a b s t r a c t

Objective: The purpose of this pilot study was to investigate whether use of a guidewire improves suc- cessful placement of ultrasound-guided peripheral IVs (PIV) in difficult intravenous access patients in the emergency department (ED).

Methods: This was an unblinded, prospective, randomized trial performed by emergency medicine (EM) clinicians at a single academic ED. Eligible participants were randomized to ultrasound-guided PIV place- ment with or without the use of a guidewire. PIV access was obtained using the AccucathTM 20 gau- ge x 5.7 cm catheters by way of deployment or non-deployment of the guidewire. Primary outcome measure was First-pass success rate and secondary outcomes included number of attempts, complication rates, and clinician reported ease of insertion.

Results: Seventy patients were enrolled and 69 were included in the final analysis. Thirty-four partici- pants were randomized to use of guidewire and 35 to no guidewire. first-pass success rates were similar with and without guidewire use, 47.1% vs. 45.7%, (p = 0.9). There were no differences found in median number of attempts between the two techniques, 2 (IQR 1-2) vs 2 (IQR 1-2), (p = 0.60). The complication rates were similar, 15% vs. 29% (p = 0.25). Clinicians reported no difference in ease of insertion between methods on a 5-point Likert Scale, mean 2.6 vs 2.7 (p = 0.76).

Discussion: In this pilot study comparing ultrasound-guided PIV placement in ED patients using an inte- grated guidewire versus no guidewire, there was no significant difference in first-pass success, number of attempts, or complication rates. This study provides preliminary data for further investigations.

(C) 2019

Introduction

Obtaining peripheral intravenous (PIV) access is essential to providing Emergency medical care for many patients. Establishing timely and reliable PIV access in the emergency department is cru- cial for concurrently completing investigations and acute manage- ment of patients who present with a broad spectrum of illness. peripheral intravenous catheters are first line for many of these

* Corresponding author.

E-mail addresses: [email protected] (H.K. Cochrane), phenwood@bwh. harvard.edu (P.C. Henwood), [email protected] (E. Platz), ailandry@bwh. harvard.edu (A. Landry), [email protected] (O. Baker), hkimberly@bwh. harvard.edu (H.H. Kimberly).

patients and are often placed in superficial veins using visual and tactile landmarks alone. However, in some patients, placing a PIV using landmarks may be challenging or ultimately unsuccessful for a number of reasons [1-3].

Point-of-care ultrasound can be utilized to guide PIV placement in patients with difficult PIV access [2,4,5] and has been shown to be superior to landmark-based approaches in patients with antici- pated difficult access [6-8]. While the ultrasound (US)-guided PIV technique is successful in many difficult PIV access patients, it has reported Failure rates on first attempt between 16 and 44%, and infiltration rates of up to 8% in the first hour after placement [2,8-10]. Although failure of PIV placement, both with and without ultrasound, is likely multifactorial, one of the challenges is thread- ing the catheter successfully into the vein. The modified Seldinger

https://doi.org/10.1016/j.ajem.2019.07.022

0735-6757/(C) 2019

technique, utilizing a guide-wire to thread the catheter, is a poten- tial technique to improve success rates of US-guided PIV [10-13]. However, to our knowledge, there are no prior randomized trials in the ED setting specifically comparing this technique to standard placement on difficult access patients.

The goal of this pilot study was to compare success rates of US- guided PIV, with and without the use of a guidewire, in a prospec- tive randomized trial of participants in an emergency department (ED) setting. The primary endpoint was first-time success rates. Secondary outcomes included number of attempts, complication rates and clinician reported ease of insertion.

Methods

This prospective, randomized pilot study compared US-guided PIV with and without a guidewire at a single urban, academic ter- tiary medical center with an annual census of over 65,000 patients. The study took place between February 2015 and March 2018 with a pause of 11 months’ time period awaiting a catheter shipment. Inclusion criteria were: adult patients undergoing evaluation in the ED with difficult peripheral IV placement defined by 2 or more failed attempts at standard landmark PIV insertion by nursing staff. Participants were excluded if they were determined to need cen- tral or intraosseous access, had contraindications to PIV placement in upper extremities, or were unwilling or unable to provide con- sent to participate in the study. Informed consent was obtained from all study participants prior to enrollment. The study protocol was approved by the local institutional review board.

