Prospective Study of Access Site Complications of Automated Contrast Injection With Peripheral Venous Access in MDCT

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1 Special Article Original Research Wienbeck et al. Access Site Complications in MDCT Special Article Original Research Susanne Wienbeck 1 Roman Fischbach 1,2 Stephan P. Kloska 1 Peter Seidensticker 3 Noriaki Osada 4 Walter Heindel 1 Kai U. Juergens 1 Wienbeck S, Fischbach R, Kloska SP, et al. Keywords: access site complications, contrast media, extravasation, high flow rates, MDCT DOI: /AJR Received September 30, 2009; accepted after revision February 24, Department of Clinical Radiology, University of Muenster, Albert-Schweitzer-Strasse 33, Muenster D-48149, Germany. Address correspondence to K. U. Juergens (kujuerg@uni-muenster.de). 2 Department of Radiology, Asklepios Klinik Hamburg Altona, Hamburg, Germany. 3 Bayer Schering Pharma AG, Berlin, Germany. 4 Institute of Medical Statistics, University of Muenster, Muenster, Germany. AJR 2010; 195: X/10/ American Roentgen Ray Society Prospective Study of Access Site Complications of Automated Contrast Injection With Peripheral Venous Access in MDCT OBJECTIVE. The purpose of this article is to prospectively assess the frequency and type of IV injection site complications associated with high-flow power injection of nonionic contrast medium in MDCT. SUBJECTS AND METHODS. Contrast-enhanced ( mg iodine/ml) MDCT examinations with high flow rates (up to 8 ml/s) using automatic CT injectors were performed according to standardized MDCT protocols. The location, type, and size (16 24 gauge) of IV catheters and volumes, iodine concentration, and flow rates of contrast medium were documented. Patients were questioned about associated discomfort, IV catheter sites were checked, and adverse effects were recorded. RESULTS. Prospectively, 4,457 patients were studied. The injection rate ranged from ml/s (group 1; n = 1,140) to ml/s (group 2; n = 2,536) to 5 8 ml/s (group 3; n = 781); 1.2% of the patients experienced extravasations (n = 52). Contrast medium iodine concentration, flow rates, and volumes were not related to the frequency of extravasation. The extravasation rate was highest with 22-gauge IV catheters (2.2%; p < 0.05) independently of the anatomic location. For 20-gauge IV catheters, extravasation rates were significantly higher in the dorsum of the hand than in the antecubital fossa (1.8% vs 0.8%; p = 0.018). rates were higher in older patients ( 50 vs < 50 years, 0.6% vs 1.4%; p = 0.019). Different iodine concentrations did not trigger significant differences in contrast material reactions (p = 0.782). CONCLUSION. Automated IV contrast injection applying high flow rates (i.e., up to 8 ml/s) is performed without increased risk of extravasation. The overall extravasation rate was 1.2% and showed no correlation with iodine concentration, flow rates, or contrast material reactions. Performing high flow rates with low-diameter IV catheters (e.g., 22-gauge catheters) and a location of IV catheter in the hand is associated with a higher extravasation rate. A recently updated reminder from the U.S. Food and Drug Administration reported more than 250 adverse events involving rupture of vascular access devices during power injection of contrast medium for MDCT and MRI [1]. Therefore, the use of any vascular access device without labeling for its maximum pressure is not recommended for power injection of contrast medium. With the development of CT angiography, multiphasic organ imaging, and faster delivery of IV contrast medium [2], it is important to assess critically whether extravasation and reaction rates increase proportionally with injection rates. s are a well-recognized complication associated with IV administration of contrast material during CT procedures, with an incidence rate of % [3 5]. However, data are missing about the possible incidence of and risk factors for access site complications in high-flow (i.e., 5 ml/s) power injection of contrast medium. Moreover, to our knowledge, no data exist to date about the influence of the iodine concentration of contrast medium on access site complications; increased viscosity increases the friction resistance and, hence, the pressure of the injector needed for the same flow rate. Therefore, this study aimed to prospectively assess the frequency and type of IV injection site complications associated with high-flow automatic power injection of nonionic contrast medium in MDCT. Subjects and Methods The study was approved by the institutional review board, and patients written informed consent AJR:195, October

