface expanse = π r2), where r = 1/2 the inner diameter of the barrel. Strength was expressed in Torr-cm2.
Difficulty in Generating Vacuum
The difficulty in generating maximum vacuum was determined by the ability of the operator to generate maximum vacuum with a particular device size using i hand, and was expressed as a percentage of individuals able to generate maximum vacuum for each syringe and RPD size.
Precise Measurement of Syringe and Needle Control by the Physician
The clinically validated quantitative needle-based displacement procedure model was used to precisely measure syringe and needle control by the private doctor ( Figure ii ) [29,xxx]. In this measurement organization, a layer of 1.3 cm thick open cell flexible polystyrene foam simulates the target tissue. A rigid polystyrene marker is placed on the needle to a preset indelible marking on the needle, and then the needle is advanced into the target surface until the needle tip is at the desired location and polystyrene marker is touching the surface. The dr. operator then performs the aspiration procedure. Loss of command in the forward direction (penetration) pushes the polystyrene mark posteriorly on the needle past the indelible marker, permitting precise measurement in mm of loss of control in the forward direction. Each operator performed10 procedures with each size of the conventional syringe with 1 hand, ten procedures each with each size of the conventional syringe with 2 easily, and 10 procedures with each size of the RPD with one hand, randomized equally between the 1, 3, five, 10, and 20 ml devices.
Linear Displacement Method for Measuring Syringe and Needle Control
A rigid polystyrene marker is placed on the needle to a preset indelible mark on the needle, and so the needle is avant-garde into the target surface until the needle tip is at the desired location and polystyrene marker is touching the surface. The physician operator and then performs the aspiration process. Loss of command in the forward direction (penetration) pushes the polystyrene mark posteriorly on the needle by the indelible mark, permitting precise measurement in mm of loss of control in the forrad management.
Statistical Assay
Data were entered into Excel (Version 5, Microsoft, Seattle, WA), and analyzed in SAS (SAS/STAT Software, Release half dozen.11, Cary, NC). Differences in chiselled information were determined with Fisher's Verbal Test and differences in parametric information with the t-test, while differences between multiple parametric data sets were determined with Fishers Least Pregnant Difference Method. Corrections were made for multiple comparisons. Correlations between parametric information were determined with logistic regression and between non-parametric data with Spearman correlation and Kendall rank method. Corrections were made for multiple comparisons.
Results
The effects of device size on vacuum generation are shown in Figures 3 and 4 . The human relationship of vacuum to volume displacement of the plunger was non-linear and asymptotic for larger syringe and RPD sizes (20 ml, 10 ml, and five ml), and nearly linear for the smaller syringes and RPDs (three ml, i ml). As can exist seen in Figures 3 and 4 , the conventional syringe and RPD generated statistically identical vacuum: plunger displacement curves for each syringe size (p>0.9). Thus, size for size the conventional syringe and the RPD mechanical syringe generated the identical vacuum at the same level of plunger displacement. The maximum vacuum possible with each the syringe and RPD was dependent on syringe size: the 20 ml syringe and RPD (−517±12 Torr maximum vacuum), the 10 ml (− 441±11 Torr maximum vacuum), the 5 ml (−334±eight Torr maximum vacuum), the 3 ml (−250±7 Torr maximum vacuum), and the 1 ml (−120±half dozen Torr maximum vacuum). Thus, syringe and RPD size had a pregnant effect on the strength of vacuum generated, with the xx ml syringe and RPD each generating a maximum vacuum of approximately −517 Torr.
Vacuum Generation with the Conventional Syringe
Vacuum in Torr (mm Hg) are shown every bit a function of plunger displacement and syringe size. As tin can be seen each syringe size has its unique vacuum - plunger displacement curve with the 20 ml syringe generating the greatest vacuum. However, along each curve, the plunger displacement to a particular volume generates the identical vacuum regardless of syringe size.
