Development of a Cost-Effective Simulation-Based Central Line Task Trainer > The Society for Simulation in Healthcare

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Development of a Cost-Effective Simulation-Based Central Line Task Trainer

Gavin J. Lehmann MBA1; Lisa Clemens DMSc, MS, PA-C1; Kevin Pei MD, MHS-Ed, FACS1; Alton Liu MD1; Cortney Hartman MBA, CST, CRCST, CIS, FAST1; Lauren Young NREMT-P, CHSOS1; Adam Fischer MSN, RN, CHSE1; John Lozo BS, CHSOS1; Mindy Flanagan PhD2

1Parkview Health System, Advanced Medical Simulation Lab, Fort Wayne, IN
2Parkview Health System, Parkview Research Center, Fort Wayne, IN The authors listed declare no conflicts of interest.

Brief Description / Abstract:

Simulation-based central venous catheter insertion training has been well established in the literature. This training modality has been associated with reduction in overall central line associated blood stream infections (CLABSIs) and positive return on investment. Unfortunately, commercial central line trainers and consumable products require a significant capital investment and can be cost-prohibitive for organizations planning widespread implementation of simulation- based central venous catheter insertion training. A novel central venous catheter insertion task trainer was developed to address this barrier. Practicing physicians and advanced practice providers participated in simulation-based central venous catheter insertion training using both the commercial task trainer and the novel task trainer. Participants were surveyed regarding their confidence, skill, and knowledge of central venous catheter insertion pre- and post-training using both the commercial task trainer and the novel, more cost- effective task trainer created in house. Participants reported equivalent improvement in confidence, skill, and knowledge related to central venous catheter insertion using both the commercial and novel central venous catheter insertion simulation task trainers. The novel, central venous catheter insertion simulation task trainer is a replicable, more economically efficient alternative to a commercial task trainer for simulation-based clinician central venous catheter insertion training.

Introduction

The medical world is one of continuous progression, development, evolution, and transformation. Procedural training can be a costly investment for institutions.

Internal jugular (IJ) line is an important venous access that is placed to help manage many medical conditions. Traditionally this procedure is taught using anatomical landmarks for guiding the needle insertion. This technique has disadvantages because it relies on the assumption that the patient has ideal anatomy. Complications with the landmark approach are higher such as inadvertent arterial puncture, pneumothorax, and nerve injuries. Presently, the availability of ultrasound imaging equipment has made the use of this technology a standard when performing these procedures. It is essential that a physician develop the necessary skills to proficiently place the IJ line and observe methods which reduce serious complications. However, mastering this skill requires practice. This practice can be performed via simulation-based training and task trainers. Simulation-based training and task trainers are a means by which providers can perform certain tasks, for which high competence is critical, in a patient-free and repetitious environment. One of such tasks is the insertion of a central venous catheter.

Reproducing this clinical experience as cost-effectively as possible permits providers to gain invaluable repetitions in a patient-free environment while preserving budget integrity.

The availability of task trainers is expansive for the placement of central venous catheter (CVC) or central line catheter (CLC). These task trainers are highly available and have proven their value.1 While highly available, accessibility may be low; these task trainers can be cost- prohibitive, and this cost-prohibitive concern raises the need for a novel central venous catheter insertion task trainer that is effectual and cost-effective.

Related literature explores the concept of novel task trainers and their effect on training programs in recent years. Nitsche et al. identified the opportunity for a more cost-effective ultrasoundable task trainer for ultrasound-guided invasive procedures.2 Results favored the economical novel task trainer.2 Several central venous catheter and arterial line insertion and management task trainers have been produced and tested for efficacy, also with favorable results.3-5

A trend in the literature suggests a recurring need for “novel” and “low-cost” task trainers to get the job done. These motivators have driven other institutions to perform similar studies in hopes of achieving non-inferior outcomes.6 Unfortunately a gap in literature still exists with regard to a generalizable study evaluating novel, low-cost task trainers; some suggest the respective task trainer simply “shows promise” and will likely require further research.7 Chin et al. sought to validate the utility of their trainer with less emphasis on its novelty and financial partiality.8 Their study showed a statistically significant difference between pre-intervention and post- intervention confidence.8