Study procedure

All ultrasound-guided PIVs were placed by emergency medicine (EM) clinicians with previous training in US-guided PIV including EM residents, attending physicians, and physician assistants . All EM clinicians received previous training in US-guided PIV based on the ACEP guidelines [14] and routinely placed US- guided PIV during patient care prior to the study. Prior to the study, EM clinicians participated in a 30-minute training session specific to the integrated guidewire catheter prior to study initiation which included three PIV placements on a gel block phantom. Once iden- tified and enrolled by study physicians, participants were random- ized to the use of guidewire or no guidewire using random number generation (www.randomizer.org) though numbered opaque and sealed assignment envelopes.

The technique for US-guided PIV in both groups involved initial identification of patent target veins, at the discretion of the per- forming clinician, using a high-frequency linear transducer with one of three available ultrasound systems in the ED: SonositeTM M Turbo (Bothell, WA, USA), MindrayTM M9 (Shenzen, China), or Phi- lipsTM CX50 (Amsterdam, Netherlands). The area over the target vessel was sterilized topically and allowed to dry for 30 s. The lin- ear transducer was covered with a vaso-occlusive dressing and sterile lubricant used as a gel medium. Both groups used the Accu- cathTM 20 Ga x 5.7 cm integrated catheter system, in order to stan- dardize the procedure as much as possible in both groups and limit confounders. Those randomized to the use of the guidewire, deployed the wire and advanced the catheter over the wire. Those randomized to the group without the guidewire, used the identical system though did not deploy the guidewire prior to advancing the catheter. At our institution, providers generally cannulate in short- axis although this was not specified in the protocol. Ultimately the technique (short versus long axis) as well as potential use of lido- caine (rare in our institution) were left to provider discretion.

successful cannulation was defined as return of blood in the

catheter along and the ability to flush and administer fluids or

medications through the PIV as documented by the clinician. Demographic data, pertinent medical history, details about the placement attempt(s) including number of attempts, PIV location and PIV placement complications (hematoma, Arterial puncture, dislodgement, PIV infiltration or other) during the ED visit were collected on a standardized form. In addition, clinicians were asked to rate ”ease of the technique” on a 5-point Likert scale with 1 as the easiest, and 5 most difficult. An attempt was defined as a skin puncture and was reported by the clinician performing the PIV. Similarly, complications during PIV placement and the duration of the ED visit were noted on the standardized data collection form by the providers.

The primary outcome measure of the study was the proportion of successful cannulations with one skin puncture (first-pass suc- cess). Secondary outcomes were the number of overall attempts, complication rates, between the two techniques, and clinician satisfaction.

Sample size calculation and statistical analysis

The sample size calculation was based on review of prior liter- ature including a large randomized trial that found a 42% differ- ence in first attempt success between AccucathTM and standard catheters in landmark-based PIV placement [18]. Assuming a First attempt success rate of 90% for the guidewire group and 60% in the non-guidewire group, the calculated sample size per group was n = 35 (power = 0.8, alpha = 0.05).

t-tests on the equality of means and Fischer’s exact tests were used to compare baseline characteristics of participants, as well as individual complications between the guidewire and non- guidewire groups. Patients were assigned indicator variables for each complication to account for cases with multiple complica- tions per patient. Fischer’s exact test was used when comparing small demographic and clinical subgroups. We used Pearson’s chi-square test to compare first-pass success rates between guide- wire and non-guidewire groups. All tests were two-sided. We used the Wilcoxon rank-sum (Mann-Whitney) test to compare the med- ian number of attempts between guidewire and non-guidewire groups. Alpha of 0.05 was considered statistically significant. Anal- yses were performed with StataMP 13 (College Station, TX).

Results

A total of 72 participants were screened with 70 enrolled and 69 analyzed. One participant assigned to the guidewire deployment group was excluded due to insufficient data recorded by the clini- cian who performed the procedure. Thirty-four participants under- went guidewire assisted PIV placement and 35 without guidewire use. (see Fig. 1). Baseline characteristics of participants by study group are shown in Table 1. The groups were similar with respect to age, race, or suspected reason for difficult PIV access, however a larger proportion of women were randomized to the guidewire group. Ultrasound-guided peripheral PIV was performed by 51 dif- ferent clinicians. Of the clinicians 64.7% were EM residents (45% randomized to wire and 54% to no wire), 23.5% were PAs (61% ran- domized to wire and 38% to no wire), and 11.6% EM attendings (46% randomized to wire, 53% to no wire). Each clinician enrolled a mean of 1.37 (SD 0.85) patients. US-guided PIV target vein loca- tion was at clinician discretion. 11% were placed in the forearm, 43% in the antecubital fossa (AC), and 46% in the medial upper arm. First-pass success rates were similar using the guidewire, 47.1%, compared to no guidewire, 45.7% (p = 0.9). We found no difference in the number of attempts between using the guidewire, median 2 (IQR 1-2) and no guidewire groups median 2 (IQR 1-2) (p = 0.60). There were no differences in the number of complications during

Fig. 1. Study flowsheet.

