Simulated cardiopulmonary bypass: a high fidelity model for developing and accessing clinical perfusion skills.

BACKGROUND: Traditionally, novice perfusionists learn and practice clinical skills, during live surgical procedures. The profession's accrediting body is directing schools to implement simulated cardiopulmonary bypass (CPB) into the curriculum. Unfortunately, no CPB simulation models have been validated. Here we describe the design and application of a CPB simulation model. METHODS: A CPB patient simulator was integrated into a representative operative theater and interfaced with a simple manikin, a heart-lung machine (HLM), clinical perfusion circuitry, and equipment. Participants completed a simulation scenario designed to represent a typical CPB procedure before completing an exit survey to assess the fidelity and validity of the experience. Questions were scored using a 5-point Likert scale. RESULTS: Participants (n = 81) contributed 953 opinions on 40 questions. The participants reported that the model of simulated CPB (1) realistically presented both the physiologic and technical parameters seen during CPB (n = 347, mean 4.37, SD 0.86), (2) accurately represented the psychological constructs and cognitive mechanisms of the clinical CPB (n = 139, mean 4.24, SD 1.08), (3) requires real clinical skills and reproduces realistic surgical case progression (n = 167, mean 4.38, SD 0.86), and (4) would be effective for teaching, practicing, and assessing the fundamental skills of CPB (n = 300, mean 4.54, SD 0.9). Participants agreed that their performance in the simulation scenario accurately predicted their performance in a real clinical setting (n = 43, mean 4.07, SD 1.03) CONCLUSION: This novel simulation model of CPB reproduces the salient aspects of clinical CPB and may be useful for teaching, practicing, and assessing fundamental skills.

The Effectiveness of Three Different Curricular Models to Teach Fundamental ECMO Specialist Skills to Entry Level Perfusionists.

The dramatic increase in the use of extracorporeal membrane oxygenation (ECMO) over the last decade with the concomitant need for ECMO competent perfusionists has raised questions of how well perfusion education programs are preparing entry-level perfusionists to participate in ECMO. While all perfusion schools teach ECMO principles, there is no standardized or systematic approach to the delivery of didactic knowledge and clinical skills in ECMO. Given this variability of ECMO education across and within perfusion schools, the CES-A exam may provide a metric for comparing curricular approaches. The purpose of this study is to examine three different curricular approaches to prepare new perfusion graduates to master the Adult ECMO Specialist Certification exam (CES-A). We examined three different curricular approaches to prepare new perfusion graduates to master the Adult ECMO Specialist Certification exam (CES-A). We hypothesized that there would be no difference in CES-A pass rate, exam score, Rasch measure, and item category scores between SUNY Cardiovascular Perfusion Program (CVP) graduates who completed SUNY's ECMO Capstone experience (Group III) and CVP graduates who did not select the ECMO Capstone experience (Group II). Further, we studied the performance of a third group of new graduates from an external program that does not offer formal ECMO courses or an ECMO Capstone experience (Group I). Every perfusion graduate in all groups passed the adult ECMO specialist exam. The graduates who as students completed an ECMO Capstone experience (Group III) scored higher on the exam and significantly higher on four exam categories: coagulation and hemostasis (p = .058), lab analysis point of care (p = .035), and monitor patient and circuit (p = .073), and the safety and failure modes (p = .017). Overall the median graduate Rasch measures ranked with Group III demonstrating the highest measure to Group I the lowest measures (not significant at p = .085). There is a positive educational effect due to CVP graduates completion of the ECMO Capstone experience compared to the program standard ECMO-related curricula in the two perfusion programs participating in this study. From this observation a structured ECMO simulation-based program appears to be equally effective as a traditional, typical lecture-only, clinical perfusion preceptorship, while demonstrating a more satisfactory experience with a higher reported case experience. In this study the standard perfusionist education curriculum prepared the new graduate to be successful on the CES-A exam. The three curricular approaches appear to prepare perfusionist graduates to be successful on the Adult ECMO Specialist exam.

Objective Content Validation of the Hemodynamic and Technical Parameters of the OrpheusTM Cardiopulmonary Bypass Simulator.