Vacuum Generation with the Reciprocating Procedure Device (RPD)
Vacuum in Torr (mm Hg) are shown as a function of plunger displacement and RPD size. Every bit tin can be seen each RPD size has its unique vacuum - plunger displacement curve with the xx ml device generating the greatest vacuum; however, the curves generated with the RPD are identical to those with the conventional syringe - thus the RPD and conventional syringe are identical in vacuum-generation characteristics.
However, the 10 ml syringe and 10 ml RPD both generated about −441 Torr vacuum, which was only 15% less than the −517 Torr generated by the corresponding 20 ml devices ( Figures three and iv ). Thus, a flattening of the vacuum:book displacement of the plunger curves occurred at the 10 ml displacement in both the ten ml and the 20 ml devices where there was a precipitous asymptote after which further plunger displacement resulted in but a minimal increase in vacuum (fifteen%) despite an additional 10 ml (100%) of plunger displacement (100%). Therefore, there is a diminishing render in terms of vacuum generation where vacuum levels off asymptotically after the 10 ml plunger displacement with very lilliputian boosted vacuum generation to xx ml plunger displacement. Between different sizes of syringes, the strength of vacuum at the same plunger volume displacement was identical; thus, the xx ml syringe and RPD syringe both generated approximately −250 Torr at the 3 ml marker, as did the 10 ml, five ml, and three ml devices. Similarly, each generated approximately −334 Torr at the five ml plunger displacement mark. The strength of vacuum was solely determined by the volume displacement of the plunger at all syringe and RPD sizes; therefore, larger syringes only generate more maximum vacuum than smaller syringes when the volume deportation of the plunger is greater.
The effects of needle diameter and vacuum on biopsy yield are shown in Table i . The use of vacuum markedly increased the yield of biopsy textile (75% to 150%, depending on needle size) (p<0.01). In add-on, larger needles provided much more than biopsy specimen than did smaller diameter needles ( Table i ). The syringe and the RPD each provided essentially the aforementioned biopsy yield, consequent with the largely identical vacuum generation characteristics every bit shown in Figures 3 and four . The upshot of needle bore on vacuum generation at the needle tip is shown in Effigy 5 , and was essentially identical for both the syringe and the RPD (P>0.5). Larger needle sizes (21 g and 22 chiliad) permitted about instantaneous generation of vacuum at the needle tip (approximately one second to maximum vacuum); even so, small needle diameters (25 thou and 27 grand) delayed the development of maximum vacuum at the needle tip, not fully equalizing for approximately three to 3.5 seconds ( Effigy v ).
Vacuum Generation as a Function of Needle Diameter
Vacuum in Torr (mm Hg) are displayed equally a function of time with 4 different needle diameters (measured in judge) using a 20 ml RPD to generate vacuum. As can be seen, smaller diameters of needles take a lag time of several seconds before generation of maximum vacuum.