2 Wienbeck et al. for MDCT studies was obtained. From November 2006 to February 2008, 4,457 patients were prospectively included in this study. Exclusion criteria were contraindications to iodinated contrast medium, age younger than 18 years, and the presence of a peripherally inserted central catheter, central venous line, or port-a-cath. All examinations were performed on an MDCT scanner (Somatom Definition and Volume Zoom, Siemens Healthcare) using calibrated pressure-limited flow-rate injectors (CT 2, Medtron; Stellant D, Medrad; and LF903000, Liebel-Flarsheim). Nonionic contrast material with an iodine concentration between 300 and 370 mg iodine/ml was used for CT examinations (iopromide [Ultravist 300 and Ultravist 370, Bayer Schering Pharma] and iomeprol [Iomeron 300 and Iomeron 350, Bracco Altana Pharma]). Preheated contrast material (37 C) was applied IV via power injector at rates of 1 8 ml/s. The flow rate for each individual CT study was determined by standardized MDCT protocols of our institution. The protocol for standardize MDCT included no specification of the line size for injection. Only in cases of CT angiography with flow rates up to 5 ml/s was an IV access of 22- and 24-gauge contraindicated. The injection data were categorized into three patient groups: group 1, injection rates of ml/s; group 2, rates of ml/s; and group 3, rates of 5 8 ml/s. When patients arrived in the CT area, one medical member of the CT team (resident, staff radiologist, or medical student) trained on the use of both power injectors obtained peripheral venous access or checked a preexisting venous access site, which was inserted by interns. Before examination, the peripheral IV catheters were checked by applying 5 10 ml of saline solution and were evaluated for blood return, and the connective tubing was attached to one of the power injectors. If the IV catheter could not be flushed adequately with saline before CM injection or if the patient experienced pain at the injection site, a new peripheral venous access site was inserted. Data collected included the age and sex of the patient, the specific IV catheter size (16, 18, 20, 22, or 24 gauge) and length (50, 32, 25, or 19 mm), and the type, total volume, and flow rate of contrast medium used. Additionally, the catheter location (hand, forearm, antecubital fossa, or foot) was recorded. The size and location chosen for insertion of the IV catheter was at the discretion of the CT team members, who were encouraged to use 20-gauge IV catheters whenever possible and to place IV catheters preferentially in the antecubital fossa. If venous access could not be established in the antecubital fossa, especially for patients with renal function problems who could undergo dialysis, venous access in the forearm or hand was used. The CT technologists questioned the patient during the injection about any discomfort and terminated the injection immediately if extravasation was suspected. After the examination, the injection site was carefully checked by a medical CT team member again. All patients were questioned regarding discomfort at the injection site. Any clinical complication was documented. The volume of extravasated contrast material was determined by estimating the volume of IV contrast material that had been injected and correlating this volume with the extent of swelling at the injection site. In an additional follow-up telephone interview, patients with extravasation were questioned again about subsequent symptoms at the injection site, any long-term consequences of the event, and the possible need for intervention. Adverse effects, such as nausea and emesis, sensation of warmth, hives, shortness of breath, and death, also were recorded. For all patients who had previously experienced contrast material reactions, premedication with antihistamines was applied. The regimens for giving corticosteroid prophylaxis varied greatly [6, 7]. The incidence of adverse events was recorded and correlated with the flow rate in the groups and the applied iodine concentration of contrast media. Statistical Analysis Statistical analysis was performed using SPSS software for Windows (version , SPSS, Inc.). Before statistical testing, each continuous variable was analyzed for its normal distribution (Kolmogorov-Smirnow test). Categorical variables were expressed as frequency and percentage, whereas TABLE 1: Catheter Size and Associated Episodes Catheter Size (Gauge) No. (%) of Injections Injection Rate (ml/s), Mean (Range) No. Episodes of 24 9 (0.2) 2.0 (1 3) 0 0 Rate (%) (15.6) 2.7 (1 5) ,996 (67.2) 3.0 (1 6.2) (16.7) 4.1 (1 8) (0.2) 4.8 (3 6) 0 0 