Others, however, seek to achieve the novelty of the task trainer but have little to no interest, or at least secondary interest, in the cost of production or its subsequent savings. Lichtenberger et al. and Park et al. have developed novel task trainers without attention to cost-effectiveness.9,10 As technology and medicine advance in unison, one method of production is described in today’s world as “additive manufacturing” or “3D-printing.” This innovative means of production is turning heads, and with the knowledge to utilize it, researchers can produce various tools for training that tailor to many different areas of medicine.9 While minimizing cost may not be the primary motivator for some researchers, it is certainly achievable with this modern method.9 In the realm of 3D-printing, some researchers have increased accessibility to these tools with “negligible costs.” 10

The goal of this study is to evaluate a low-cost central line trainer created in the Mirro Advanced Medical Simulation Lab as a cost-effective solution to implement widespread central line training within the health system. This will also serve to compare a novel simulation-based training to commercial training for central line insertion on participant confidence, skill, and knowledge.

Methods

Practicing physicians and advanced practice providers participated in simulation-based central venous catheter insertion training using both the commercial task trainer and the novel task trainer. Participants were surveyed regarding their confidence, skill, and knowledge of central venous catheter insertion pre- and post-training using both the commercial task trainer and the novel, more cost- effective task trainer created in house.

A non-inferiority analysis was undertaken to demonstrate that the new Advanced Medical Simulation Lab (AMSL) training was no worse than the commercial training. Thus, this analysis uses a one-sided test with a pre-specified minimum value, above which the AMSL training was considered not inferior to the commercial training. This minimum value of score improvement for AMSL training from pre- to post-assessment was expected to be within 0.5 points (within 10% on a 5-point scale) compared to the commercial training improvement. Paired t-tests were conducted between pre- and post-assessments scores to test that both training programs were effective.

Additionally, a mixed effects generalized linear model estimated the effect of the training program on scores, adjusted for patient baseline score, time and training condition.

Surveys

A within-subjects design was employed: each participant received both types of training. Items assessing confidence, skill, and knowledge were averaged for the pre-assessment and post- assessment administrations. Descriptive statistics were calculated for all measures.

Participants were asked to complete pre- and post-assessments to evaluate their level of comfort in the procedure and overall satisfaction whilst using these task trainers. The questionnaire (Figure 4) contains these two sections, each built to assess one or the other.

The first section asks participants to disclose their level of agreeance/agreement with the following statements: I feel confident in performing the procedure in my practice; My skill in performing the procedure is adequate; My knowledge of the procedure is adequate. The section asks participants to disclose their level of agreeance/agreement with the following statements: The instructor was knowledgeable about the procedure; The task trainer was realistic; The task trainer was easy to use; I had sufficient time to practice with the task trainer; The necessary equipment and tools for the indicated procedure were provided; I would recommend using this task trainer to a colleague or coworker.

Finally, participants are provided the opportunity to offer comments, feedback, and thoughts of prospective trainers that they would like to see offered.

Production Components

The Mirro Internal Jugular Line Trainer (Figure 3) provides an alternative option to live model practice by providing a system which replicates all the characteristics of a live model. Real tissue characteristics, laminar venous, and pulsatile carotid flow are recreated thus providing a realistic training environment. This novel task trainer was produced using the resources itemized in “Bill of Material” (Table 1).

The neck is the main component of the IJ trainer. It is composed of 10% ballistic gel that has carbon powder incorporated to provide opacity and realistic ultrasound granularity. There are two pairs of silicon tubing. One pair representing the right internal jugular vein and right carotid artery is located on the right half of the trainer. Water, used to represent blood, is pumped through the tubing via two separate miniature pumps. A dedicated electronic control system activates one pump to recreate a pulsatile blood flow to the carotid artery. Another pump, directly connected to a USB power bank or equivalent power supply, creates a laminar flow to the internal jugular vein. The other pair of silicone tubing is located on the left half of the neck and provides a cost effect option for prolonging the useful life of the gel neck. When the right pairs of tubing have been damaged due to the multiple needle puncture, the gel neck can be turned 180 degrees and reconnected to provide more practice. The compliance of the gel neck closely approximates human tissue. Similarly, puncturing the “blood vessels” will cause the neck to “bleed” just as it would in a live model.