Table ane
Biopsy Yield equally a Function of Needle Diameter and Vacuum
| Needle Bore (gauge) | Fine Needle Non-Aspiration Biopsy (FNNA) Biopsy Yield (mg) (no vacuum −0 Torr) n = 10 | Fine Needle Aspiration Biopsy (FNA) Biopsy Yield (mg) (vacuum-441 Torr ) n = 10 | Increment in Biopsy Yield | 95% Conviction Interval | Significance |
|---|---|---|---|---|---|
| 17 Gauge -10 ml Syringe | 9.iii± 3.i mg | 23.7± 5.0 mg | 155% | 113% to 197% | P ≤ 0.0001 |
| 17 Gauge -10 ml mechanical syringe | nine.5± 3.0 mg | 24.1± 6.1 mg | 153% | 106% to 201% | P ≤ 0.0001 |
| 19.5 Approximate -10 ml Syringe | v.1± 1.nine mg | eight.9± 2.1 mg | 75% | 38% to 111% | P ≤ 0.002 |
| 19.five Gauge -ten ml mechanical syringe | 5.0± 2.i mg | 9.one± 1.9 mg | 82% | 44% to 120% | P ≤ 0.002 |
| 22 Judge -10 ml Syringe | 1.6± 0.6 mg | 2.viii± 0.7 mg | 75% | 37% to 113% | P ≤ 0.002 |
| 22 Approximate -ten ml mechanical syringe | 1.vi± 0.7 mg | two.nine± 0.6 mg | 81% | 43% to 119% | P ≤ 0.002 |
The actual strength required to pull a plunger on a mechanical syringe to a particular level of vacuum is shown in Figure six and, like vacuum generation, was identical betwixt the conventional syringe and the RPD size by size (p >0.v). The relationship between the level of vacuum and strength required to distract the plunger was largely linear within a specific size of syringe or RPD, merely demonstrate markedly different and unique slopes between each individual syringe and RPD size ( Figure half-dozen ). Chiefly, the force to generate a predefined level of vacuum was markedly dissimilar between the diverse device sizes with vacuum being developed with minimal forcefulness with the smaller devices, simply requiring much more force with the larger devices. For example, to generate the maximum vacuum in a iii ml syringe or RPD (approximately −253 Torr) requires a force of 800 Torr-cm2 to maintain the plunger at the 3 ml book displacement mark; in contrast to generate the same vacuum (approximately −253 Torr) with a 20 ml syringe at the three ml plunger displacement mark requires iv.25 times more than force (3400 Torr-cm2). Similarly, although the xx ml syringe or RPD can develop a15% greater maximum vacuum than the corresponding 10 ml device, the 20 ml devices require almost double the strength (185%) − 7600 Torr-cm2 versus 4150 Torr-cm2 to generate this vacuum ( Figure six ). Therefore, a larger caste of vacuum is achieved only past using markedly more force to generate this vacuum. The force required to generate equivalent levels of vacuum of a small syringe with a large syringe are 2 to five times larger, requiring greater hand and arm strength, and thus, more force on the syringe.
Vacuum Generation as a Part of Strength
Vacuum in Torr (mm Hg) are displayed as a function of force required to displace the plunger to various volumes. The solid line represents the about-linear relationship of vacuum to forcefulness for each syringe or RPD size. The fine dotted lines demonstrate the force required to generate maximum vacuum with a particular syringe size. The bold dotted lines indicate the corresponding force necessary to generate the same level of vacuum with the twenty ml RPD or syringe. Equally tin be seen, information technology requires much more force to generate the same level of vacuum with larger syringes.
To measure private difficulty in generating vacuum, nosotros determined the ability of 20 operators to generate maximum vacuum with each size of the conventional syringe and each size of the RPD biopsy device using i-hand, which is often used during aspiration procedures, and is a validated mensurate of difficulty in operating a particular syringe device [29,30]. Effigy 7 demonstrates the difficulty of generating the aforementioned level of vacuum with the different sizes of syringe and RPD. As tin can exist seen, 100% (20/20) of individuals could generate maximum vacuum with one paw using either the 1 ml syringe or the one ml RPD (p= 0.5). However, with the x ml syringe but 20% of subjects (four/20) could generate maximum vacuum (−441 Torr), while 100% of subjects (20/twenty) could generate the same maximum vacuum (−441 Torr) using the 10 ml RPD (p<0.0001). Notably, 0% of subjects (0/20) could generate maximum vacuum with 20 ml syringe using one hand, while 95% (19/20) could generate the aforementioned maximum vacuum (−517 Torr) with the RPD (p<0.001).
Operator Difficulty Generating Maximum Vacuum
Vacuum in Torr (mm Hg) are displayed as a percentage of individuals able to generate maximum vacuum (fine dotted horizontal lines) with a particular syringe or RPD size. The conventional syringe is the bold dotted line, and the RPD the solid bolded line. Every bit can be seen, it is much easier for operators to generate high level of vacuum with the RPD compared to a conventional syringe due to the pulley mechanism of the RPD.