The utilization of simulators for training is increasing in the professions associated with cardiac surgery. Before applying these simulators to high-stakes assessment, the simulator's output data must be validated. The aim of this study is to validate a Cardiopulmonary Bypass (CPB) simulator by comparing the simulated hemodynamic and technical outputs to published clinical norms. Three Orpheus™ CPB simulators were studied and compared to a published reference of physiologic and technical metrics that are managed during clinical CPB procedures. The limits of the simulators user modifiable variables were interrogated across their full range and the results were plotted against the published clinical norms. The data generated with the simulator conforms to validated clinical parameters for patients between 50 and 110 kg. For the pre- and post-CPB periods, the independent variables of central venous pressure (CVP), heart rate (HR), contractility, and systemic vascular resistance (SVR) must be operated between the limits of 7 and 12 mmHg, 65 and 110 beats/min, 28% and 65%, and 6 and 32 units respectively. During full CPB the arterial pump flows should be maintained between 3.5 and 5.5 LPM and SVR between 18 and 38 units. Validated technical parameters during cardioplegia delivery are expected at solution flow rates between 250 and 400 mL/min and 100 and 225 mL/min for antegrade and retrograde delivery routes, respectively. We have identified the limits for user-modifiable settings that produce data conforming to the physiologic and technical parameter limits reported in the peer reviewed literature. These results can inform the development of simulation scenarios used for high stakes assessments of personnel, equipment, and technical protocols.

Survey of the Routine Practice Limits for Physiologic and Technical Parameters Managed by Clinical Perfusionists during Adult Cardiopulmonary Bypass.

Cardiopulmonary bypass (CPB) is a highly technical clinical discipline with a recognized variability in practice. Professional standards and guidelines documents help direct clinical practice and reduce variability, but these guidelines are necessarily vague and fall short of providing specific objective recommendations of clinical practice metrics. If clinical practice metrics were known, they would be informative when writing departmental policy manuals, structuring quality improvement initiatives, describing product R&D specifications, and designing educational assessment rubrics. Therefore, to address this gap, we conducted a national survey of clinical practice with the purpose of producing a benchmark of the typical variability of specific technical parameters that are commonly managed during adult CPB procedures. A pool of expert clinical perfusionists collaborated to compile a data set of normal ranges for 41 individual physiologic and technical parameters (pressures, flows, saturation, times, solutions, and temperatures) that are commonly managed during adult CPB procedures. Results were collected using an online survey application. Respondent demographics and measures of central tendency with descriptive quartile statistics and confidence intervals for each parameter are presented. Of the 335 people who participated in the survey, 315 met the inclusion criteria. The geographic demographics of the respondents were representative of the American Board of Cardiovascular Perfusion's distribution of certified clinical perfusionists. Of the 41 parameters investigated, there were 13 hemodynamic parameters, 13 normal flow rates and technical circuit parameters, 10 blood gasses and hematocrit parameters, and five parameters of patient temperatures. The data presented here are informative and provide a consensus-based objective assessment of the standard practice for adult CPB as reported by practicing clinical perfusionists. Based on these survey data, we have identified the typical clinical limits for the 41 parameters that are managed during adult CPB. This information may be incorporated into guiding documents to support the work of clinicians, researchers, and educators.

Development of the Adult ECMO Specialist Certification Examination.

The American Society of Extracorporeal Technology Board of Directors, consistent with the American Society of Extracorporeal Technology's safe patient care improvement mission, charged the International Board of Blood Management to write a knowledge and skill certification examination for healthcare personnel employed as adult extracorporeal membrane oxygenation (ECMO) specialists. Nineteen nationally recognized ECMO subject-matter experts were selected to complete the examination development. A job analysis was performed, yielding a job description and examination plan focused on 16 job categories. Multiple-choice test items were created and validated. Qualified ECMO specialists were identified to complete a pilot examination and both pre- and post-examination surveys. The examination item difficulty and candidate performance were ranked and matched using Rasch methodology. Candidates' examination scores were compared with their profession, training, and experience as ECMO specialists. The 120-item pilot examination form ranked 76 ECMO specialist candidates consistent with their licensure, ECMO training, and clinical experience. Forty-three registered nurses, 28 registered respiratory therapists, four certified clinical perfusionists, and one physician assistant completed the pilot examination process. Rasch statistics revealed examination reliability coefficients of .83 for candidates and .88 for test items. Candidates ranked the appropriateness for examination items consistent with the item content, difficulty, and their personal examination score. The pilot examination pass rate was 80%. The completed examination product scheduled for enrollment in March 2020 includes 100 verified test items with an expected pass rate of 84% at a cut score of 67%. The online certification examination based on a verified job analysis provides an extramural assessment that ranks minimally prepared ECMO specialists' knowledge, skills, and abilities (KSA) consistent with safe ECMO patient care and circuit management. It is anticipated that ECMO facilities and ECMO service providers will incorporate the certification examination as part of their process improvement, safety, and quality assurance plans.