Under ultrasound imaging, the artificial blood vessels are clearly defined. The carbon powder added to the ballistic gel provides granularity. Without this addition, an unrealistic image with large hypoechoic areas is interrupted only by the pairs of silicone tubing. Turning on the doppler mode, the practitioner is able to observe pulsatile flow in the carotid vessel and laminar flow in the internal jugular vein.

The pump base is a box with raised edges containing a pair of pumps, water reservoir, and tubing. The raised edge of the base allows for water to be recirculated when the gel neck is punctured and “bleeds”. Fluid drains back into the reservoir through two drain holes. One pump located inside the base provides a connection to the carotid tubing and the other pump provides a connection to the internal jugular tubing.

A compact circuit board regulates power to the carotid pump so that an intermittent activation of the pump can simulate carotid blood flow. USB connector designed into the circuit board allows any USB power bank to be used as a power source. Alternatively, a higher-powered power supply such as 6V is used to provide greater flow if one desires.

Production Process

Neck molds are made using aluminum to ensure the durability. Other materials such as silicone can be used which would be capable of withstanding prolonged temperatures of 250 degrees Fahrenheit. However, silicone or high temperature plastics would ultimately degrade under prolonged heat exposure. The mold consists of a semicircular main body and two end plate. The endplates have four holes grouped in two pairs. One pair is positioned at the lower right half and represents the carotid and internal jugular vessels. The other pair is located at the lower left half. The end plates can be replaced with different configurations. A normal anatomy would present the IJ superior and lateral to the carotid artery. Since there are variations to this, the end plate could configure multiple alignments of the vessels for increased challenge.

Molds – necessary materials include: Aluminum Mold
10% Ballistic Gel manufactured by Clear Ballistics 6mm Silicone Tubing
10” Stainless Steel rod 1/8” diameter Oven & Vacuum Chamber

1500g of 10% ballistic Gel is heated in an oven at 250 degrees Fahrenheit until completely melted. 7 grams of carbon powder is added to the gel and thoroughly mixed. 10 inches of silicone tubing is threaded through the corresponding hole in the end plates. Stainless steel rods are inserted through the tube to provide support. Without these rods, the tubing would assume unpredictable positions within the mold. The gel mixture is poured into the mold and placed into the vacuum chamber at -25in H20. After two hours or when the gel has cooled, the mold is reheated until the gel is in liquid state to release any remaining air bubbles. Once the gel has cooled, it is removed from the mold and stored in a container to keep dust from collecting on the surface.

 

Pump Base – necessary materials include: 2x Aluminum bar 4”x5”x0.125” Aluminum channel
2x Aluminum bar 4”x4”x0.25” Aluminum plate 4”x6”x0.08” 2x 5V Water pump model
4 Right angle brass connection ¼” NTP 4 Right angle plastic connectors
6mm Silicone tubing

The aluminum base supporting the gel is a water reservoir which also houses two internal water pumps. These pumps deliver pulsatile and steady flow through two tubing that connect to the neck gel. As the gel is punctured during the procedure, water will inevitably leak. Since there is a raised barrier around the gel, water will not flow onto the table. Instead, water will drain back into the pump base via holes drilled at one end (Figures 1 & 2).

The electronic pump control is designed to control the water pump located within the base. There are two settings: pulsatile and non-pulsatile.

Table 1: Itemized, tabulated list of materials necessary for production.