Thus, although the RPD and conventional syringes generate identical vacuum size-past-size, information technology is far easier to generate the same vacuum with the RPD than with the conventional syringe because of the mechanical advantage provided by the pulley machinery. Because information technology is easier to generate vacuum in smaller size syringes than larger syringes and in the RPD relative to the conventional syringe, it would be predicted that both syringe and needle command would exist better with smaller syringes and the RPD during aspiration than large conventional syringes. Increasing syringe size had a stiff negative effect on the control of the conventional syringe whether used with one manus (r = 0.97, gradient = 2.14, 95% CI i.54 to two.76, p < .002) and when used with two hands (r = −0.98, slope = 2.16, 95% CI 1.51 to two.84, p < .002) with the worst command being with the 20 ml syringe whether used with i or two easily (p<0.005) ( Effigy 8 ).
Needle Command as a Function of Syringe Size
The undesirable characteristic of unintended forward penetration (loss of control of the needle in the forward direction) for each syringe size during aspiration procedures with the conventional syringe used with one hand is shown. The 1 ml device corresponds to a vacuum of −120 Torr, 3 ml −250 Torr, v ml −334 Torr, x ml −441 Torr, and xx ml −517 Torr. Control of the conventional syringe was improved if vacuum was generated and the device controlled with ii hands (p < 0.002), but about improved in terms of needle control with the RPD mechanical syringe (p < 0.002).
In dissimilarity, considering the RPD can generate the same level of vacuum as a syringe only can reach this more easily, control of the RPD is superior to that of the conventional syringe at all syringe sizes ( Figure 8 , p <0.01). In direct syringe to syringe comparisons, the curves in Figure 8 demonstrate that the RPD syringe operated with one mitt provides significantly better needle command (18.nine% less unintended forwards penetration) than the conventional syringe operated with two hands (hateful unintended penetration across all sizes; RPD syringe = 7.02±ane.08 mm; Conventional Syringe: 8.66±1.03 mm, p<0.001) The divergence in control betwixt the RPD and conventional syringe was even greater comparing the conventional syringe with one hand (mean unintended penetration 13.2±3.0 mm) to the RPD syringe with ane mitt (mean unintended penetration 7.02±1.08 mm) with the RPD reducing unintended forward penetration by 46.9% (p<0.001).
Give-and-take
Needle aspiration procedures to obtain torso fluids or tissue, including FNA, that apply a syringe for awarding of vacuum remain important diagnostic procedures in radiology, endocrinology, otonasolaryngology, cytopathology, cardiology, and obstetrics [1–14]. Diagnostic fluid aspiration has not inverse from the basic applied science of syringe and needle since inception. In terms of biopsy, core biopsy techniques have go increasingly popular, still, FNA techniques have not been supplanted by core biopsy; rather FNA and related aspiration techniques continue to exist important diagnostic procedures throughout medicine [3–xiv]. Some experts recommend no syringe-generated vacuum at all - the so-chosen - fine needle non-aspiration biopsy (FNNA); yet, information technology has been demonstrated that with FNNA cytopathologic yield is less in many tissues and frequently provides inadequate tissue in benign or fibrous lesions, forcing an open biopsy for a definitive diagnosis [31–34].
The recommendations for the syringe size appropriate for FNA with suction vary widely betwixt experts, just generally the 10 ml and twenty ml conventional syringes are recommended [1–14]. Certain types of needle biopsy, such a chorionic villus sample (CVS) will not piece of work at all without suction applied with a syringe [nine]. The quantity of biopsy cloth obtained by FNA or cutting needle biopsy as well varies widely between dissimilar sizes of syringe and needle with the effect of needle diameter dominating over syringe size [9–14,31,32]. The nowadays study compared FNAA to FNA with 17, 19.5, and 22 gauge biopsy needles, and plant that suction with FNA increased biopsy yield in milligrams by 155%, 75%, and 77% respectively compared to FNNA, thus, in terms of tissue yield, there is no question that FNA provides more tissue than FNNA ( Table ane ). Thus, although FNNA is certainly an established and reasonable alternative biopsy method, because of reduced tissue yield with FNNA, specially in benign lesions, many experts recommend performing both FNA and FNNA in the same private for all-time diagnostic sensitivity [1–fourteen].