continuous variables were presented as mean ± SD. The Mann-Whitney U test was used for comparison of nonparametric variables between study groups. The chi-square test and the Fisher s exact test were used to analyze categorical variables. Differences between two groups were considered significant when p was less than Results Contrast Material Injections Overall, 4457 patients (1,700 women and 2,757 men) with a mean age of 56.3 ± 15.9 years (range, years) were included in this study. The most common location of IV access was the antecubital fossa, which was used for 2,751 (61.7%) patients. The other IV access locations were the forearm (955 patients [21.4%]), the hand (725 patients [16.3%]), and the foot (26 patients [0.6%]). For 67.2% of patients (n = 2,996), a 20-gauge catheter was used; 24-gauge IV catheters were used for nine patients (0.2%), 22-gauge IV catheters were used for 696 patients (15.6%), 18-gauge IV catheters were used for 746 patients (16.8%), and 16-gauge IV catheters were used for 10 patients (0.2%) (Tables 1 and 2). Before the CT examination, 2,366 (53.1%) IV catheters were inserted by a resident or staff radiologist in the radiology department, whereas 690 (15.5%) catheters were applied by a medical student under direct supervision of a staff radiologist; 1,381 patients (31.0%) arrived with an indwelling catheter inserted by the interns, and 20 (0.4%) IV catheters had been inserted in the outpatient department (Table 1). One thousand two hundred four (27.0%) patients underwent contrast-enhanced CT of the abdomen and pelvis, 1,158 patients (26.0%) underwent CT of the chest, 253 patients underwent CT of the neck (5.7%), and 18 (0.4%) underwent CT of other body regions. CT of two or more body regions was performed for 1,155 patients (25.9%). CT angiography was done for 669 (15.0%) injections. The mean volume of injected contrast material was ± ml; 1,140 (25.6%) of the 4,457 patients were injected at rates of ml/s (group 1), 2,536 patients (56.9%) were injected at rates of ml/s (group 2), and 781 patients (17.5%) were injected at rates of 5 8 ml/s (group 3). The mean flow rate was 4.7 ml/s (Table 3). The iodine concentration applied was 300 mg iodine/ml for 443 patients. Ultravist 300 was used for 120 (2.7%) patients, and Iomeron 300 was used for 323 (7.2%) injections. However, most patients 826 AJR:195, October 2010

3 Access Site Complications in MDCT TABLE 2: Catheter Location and Associated Episodes Catheter Location No. (%) of Injections (4,014 [90.0%]) received nonionic contrast material with a higher iodine concentration (i.e., 350 mg iodine/ml [Iomeron 350; n = 1,565; 35.1%] and 370 mg iodine/ml [Ultravist 370; n = 2,449; 54.9%). Contrast Material The overall extravasation rate was 1.2% (52/4,457 patients); 27 (1.6%) episodes occurred in women and 25 (0.9%) occurred in men (p = 0.051). The mean age of patients in this group was 60.5 ± 14.2 years (age range, years). There was a significant difference in the extravasation rate between patients 50 years old or younger and patients older than 50 years (0.6% vs 1.4%; p = 0.019). The extravasation rate was 1.1% (n = 13) for group 1, 1.1% (n = 29) for group 2, and 1.3% (n = 10) for group 3, without any significant difference between the groups (p = 0.948) (Table 3). The overall mean volume of contrast material that had been injected when extravasation occurred was 68.5 ± 49.1 ml. In the three patient groups, the mean volume of extravasated contrast material was 41.3 ± 21 ml for group 1, 92 ± 51.1 ml for group 3, and 72.6 ± 53 ml for group 2 (p = 0.019). s occurred most frequently if contrast material was applied via hand veins (n = 13 [1.8%]). Other recorded extravasation sites were the antecubital fossa (n = 23 [0.8%]) and the forearm (n = 16 [1.6%]). In absolute figures, most extravasations were noticed in 20-gauge IV catheters (n = 29 [0.9%]), and significantly more extravasations occurred with IV catheters inserted into the dorsum of the hand than with those inserted in the antecubital fossa (1.8% vs 0.8%; p = 0.018). On a percentage basis, the overall extravasation rate was significantly higher with 22-gauge IV catheters (2.2%) than with 20-gauge IV catheters (1.0%) or 18-gauge IV catheters (1.1%; p < 0.05). For the comparably small groups of 24-gauge and 16-gauge catheters, no extravasation was noted either (Table 4). The frequency of extravasations was not associated with the level of experience of the No. of Episodes of Rate (%) Antecubital fossa 2,753 (61.7) Forearm 955 (21.4) Dorsum of hand 725 (16.2) Foot 26 (0.6) 0 0 medical staff inserting the venous catheter: 1.2% of extravasations occurred