Neck Gel

Part

Per unit [USD]

Ballistic Gel 411g per unit

3.61

silicone tubing

0.40

silicone tubing

0.40

silicone tubing

0.40

silicone tubing

0.40

total

5.21

 

Pump Base

Part

Per unit [USD]

Aluminum Rectangle Tube 6063-T52-Extruded 1.5"x2.5"x0.125"

 

10.69

Aluminum Rectangle Bar 6061-T6511 Extruded

7.81

0.25"x2.5" Aluminum Rectangle Bar 6061-T6511 Extruded

3.90

0.25"x2.5" Aluminum Rectangle Bar 6061-T6511 Extruded

3.90

top plate

10.00

Hex coupling 1/4x1/4 NTP

5.00

1/4 NTP Elbow

12.29

total

53.59

 

Pump Control Circuit

Part Number

Description

Per unit [USD]

Per 100 units [USD]

 

Printed Circuit board

0.68

0.40

KUSBX-SMT2AP5S-B

USB Connectors A TYPE SMT BLK PLUG 1.35mm POSTS

SHIELD male Surface Mount

1.10

0.754

87583-2010BLF

USB Connectors 4P RECEPTACLE TYPE A Female surface mount

1.00

0.689

AP7370-33SA-7

3.3V SMT Volt Reg

0.52

0.281

2SS100L-W

Schottky Diodes & Rectifiers 100V 2A SM SCHOTTKY Barrier

Rectifier

0.11

0.088

2SS100L-W

Schottky Diodes & Rectifiers 100V 2A SM SCHOTTKY Barrier

Rectifier

0.11

0.088

LBC3225T330KR

Fixed Inductors 1210 33uH 533mOhms +/-10% 500mA

0.15

0.087

CRCW0603150RFKEAC

Thick Film Resistors - SMD 1/10Watt 150ohms 1%

0.10

0.010

CL31A107MQHNNWE

Multilayer Ceramic Capacitors MLCC - SMD/SMT 100uF+/-

20% 6.3V X5R 3216 Case 1206

0.49

0.209

CL31A107MQHNNWE

Multilayer Ceramic Capacitors MLCC - SMD/SMT 100uF+/- 20% 6.3V X5R 3216 Case 1206

0.49

0.209

 

PIC10F322T-E/OT

8-bit Microcontrollers - MCU 896 B Flash, 64 B RAM, 4 I/O, 8bit ADC, PWM, CLC, NCO, CWG, TEMP Indicator, 2.3V -

5.5V

 

0.66

 

0.536

SI2312BDS-T1-E3

MOSFET N-Channel 20V 3.9A

0.43

0.255

SK14D01G6

Slide Switch SP4T

0.43

0.350

CL21A106KOQNNNG

10uF MLCC capacitor

0.10

0.034

 

total

6.37

3.606

 

 

Total production cost of novel trainer consisting of neck gel, pump base, pump control circuit:

$65.17 USD (single unit) or $62.41 USD (100 units)
*Production cost is slightly decreased when produced in large volumes due to bulk material purchase.

Total purchase cost of commercial trainer [CAE Blue Phantom Ultrasound Central Line Trainer]:

$2,915.00 USD (single unit)

 

Figure 1: Front-side, transparent graphic of novel task trainer displaying internal components and respective measurements.

 

Figure 2: Left-side, transparent graphic of novel task trainer displaying internal components and respective measurements.

 

Figure 3: Finalized concept model of novel task trainer.1

 

Figure 4: Pre- and post-assessment.

 

Results

The improvement in scores for the AMSL training group was 1.46 (SD=0.87) and improvement for the commercial training group was 1.46 (SD=1.07). With the improvement scores for both types of training nearly identical, the hypothesis test of difference in score improvement was non-significant. The t-test for the difference in changes was t(15)=0, p>.99. The 95% confidence interval for estimated change due to either training was [0.94, 1.98]. The difference between pre- assessment and post-assessment mean scores for confidence, skill, knowledge for each training program was significant (Figure 5).

The estimated change in scores and 95% confidence intervals for each training program were calculated. Participants reported equivalent improvement in confidence, skill, and knowledge related to central venous catheter insertion using both the commercial and novel central venous catheter insertion simulation task trainers.

Figure 5: Tabulated statistical analysis of pre- and post-assessments.

Discussion

This study reiterated the need for a task trainer of sufficient caliber to imitate currently available task trainers at a low cost. Participants in this study demonstrated improved knowledge and comfort scores for both the commercial trainer and the novel trainer, suggesting the efficacy of the novel trainer, as designed, is at least satisfactory in replacement of the commercial trainer.