Needle aspiration procedures are safer than the equivalent open techniques; however, serious complications exercise occur from needle biopsies and can exist fatal [15–18]. Needle biopsy and fluid aspiration procedures, depending on the target organ, can result in pain, bruising, arterial puncture, hematoma, exsanguination, pneumothorax, hemothorax, infection, cardiac perforation, airway compromise, and expiry, resulting in lawsuit and increased health care costs [15–21]. Thus, needle and syringe techniques, although much safer than open up techniques are non without gamble – and as the Joint Commission and other safety advocates emphasize, technologic advances that allow ameliorate control of the process device better outcomes are important to integrate into medicine to improve patient safety [22–31,35]. Better control of the syringe device during aspiration procedures has been shown to better outcomes in syringe aspiration procedures and reduce hurting and serious complications, including hemorrhage [29,30,35].
The nowadays study demonstrates that syringe size has a stiff effect on command of the needle with smaller syringes having better control and larger syringes poorer command ( Figure eight ); however, larger syringes provide more than vacuum than smaller syringes ( Figures 1 and iii ). Sandrucci et al felt that vacuum was very important to FNA techniques, and recommended even more powerful vacuum generated with larger syringes up to 60 ml [13]. In dissimilarity, Cochrane et al constitute that the 20 ml syringe was superior in terms of sample yield [9]. Similarly, Cannon et al demonstrated that different sized syringes can generate unlike levels of vacuum, and found that the 20 ml syringe provided the best overall biopsy sample yield [x]. In contrast, Yankelevitz et al reported that the same vacuum could be obtained with a 10 ml and 50 ml syringe, and felt that the 20 ml syringe was a proficient compromise to adapt dead infinite in the needle [eleven]. In practice, almost operators use a 10 ml or 20 ml syringe for FNA and similarly, about syringe pistols, handles, and guns conform either a 10 ml or xx ml syringe [fourteen]. Thus, there remains some controversy concerning the vacuum generation characteristics of the different syringe sizes [9–14].
The nowadays study specifically investigated the vacuum generation characteristics of different sizes of two unremarkably used aspiration devices: the conventional syringe and the RPD mechanical syringe ( Figures i – five ]. Every bit can be seen, for both the conventional and mechanical syringe, there were marked differences in maximum vacuum generation characteristics between the different syringe sizes. Each device size evinced a feature volume displacement-vacuum curve with increasingly not-linearity as syringe size increased ( Figures 3 and 4 ). The twenty ml syringe and 20 ml RPD generated the greatest vacuum of approximately -517 Torr, which is consistent with many recommendations for using a 20 ml device for FNA [ix–14]. However, the degree vacuum generated by the 10 ml devices was but 15% less (− 441 Torr) than the twenty ml device (−517 Torr) due to an asymptotic relationship of plunger book displacement to vacuum, thus, creating, a marginal advantage (xv%) of using a 20 ml compared to 10 ml vacuum suction device ( Figures 3 and four ). This indicates that using a 20 ml and greater device size for suction biopsy has a strong diminishing returns aspect due to the apartment asymptotic portion of the plunger deportation-vacuum generation bend which levels off asymptotically at 10 ml with very piffling gain in vacuum with further plunger displacement past 10 ml.