Staffing, Equipment, Monitoring Considerations for Extracorporeal Membrane Oxygenation.

Although the reasons for the recent growth in adult extracorporeal membrane oxygenation (ECMO) are multifactorial, much of the success may be attributed to the development of well-trained staff and the technological innovations in equipment and monitoring devices used during extracorporeal support. In this article, the authors discuss general educational formats for the ECMO bedside provider, staffing support models, and devices designed to best meet the needs of the patient while simultaneously ensuring the proper delivery of ECMO-related care.

Vacuum-Assisted Venous Drainage: A 2014 Safety Survey.

Despite the widespread use of vacuum-assisted venous drainage (VAVD) and case reports describing catastrophic incidents related to VAVD, there is a lack of data cataloging specific safety measures that individuals and institutions have incorporated into their VAVD practices for the prevention of these incidents. Therefore, the purpose of this study is to survey the perfusion community to gather data on VAVD practices, and to compare these current practices with literature recommendations and the American Society of ExtraCorporeal Technology (AmSECT) Standards and Guidelines. In September 2014, a survey was distributed via PerfList and PerfMail, and by direct e-mail to members of the New York State Society of Perfusionists, targeting certified clinical perfusionists in New York State. Survey topics pertaining to VAVD practice included 1) equipment, 2) pressure monitoring and alarms, 3) protocols, checklists, and documentation, and 4) VAVD-related incidents. Of ∼200 certified clinical perfusionists who live and/or work in New York State (NYS), 88 responded (42%). Most respondents (90.1%) report they use VAVD. Of these, 87.3% report that they monitor VAVD pressure, with 51.6% having audible and visual alarms for both positive and excessive negative pressures. At the institutional level, 61.2% of respondents reported that there is a protocol in place at for their team limiting negative pressure in the reservoir, 28.4% document VAVD pressure in the pump record, and AmSECT's three recommended VAVD checklist items are met with 53.7%, 55.1%, and 33.8% compliance. In conclusion, the results of this study reveal that the use of VAVD has increased and has become nearly universal in 2014. There is high compliance to some of the literature recommendations and AmSECT Standards and Guidelines, however, there are still some gaps between current practices and these recommendations. Continued improvement, both at the individual and institutional levels, will help to improve patient safety by preventing untoward events from occurring while using VAVD.

The potential of accurate SvO2 monitoring during venovenous extracorporeal membrane oxygenation: an in vitro model using ultrasound dilution.

INTRODUCTION: Some degree of recirculation occurs during venovenous extracorporeal membrane oxygenation (VV ECMO) which, (1) reduces oxygen (O2) delivery, and (2) renders venous line oxygen saturation monitoring unreliable as an index of perfusion adequacy. Ultrasound dilution allows clinicians to rapidly monitor and quantify the percent of recirculation that is occurring during VV ECMO. The purpose of this paper is to test whether accurate patient mixed venous oxygen saturation (SvO2) can be calculated once recirculation is determined. It is hypothesized that it is possible to derive patient mixed venous saturations by integrating recirculation data with the ECMO circuit arterial and venous line oxygen saturation data. METHODS: A test system containing sheep blood adjusted to three venous saturations (low-30%, med-60%, high-80%) was interfaced via a mixing chamber with a standard VV ECMO circuit. Recirculation, arterial line and venous line oxygen saturations were measured and entered into a derived equation to calculate the mixed venous saturation. The resulting value was compared to the actual mixed venous saturation. RESULTS: Recirculation was held constant at 30.5 +/- 2.0% for all tests. A linear regression comparison of "actual" versus "calculated" mixed venous saturations produced a correlation coefficient of R2 = 0.88. Direct comparison of actual versus calculated saturations for all three test groups respectively are as follows; Low: 31.8 +/- 3.95% vs. 37.0 +/- 6.7% (NS), Med: 61.7 +/- 1.5% vs. 72.3 +/- 1.8% (p < 0.05), High: 84.4 +/- 0.9% vs. 91.2 +/- 1.1% (p < 0.05). DISCUSSION: There was a strong correlation between actual and calculated mixed venous saturations; however, significant differences between actual and calculated values where observed at the Med and High groups. While this data suggests that using quantified recirculation data to calculate SvO2 is promising, it appears that a straightforward derivative of the oxygen saturation-based equation may not be sufficient to produce clinically accurate calculations of actual mixed venous saturations.