with medical students, 1.1% with residents or staff radiologists, and 1.3% with interns (p = 0.915). None of the extravasation episodes resulted in permanent injury to the affected extremity or necessitated surgical intervention. Contrast material extravasations were treated with elevation of the affected limb, application of cold compresses, and close clinical observation. Contrast Material Reactions Acute contrast material reactions were noticed in 35 (0.8%) patients (13 women [37.1%] and 22 men [62.9%]). The mean age of patients experiencing contrast material reactions was 48.1 ± 20.2 years (range, years). Mild reactions with nausea and or vomiting occurred in 23 (0.5%) patients without significant differences between the groups (p = 0.642). Hives were seen in 12 (0.3%) patients (p = 0.748). Moderate reactions with shortness of breath was noticed in three (0.07%) patients (p = 0.673), and severe reactions with arrhythmia requiring cardiopulmonary resuscitation was observed in two (0.05%) patients (p = 0.420) [8]. Discomfort, such as severe warmth and cold or pain, during the injection of contrast material was observed in up to 8.4% of contrast media injections. Premedication was clinically indicated in 70 patients (1.6%) revealing no contrast material reaction in this subgroup. Overall reaction rates for groups 1, 2, and 3 were 0.4% (n = 5), 0.9% (n = 24), and 0.8% (n = 6), respectively, without statistically significant differences between the groups (p = 0.272). Furthermore, different concentrations of contrast media applied did not lead to statistically significant differences in contrast material reactions (p = 0.782). Discussion Contrast Material The current study documents that automated IV contrast injection, using flow rates of up to 8 ml/s, can be performed without an increased risk of access site complications. The overall extravasation rate was 1.2% and showed no correlation with iodine concentration, flow rates, local complications, or the level of experience of the medical staff inserting the IV catheter. Previously, it had been reported that extravasation rates increase along with higher injection rates [5, 9]. At the beginning of the widespread clinical use of contrast-enhanced CT, the reported incidence for access site complications was as TABLE 3: Correlation Between Injection Rate and Contrast Material Patient Group TABLE 4: Correlation Between Cannula Size and Catheter Location and Rate Cannula Size (Gauge) Injection Rate Range (ml/s) No. of Injections No. of Episodes of Rate (%) Catheter Location Antecubital Fossa Forearm Dorsum of Hand Foot 22 4 (1.4) 5 (2.8) 5 (2.2) 0 (0) (0.7) 7 (1.2) 8 (1.9) 0 (0) 18 5 (1.0) 3 (1.8) 0 (0) 0 (0) 16 0 (0) 0 (0) 0 (0) 0 (0) Note Data are no. of episodes of extravasation (% extravasation rate). Volume of Contrast Material Extravasated (ml) Mean ± SD Range , ± , ± ± All patients 8.0 4, ± AJR:195, October

4 Wienbeck et al. low as % for flow rates of ml/s [3, 5, 9 14]. Two studies published in 1998 assessed access site complications using flow rates of 1 5 ml/s and ml/s; in 5,100 and 6,600 patients, an incidence of 0.9% and 0.6%, respectively, was reported for extravasations [3, 10]. Thus, we had hypothesized that we would find an increased frequency of extravasation due to the high infusion rates clinically used at our institution. Compared with the currently available literature, this prospective study is the first, to our knowledge, to investigate the incidence of and risk factors for access site complications applying flow rates up to 8 ml/s in a large number of individuals. The overall extravasation rate of 1.2% in our study population is slightly higher than the rates previously reported in the literature [1, 3, 5, 9 15]. However, current comparable data on the incidence of access site complications in high-flow power injection of contrast media greater than 5 ml/s are still missing. In fact, we found no increase in extravasation rate associated with higher injection rates (extravasation rates were 1.1% for group 1, 1.1% for group 2, and 1.3% for group 3). Thus, the data presented here confirm that automated IV contrast injection applying flow rates of 5 8 ml/s is a safe clinical procedure that does not cause increased access site complications. With regard to catheter position and size, significant differences in the incidence of extravasations were noted. s occurred more frequently in IV catheters placed into hand veins than in larger veins; for 20-gauge IV catheters, a significant difference between the dorsum of the hand and the antecubital fossa was noticed (1.8% vs 0.8%; p = 0.018). This finding is in