Although the plunger-displacement - vacuum generation curves were unique to each syringe or RPD size, the curves of the different syringe devices were related intimately to each other in terms of a specific vacuum generated for a certain volume deportation of the plunger. For example, when the plunger was displaced to the 1 ml marking on the one, 3, 5, ten, and xx ml syringe and RPD sizes, all syringe devices generated identical vacuum (approximately −120 Torr). Similarly, when the plunger was displaced to the 5 ml marking on the 5, ten, and 20 ml syringe and RPD sizes, all syringe devices generated identical vacuum (approximately −334 Torr). Therefore, all syringe devices, 1 ml through 20 ml, generate identical vacuum at the same volume displacement of the plunger.
This aspect is of import clinically: if the plunger of the 20 ml syringe or RPD is non displaced fully to the xx ml marking, there is no advantage of using the 20 ml device compared to the smaller ten ml syringe or RPD device ( Figures 3 and 4 ). As an example, many operators use a x ml or 20 ml syringe or RPD for biopsy of the breast or thyroid -but simply apply gentle vacuum to the iii or 4 ml marking. The nowadays study demonstrates there is no vacuum advantage past using the larger 10 ml or 20 ml devices with this technique, rather, a three ml or 5 ml syringe or RPD could be used to generate identical vacuum, but with functional advantages, as the 3 ml and v ml syringes and RPDs are shorter, smaller, and more hands controlled ( Figures 7 and 8 ).
Different sizes of needles amongst other factors are of import in terms of tissue yield during suction biopsy procedures [9,10,14, 31–34]. The present study demonstrated that increases in needle size produce predictable increases in tissue yield, and that application of vacuum also markedly increases tissue yield ( Tabular array 1 ). Every bit can be seen in Effigy 5 , needle size also had a marked bear upon on vacuum generation as a function of time, just not on maximum vacuum. Importantly, small needle diameters (27 estimate and 25 judge) commonly used for FNA required considerably more time to reach maximum vacuum at the needle tip every bit compared to larger needles (22 judge and 21 estimate) unremarkably used for cutting needle (for case Chiba needle) biopsy ( Figure 5 ). The implications are that when using smaller needle diameters (25 and 27 gauges) that it might exist wise to look several seconds until the vacuum at the needle tip has maximized before performing a suction biopsy maneuver in order to take total advantage of maximum vacuum at the needle tip.
Although the 10 ml or 20 ml syringe and RPD are favored past almost operators for suction biopsy because greater vacuum and sample tin can be achieved, the upshot of these larger devices sizes on command of the biopsy device and safety have not been fully discussed in the literature [1–31]. Improve control of the process device has been shown to improve outcomes in syringe aspiration procedures and reduce complications, including hemorrhage; and control of the needle tip is extremely important in FNA where complications can be astringent or even fatal [15–30]. Thus, the nowadays written report besides investigated the effect of syringe size on the operator control of the needle and syringe while generating specific levels of vacuum. As tin can exist seen in Figure 8 , operating the conventional syringe while generating maximum caused considerable loss of control in the forrad direction (p<0.001). The power of the operator to control the syringe and needle decreased progressively as syringe size increased from 1 ml to xx ml with the xx ml syringe being the worst controlled. Controlling the syringe with 2 hands or the use of the RPD mechanical syringe with i hand, markedly improved control of the needle and syringe, with the RPD being statistical superior to the conventional syringe whether used with one or two hands ( Figure 7 ).
Thus, although larger syringe sizes can generate more maximum vacuum, they are too increasingly difficult to control, and result in exaggerated unintended forward penetration (loss of command in the forward direction) that has been associated with the serious complications of syringe and needle procedures [29,xxx,35]. Thus, if a 20 ml syringe must be used, 2 hands should be used whenever possible, or, if one-handed operation or enhanced control of the needle is required, a safety mechanical like the RPD should be considered. The increasing inability to control the needle and syringe with increasing syringe size might exist due to the increasing difficulty to pull the plunger dorsum to accomplish total vacuum.