Table 1

Baseline demographics and relevant medical conditions of participants. Relevant medical conditions were obtained at the time of the visit from review of the active

Table 2

Complication rates during IV attempts and the duration of the ED visit as reported by enrolling clinicians.

problem list and supervising physician opinion on reason for difficult IV access.

Abbreviations: end stage renal disease (ESRD), intravenous drug use (IVDU). Complications Guidewire (n = 34) No guidewire (n = 35) p-value

Caucasian, n (%)	13 (39%)	17 (55%)	0.31
African American, n (%)	15 (45%)	12 (39%)	0.62
Other/mixed, n (%)	5 (15%)	2 (6%)	0.43	trial comparing ultrasound-guided PIV placement with and with-
Relevant medical conditions, n (%) out the use of an integrated guidewire in ED patients with difficult

Characteristics	Guidewire	No guidewire	p-value		Hematoma	3.0% (n = 1)	8.6% (n = 3)	0.61
	(n = 34)	(n = 35)			Arterial puncture	0% (n = 0)	2.9% (n = 1)	1.00
Age, years (mean)	51.4	50.6	0.80	Dislodgement IV infiltration		9.1% (n = 3) 3.0% (n = 1)	2.9% (n = 1) 8.6% (n = 3)	0.35 0.61
Female sex, n (%) Race	29 (83%)	19 (56%)	0.02	Other		0% (n = 0)	5.7% (n = 2)	0.49

Obesity	11 (31%)	17 (50%)	0.15
Dehydration	8 (23%)	12 (35%)	0.30
Edema	4 (11%)	4 (12%)	1.0
Chemotherapy	4 (11%)	6 (18%)	0.51
ESRD	5 (14%)	8 (24%)	0.37
IVDU	4 (11%)	3 (9%)	1.0
Other	12 (33%)	6 (18%)	0.17

the ED visit between use of guidewire, mean 15%, and no guide- wire, mean 29% (p = 0.25)(Table 2). Clinicians reported no differ- ence in ease of insertion on a 5-point Likert scale between guidewire mean 2.6, and no guidewire mean 2.7, p = 0.76.

Discussion

In this prospective randomized pilot study, comparing ultrasound-guided PIV placement with or without a guidewire in ED patients with reported difficult access, we found no significant difference in first-pass success rates between using an integrated guidewire versus no guidewire. In addition, number of attempts, complication rates, and perceived ease of insertion were similar for both techniques. To our knowledge, this is the first randomized

PIV access and provides pilot data for future larger studies in this area. This study used ED clinicians with variable experience, including physician assistants, whom to our knowledge have not previously been studied performing ultrasound-guided PIV using integrated guidewires which may improve generalizability, although the study was not powered to evaluate differences between Experience levels.

These overall results demonstrating no benefit to using an inte- grated guidewire for PIV placement, are consistent with recently published literature [16,19]. A 2017 study in an outpatient inter- ventional radiology population used nurses to perform landmark guided PIV placements and found no significant difference between the use of an integrated guidewire and standard insertion technique for first-pass success, number of attempts, or patient satisfaction [16]. Similarly, Boniface and colleagues previously compared the use of an integrated guidewire device with conven- tional catheters using ultrasound guidance in 25 healthy volun- teers with no significant difference in success rates or first pass attempts [15]. In contrast, a study using army combat medics per- forming landmark PIV placement demonstrated higher success rates with standard catheters rather than the integrated guide- wires [19]. These results differ from a randomized trial of inpa- tients comparing Nurse performed landmark PIV placement

which found a 42% improvement in first-pass success rates using an integrated guidewire compared to standard catheters [18]. In addition to differences in patient populations and clinician experi- ence, most studies compared the integrated guidewire with a stan- dard catheter which are typically different lengths. In our study, we used the same manufacturer, gauge, and length of catheter in both the guidewire and no guidewire group in order to control for these potential confounders.