line with the results of others studies showing that injections into the dorsum of the hand are significantly more frequently associated with extravasation injuries [3, 16]. All of the extravasations in the present study were mild, and the symptoms resolved completely at 1-week followup; thus, none of the patients required any intervention [17]. There seems to be a trend that, for the 22-gauge catheter, the extravasation rate is slightly higher at the same injection site than for the 20-gauge catheter. Another risk factor for an extravasation event was patient s age. Significantly higher extravasation rates were observed for patients older than 50 years (p = 0.019), a finding that is possibly explained explanation by the more fragile veins of older patients, which increases the likelihood of extravasation. Patients younger than 18 years were excluded from our study by definition [18, 19]. There was only a slight predominance of women in the extravasation group (p = 0.051). was not associated with the level of clinical experience of the medical staff inserting the IV access; 1.2% of extravasations occurred with medical students supervised by a staff radiologist, 1.1% with residents or staff radiologists, and 1.3% with interns (p = 0.915). This result might represent the high level of standardized clinical service at our institution. Although this issue was not specifically the focus of this study, it might be hypothesized that similar results will be achieved when experienced nonmedical staff apply IV catheters, as it is routinely practiced in many countries of the European Union and the United States. The literature recommends that extravasations of nonionic contrast agents with a volume of 150 ml or less should be managed conservatively without risking long-term sequelae [12]. In this study, mild extravasation injuries were seen, and the mean volume of extravasations was 68.5 ± 49.1 ml, which is comparable to results from previously published literature [3, 12, 17, 20]. There was a larger amount of extravasation (92 ± 51.1 ml) in group 3, for whom higher flow rates were applied, than in group 1 (68.5 ± 49.1 ml) and in group 2 (72.6 ± 53 ml). This finding might be explained by the higher flow rate applied, which resulted in a larger amount of extravasated volume before the extravasation was clinically recognized by the patient or medical staff and the contrast medium injection was terminated. All cases were treated conservatively according to current guidelines [7, 21 23], with elevation of the affected limb, application of cold compresses, and close clinical observation. All patients recovered entirely, and no surgical intervention was necessary. Contrast Material Reactions In the present study, the overall rate of contrast material reactions was as low as 0.8%, which is markedly lower than the results of Katayama [7] and Jacobs et al. [10], who reported overall reaction rates of 3.1% and 3.4%, respectively, for nonionic contrast material. Mild acute reactions were seen in 0.5% of patients, moderate reactions were seen in 0.1% of patients, and severe reactions were seen in 0.05% patients, without any significance between the different groups. Additionally, the results of our study indicate that the concentration of the nonionic contrast medium does not influence the overall reaction rate (p = 0.782). Contrast media agents with higher concentrations of iodine (i.e., up to 370 mg iodine/ml) do not cause more adverse events. We conclude that automated IV contrast injection applying flow rates of up to 8 ml/s can be performed without an increased risk of access site complications. The overall extravasation rate was 1.2% and showed no correlation with iodine concentration, flow rates, and local complications. However, patients age, the injection site, and the size of the inserted IV catheters were positively correlated with extravasation rates. Therefore, we recommend using a forearm or antecubital fossa for IV access, not a smaller catheter in the hand, to minimize local complications. Acknowledgments We thank the CT technologists at our institution for their very valuable help in collecting the data. References 1. US Food and Drug Administration. Reminders from FDA regarding ruptured vascular access devices from power injection. Food and Drug Administration Web site. TipsandArticlesonDeviceSafety/ucm htm. Published July 7, Updated April 30, Accessed June 14, Tschugunow A, Puesken M, Juergens KU, et al. Optimization of scan delay for routine abdominal 64-slice CT with body weight-adapted application of contrast material. 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