These improvements from the pre-assessment to the post-assessment also suggest that, while utilization of both trainers lead to favorable – and similar – results, the money-saving novel trainer is clearly a beneficial alternative.

The favorable results of the survey analysis advocate for the production and implementation of similar projects moving forward. Participants in any future instructional sessions will have the opportunity to utilize and learn from a device that is adequate and, due to cost savings, more readily available. Internal production and implementation of this specific device will continue, and the hope is that this study will promote the adoption of this idea to external simulation centers as a means for non-inferior product realization and overall budget regulation and conservation.

While benefits of this novel simulation task trainer are promising, the study had several limitations. The sample size for this study was less than anticipated at n=15. This sample size is considered a limitation as its magnitude will not sufficiently represent the general population. This highlights a need for future research on similar, devices with a primary purpose of cost- saving. In future studies, conducting a longitudinal evaluation could allow for increased magnitude of data, despite the sample size. Additionally, subsequent studies utilizing the same device and surveying tools would allow researchers to, effectively, mimic an extended study of the same basis.

Additionally, employee salary costs to produce the trainer were not included in the bill of material cost. The cost savings discussed may be slightly depreciated by the fact that this internal production requires time and capital investment. This includes the design of the blueprints, gathering of materials, subsequent testing of multiple iterations of the device, the intellectual and human capital from which the idea originates, and, of course, the salaried investment input by the organization. While these may be exclusive to the initial stage of production, future reiterations of the device will require them as well.

Despite limitations to the device and its respective study, this central venous catheter insertion simulation task trainer is a replicable, more economically efficient alternative to a commercial task trainer for simulation-based clinician central venous catheter insertion training. Furthermore, subsequent opportunity for research will provide additional insight into the concept of novel, low-cost task trainers.

References

Jagneaux T, Caffery TS, Musso MW, et al. Simulation-Based Education Enhances Patient Safety Behaviors During Central Venous Catheter Placement. Journal of Patient Safety. 2021;17(6):425-429. doi:10.1097/pts.0000000000000425.

Nitsche JF, Shumard KM, Brost BC. Development and Assessment of a Novel Task Trainer and Targeting Tasks for Ultrasound-guided Invasive Procedures. Acad Radiol. Jun 2017;24(6):700-708. doi:10.1016/j.acra.2016.10.008.

Chen HE, Sonntag CC, Mirkin KA, et al. From the simulation center to the bedside: Validating the efficacy of a dynamic haptic robotic trainer in internal jugular central venous catheter placement. Am J Surg. Feb 2020;219(2):379-384. doi:10.1016/j.amjsurg.2019.10.026.

Golden A, Alaska Y, Levinson AT, et al. Simulation-Based Examination of Arterial Line Insertion Method Reveals Interdisciplinary Practice Differences. Simulation in Healthcare. 2020;15(2):89-97. doi:10.1097/sih.0000000000000428.

Soffler MI, Hayes MM, Smith CC. Central venous catheterization training: current perspectives on the role of simulation. Adv Med Educ Pract. 2018;9:395-403. doi:10.2147/amep.S142605.

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Lau L, Papanagnou D, Smith E, Waters C, Teixeira E, Zhang XC. A novel biosimulation task trainer for the deliberate practice of resuscitative hysterotomy. Advances in Simulation. 2018/10/04 2018;3(1):19. doi:10.1186/s41077-018-0078-1.

Chin CJ, Clark A, Roth K, Fung K. Development of a novel simulation-based task trainer for management of retrobulbar hematoma. International Forum of Allergy & Rhinology. 2020;10(3):412-418. doi:https://doi.org/10.1002/alr.22494.

Lichtenberger JP, Tatum PS, Gada S, Wyn M, Ho VB, Liacouras P. Using 3D Printing (Additive Manufacturing) to Produce Low-Cost Simulation Models for Medical Training. Military Medicine. 2018;183(suppl_1):73-77. doi:10.1093/milmed/usx142.

Park L, Price-Williams S, Jalali A, Pirzada K. Increasing Access to Medical Training With Three-Dimensional Printing: Creation of an Endotracheal Intubation Model. Original Paper. JMIR Med Educ. 2019;5(1):e12626. doi:10.2196/12626.

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