Use of dilutional ultrasound monitoring to detect changes in recirculation during venovenous extracorporeal membrane oxygenation in swine.

Since recirculation during venovenous extracorporeal membrane oxygenation (VV ECMO) reduces oxygen delivery to the patient, monitoring recirculation is necessary to guide clinicians in interventions that may reduce recirculation and thereby optimize patient care. The use of dilutional ultrasound may be a clinically practical way to quantify recirculation during VV ECMO. This study evaluates in a swine model of VV ECMO a dilutional ultrasound techniques ability to provide accurate recirculation data under changing conditions. One 16-kg swine was cannulated with a dual-lumen cannula and placed on VV ECMO. Recirculation measured by using blood oxygen saturations (r = S(preox) - SVO2/S(postox) - SVO2) was compared with recirculation measured by a saline dilution ultrasound technique. Dilutional ultrasound was then used to measure changes in baseline recirculation in the face of (a) cannula repositioning and (b) a drug-induced cardiac output change. The comparison of recirculation calculations between the saturation method and dilutional ultrasound were similar at all flow rates measured. The time for results was much faster with the use of dilutional ultrasound. Induction of recirculation changes by repositioning the cannula or changing cardiac output was rapidly detected using dilutional ultrasound and showed significant differences from baseline recirculation. Dilutional ultrasound provides a clinically practical method to quantify and monitor recirculation in VV ECMO applications and may aid in assessing interventions to improve oxygen delivery.

Internet-based virtual classroom and educational management software enhance students' didactic and clinical experiences in perfusion education programs.

A challenge faced by many university-based perfusion education (PE) programs is the need for student clinical rotations at hospital locations that are geographically disparate from the main educational campus. The problem has been addressed through the employment of distance-learning environments. The purpose of this educational study is to evaluate the effectiveness of this teaching model as it is applied to PE. Web-based virtual classroom (VC) environments and educational management system (EMS) software were implemented independently and as adjuncts to live, interactive Internet-based audio/video transmission from classroom to classroom in multiple university-based PE programs. These Internet environments have been used in a variety of ways including: 1) forum for communication between the university faculty, students, and preceptors at clinical sites, 2) didactic lectures from expert clinicians to students assigned to distant clinical sites, 3) small group problem-based-learning modules designed to enhance students analytical skills, and 4) conversion of traditional face-to-face lectures to asynchronous learning modules. Hypotheses and measures of student and faculty satisfaction, clinical experience, and learning outcomes are proposed, and some early student feedback was collected. For curricula that emphasize both didactic and clinical education, the use of Internet-based VC and EMS software provides significant advancements over traditional models. Recognized advantages include: 1) improved communications between the college faculty and the students and clinical preceptors, 2) enhanced access to a national network of clinical experts in specialized techniques, 3) expanded opportunity for student distant clinical rotations with continued didactic course work, and 4) improved continuity and consistency of clinical experiences between students through implementation of asynchronous learning modules. Students recognize the learning efficiency of on-line information presentation but still prefer the traditional face-to-face classroom environment. Traditional paradigms impose limitations that are rooted in dependence upon the students and instructors being physically located in the same place at the same time. These represents significant impediments for PE programs that use geographically separate clinical sites to provide clinical experience. Historically this has led to a disintegration of the presentation of theory, and a reduction in the quantity or quality of clinical experience opportunities. New PE models help to eliminate limitations and improve the quality of education especially in the face of economic challenges. Perfusion education students and faculty will have to work together to find computer-based offerings that are equivalent to traditional classroom methods.