Indeed, the 20 ml device required almost twice the strength as did the 10 ml to accomplish maximum vacuum ( Figures half dozen and 7 ). Moreover, it was difficult for operators to pull dorsum the larger sizes of syringe plunger to maximum vacuum, with the bulk of operators unable to easily perform this maneuver. In dissimilarity, virtually all subjects were able to achieve maximum vacuum while controlling the needle with the 10 ml and xx ml RPD mechanical syringe because of the mechanical advantage provided past the pulley mechanism ( Figures ane , half dozen , 7 ). The Society of Interventional Radiology, the Joint Commission, the Needlestick Safety and Prevention Act, the Occupational Safety and Wellness Administration (OSHA), the Patient Safety and Quality Comeback Act of 2005, and the Veterans Administration National Middle for Patient Condom all encourage the systematic evaluation and integration of new safe methods and technologies to ameliorate health care worker and patient safety, including syringe and needle aspiration procedures such as FNA [22–28].
There are limitations to this report. Although certain of the authors before long use the RPD mechanical syringe in their own practise which would nowadays a do bias, to minimize possible bias in this study, the operators that performed the syringe procedures were consummate novices to the mechanical syringe, although experienced with the conventional syringe. The pick of operators inexperienced with the mechanical syringe created a consistent bias against the mechanical syringe, reducing differences with the conventional syringe, merely it is unlikely this would have influenced the results of the study. This is too an ex-vivo lab study that does not include the use of these devices in an actual clinical setting (i.e., no patients were biopsied). Patient safety is being extrapolated from the needle command demonstrated and may not truly interpret to the clinical setting although studies in other aspiration procedures indicate that improved needle control does interpret to less procedural hurting, improved outcomes, and fewer complications, including hemorrhage [30,35,36].
Further, other alternatives are available for aspiration other than a conventional or mechanical syringe. To better generate vacuum, syringe pistols, syringe guns, handles, and dedicated biopsy syringes have been developed [14,29,30]. A serious problem with these devices is 1) unintended forwards penetration of the needle during aspiration, a dangerous characteristic associated with increased procedural complications, including increased procedural pain and hemorrhage, 2) the expense of the device, which tin can be as much as $100 per device, and 3) the trend to reuse these devices unsterilized between patients, an unacceptable practice that contributes to infectious complications [29,35,42–47]. Another alternative is the vacuum syringe, where the plunger is locked in position past a spacer or plunger lock or the employ vacuum bottle or vacuum tube [14,29,42–47]. A trouble with these devices is expense, difficulty in transitioning from no vacuum and to vacuum at the needle tip, difficulty in release of vacuum so that the sample is not sucked from the needle into the syringe barrel, and difficulties in expelling the sample [29,42–47].
Another alterative to straight apply of a mechanical syringe is the employ of tubing between the syringe and needle, so that the needle can be held in one hand and the syringe in other or, alternatively, an assistant can generate vacuum or a vacuum syringe can exist attached to the tubing [48]. However, if there is one operator, one still has to generate vacuum with one hand which is hard with larger conventional syringes and easier with the mechanical syringe as the present study demonstrates. Furthermore, using the tubing technique, the inner diameter of the tubing and length of tubing are disquisitional in terms of deadspace that typically ranges from i.5 ml to 3 ml in pressure tubing; deadspace decreases vacuum achievable with each syringe size [49]. Using tubing with a 10 ml syringe in our laboratory, one ml, 2 ml, and 3 ml of tubing deadspace reduces vacuum doable by 13%, 20%, and 32% respectively. Using tubing with a 20 ml syringe, 1 ml, 2 ml, and 3 ml of tubing deadspace reduces vacuum doable by iii%, viii%, and 12% respectively. Vacuum intensity is probably not important for vascular admission or fluid aspiration procedures, but it is important for biopsy [14,31,38,48,l]. Thus, if the tubing technique is used, low deadspace tubing and/or a 20 ml syringe device should be used to minimize the effect of deadspace on vacuum intensity.