Results from this study differ from prior literature in that over- all first-time success rates were lower than previously published [7,10,21]. For example, Chick et al. noted first-pass success rates of 77% guidewire and 82% conventional, though their patient pop- ulation differed from ours as the study was conducted in an outpa- tient interventional radiology clinic without predefined difficult access or complicating factors inherent to the emergency depart- ment environment [16]. Raio et al. also noted 77% success on the first attempt with guidewire, and all had a 100% success rate within three attempts [21]. A prior study of nurse performed ultrasound-guided PIVs in patients with difficult PIV access demonstrated first-pass success rates of 41%-71% [10]. There are a number of possible reasons why first attempt success was lower than other published studies. A majority of the clinicians enrolling were residents and PAs. Although all clinicians in our ED have training in ultrasound-guided PIVs and use them routinely in prac- tice, the results may have been impacted by variable experience levels. In addition, this study was likely impacted by a patient pop- ulation with predefined difficult access who had already failed landmark attempts which differs from the study population in some of the published literature [17]. Clinicians in this study had relatively limited training with the new integrated catheter, having practiced only on a gel block simulator prior to enrolling patients. It is possible that success rates may have increased with additional experience with the novel integrated catheter system. With 51 dif- ferent clinicians performing PIVs in this study, most clinicians per- formed only one to two procedures. However, because the novel catheter was used in both arms of the study, challenges due to lack of familiarity with the device should have affected both arms sim- ilarly. While first-pass success rates were lower than some prior reports, these results may be more generalizable to the real-life acquisition of a new technique with a broad range of clinician experience in the ED setting. This study was not powered to eval- uate whether an integrated guidewire system would be more use- ful for beginners versus advanced clinicians, which could be an area for further investigation.

The location of target vessel was at the discretion of the individ-

ual clinician. Although the majority of PIVs were placed in the antecubital fossa and upper arm, clinicians were not asked to spec- ify the vessel nor were data collected on the size or depth of the vessel. Prior literature suggests differing success rates of ultrasound-guided PIV placement and infiltration between basilic and brachial veins [1,20]. Further studies in larger cohorts could evaluate if the Seldinger technique is beneficial for certain veins, or in certain patient populations.

Limitations

This was a single center study with a small number of patients enrolled. A sample size calculation was performed based on litera- ture suggesting high rates of success using a guidewire and thus this study may be underpowered to detect smaller differences in success rates. The study was underpowered for subgroup analysis of novice vs experienced providers or learning curves. Although efforts were made to approach all potential participants during the study physician available periods, some may have been missed creating a convenience sampling bias. Another potential limitation is that this study was completed at an academic institution with

the availability of dedicated ultrasound faculty to supervise PIV placement which could impact the overall generalizability of this study. Although unlikely, it is possible that ultrasound faculty could have unconsciously supervised the two groups differently. We utilized a large pool of clinicians including EM attendings, fel- lows, residents and PAs with a wide range of overall ultrasound proficiency and comfort in using ultrasound as an adjunct to pro- cedural placement of PIVs. Data on prior overall ultrasound experi- ence or prior total number of US-guided PIV placed was not collected. The large heterogeneous group of enrolling providers may explain the lack of difference and lower success rates than predicted. Patient satisfaction or time to placement as metrics for ease of use was not evaluated, nor did we obtain data regarding the depth or size of the target vessels or dwell time after the ED visit. Data, including number of attempts and complications, were self-reported by the performing clinician who was not blinded to the technique which could be a source of bias.

Conclusion

In this randomized single-center pilot study comparing ultrasound-guided PIV placement in ED patients with difficult access, there was no significant difference in first-pass success, number of attempts, or complication rates using an integrated guidewire compared to no guidewire. This preliminary data should be replicated in larger studies and further investigations are war- ranted to evaluate for possible differences between provider expe- rience, learning curves, and success rates using a guidewire technique.

Funding

This study was supported by a resident grant from the Mas- sachusetts College of Emergency Physicians (2015D001918) (VK and HHK). Dr. Platz is supported by a grant from the National Heart, Lung and Blood Institute (K23 HL123533). All other authors report no additional conflicts in relation to this manuscript.

Declaration of Competing Interest

Authors reported no conflict of interest.

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