The RPD mechanical syringe, also known as the reciprocating syringe, is formed around the core of a traditional syringe barrel and plunger, but has an extra plunger and barrel ( Figure 1 ) [29,30]. The two plungers are mechanically linked in an opposing fashion by a caster organisation, resulting in a set up of reciprocating plungers. Thus, when the aspiration plunger is depressed with thumb, the RPD aspirates, and when the injection plunger is depressed with the pollex, the RPD injects. The characteristics of stable finger positioning, one-handed operation, the exclusive use of the flexor musculature, enhanced finger flanges with improve hand grip, the shock-absorbing qualities of the reciprocating machinery, and the absence of device lengthening permit enhanced needle control and safer, more accurate aspiration and injection procedures [29,xxx]. Mechanical syringes been demonstrated to subtract the complications of syringe and needle procedures, including hemorrhage, by 35–60% [29,thirty, 35]. Because of enhanced safety, reduced hurting, and ability to aspirate and inject with one hand, mechanical syringes are recognized past National Center for Patient Prophylactic equally a patient-safety engineering science [29,30,35–41].
The nowadays study demonstrates that larger syringes can generate significantly more vacuum than smaller syringes, but this increase in vacuum is marginal (xv%) and is associated with loss of control of the syringe and needle in the forward direction resulting in unintended frontward penetration that has been associated with the complications of syringe and needle procedures [29,30,35]. Thus, if larger syringes (x or twenty ml) are used they should either e'er be operated with 2 hands throughout the process, or if ane-handed employ, enhanced control of the needle are required, a mechanical syringe such as the RPD should be considered to make aspiration easier and to meliorate needle command. Farther, if maximum vacuum is not required for a particularly procedure, smaller syringe devices should be used to generate the same vacuum while reducing the forcefulness required and improving needle command. This written report also demonstrated that when smaller diameters of needles are used (25 gauge or 27 gauge) maximum vacuum at the needle tip is delayed past several seconds, thus, the operator should pause for a few seconds after generating vacuum before performing the biopsy to permit vacuum equilibration at the needle tip. Similarly when vacuum is released, the operator should pause for several seconds to allow the vacuum in the syringe device to return to ambient pressure then that the sample is not aspirated back into the barrel of the biopsy syringe device.
In summary, aspiration syringes have unifying physics that permit predictable generation of vacuum, but also create predictable loss of needle control and increasing difficulty in generating vacuum with larger syringe sizes. For greatest needle control, the smallest size syringe advisable for the aspiration process should be utilized (commonly a v ml or ten ml syringe), ii-hands should ever be used on the syringe device when generating vacuum during an aspiration procedure, and if i-handed operation, reduced patient pain, a larger 10 or twenty ml device, or enhanced needle control are desired, a mechanical syringe should exist considered.
Footnotes
Financial Disclosures
There was no manufacture support for this written report.
Disclosure Statement
There was no manufacture back up for this study. All devices were purchased, not donated to this report. Drs. Haseler, R. Sibbitt, Michael, Gasparovic, and Bankhurst have no potential or existent conflicts of interest in this study. Dr. Wilmer L. Sibbitt, Jr. is funded past Enquiry Grant RO1 HLO77422–01-A3 from the U.s.a. National Institutes of Health and is a full-fourth dimension professor at and an employee of the Academy of New Mexico. The University of New Mexico is the owner of the RPD mechanical syringe technology. Dr. West. Sibbitt likewise is an expert consultant for Becton Dickinson, Inc., Intelligence Management Solutions, Inc., Ferring Pharmaceuticals, Inc., Avanca Medical Devices, Inc; Avasca, Inc., and MediTech Duopross, Inc. Dr. Sibbitt holds stock in Apple tree Inc, Celgene Corp, Inc, Avanca, Inc, Avasca, Inc., Sun Microsystems, Inc, Symantec Corp, and Java, Inc. In 2009, Abbott Vascular obtained 4 patents from Dr. Sibbitt, but these do non relate to the present research.
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Which Needle Gauge Corresponds With the Smallest Needle Size
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