Tentative title: ECMO In The age of COVID and Why We Need an Interdisciplinary Approach to Mitigating Ethical Dilemmas

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Tentative title: ECMO In The age of COVID and Why We Need an Interdisciplinary Approach to Mitigating Ethical Dilemmas. • Concise statement of manuscript's purpose: o At the fore front of COVID treatment in the critically ill, it remains a major source for ethical dilemma amongst critical care nurses. This manuscript will focus on multiple ethical battles engaged in delivering high cost, high technology driven critical care and their impact on the nursing profession. • • Intended audience (who you will be writing to): o physicians and critical care nurses, clergy, ethics committees. o As the Corona virus continue to lay waist across our lands disproportionately Intro: affecting the disenfranchised we have found hope in the modern technology and in those whom wield their power. With advances in healthcare also come uncharted ethical dilemmas such as unilateral approaches to saving lives, implantation of cost reductions to make it more affordable/profitable, and burnout and stress amongst healthcare providers. 1. Ethical dilemma #1: a. unilateral approaches to saving lives)→ ECMO is pushed a liable option however the survival rate may remain low with futile outcome. b. Physicians overselling ECMO → more experience under their belt/to be ECMO center c. Limited ECMO machines, who gets to decide who gets cannulated for ECMO? 2. Ethical Dilemma #2: Ethic and palliative care evolvement in ECMO discussions and goals of care. i. How should the initiation and withdrawal decision be made? 1. How long should they stay on ECMO? 2. Indications for withdrawing 3. Should we include do not ecmo in advance directive? And consider it a new code status? 3. Ethical dilemma #3: a. Ethical dilemma regarding sufficient ECMO RN training comparing to perfusionists: In one local hospital, 3 days of didactic and 4 bedside orientation shifts allows the most mediocre RN to be considered a proficient ECMO specialist. Although highly skilled, nurses lack the foundational education and clinical hours to master the complexities of ECMO in a dying patient. In other hospitals, the RNs may stabilize the patient until out of the house perfusionist arrives, but the instate that that patient is getting a highly skilled and highly educated provider whose sole focus is on one patient. When you assume the risk of adding more ECMO nurses to reduce the cost of having more perfusionist, you unfortunately diminish the care for these patients at the most critical time. b. Criteria to be ECMO nurse? How many years of experience and how is it decided who becomes an ECMO nurse? 4. Ethical Dilemma #3: a. ECMO RN- patient ratio: No specific protocol in place. At a local hospital, the nurse run ECMO program started in 2018 with a 2:1 ratio (1 ECMO nurse and one primary nurse for 1 patient). Due to ECMO nurse shortage and nurses’ shortage, the required ECMO: patient ratio changed to 1:1. In the recent months and with increase COVID patients needing for ECMO, increase burnout amongst ICU nurses, the leadership team are implementing a new requirement of 1 ECMO nurse overseeing 3 patients. We have begun to take the junior ICU primary nurses and expanding their duties to take responsibility of managing some of the ECMO operations based off of a two hour “Primary ECMO RN Education” didactic course. 5. Burnout and moral distress of ECMO RN: a. With the increase responsibility, no incentive, increase workload and minimal training, the intensive care unit is facing a great moral distress amongst nurses. Personal incentive for the RN responsibility rises but compensation remains stagnate. No incentive to excel at this other than moral to do more. 6. Recommendations: a. Need additional studies for safe ECMO to patient ratio, goal of care discussion and involvement of palliative care and ethics committee. Setting realistic goals and plan of care with caregivers. 7. Conclusion: 8. Reference List: ** This is a newer topic and I was unable to find many lit articles regarding ECMO:patient ratio. If you guys have any ideas, recommendations, or have witnessed other dilemmas in ECMO centers, I’ll appreciate the insight. Literature Identification Worksheet Title: ECMO In The age of COVID and Why We Need an Interdisciplinary Approach to Mitigating Ethical Dilemmas. • manuscript's purpose: o At the fore front of COVID treatment in the critically ill, it remains a major source for ethical dilemma amongst critical care nurses. This manuscript will focus on multiple ethical battles engaged in delivering high cost, high technology driven critical care and their impact on the nursing profession. o Ethical Dilemmas covered: ECMO goals of care decision, withdrawal of care for ECMO patients, how long do they remain on ECMO? who decides it? Underutilization of palliative care and ethic committee, and safe RN ECMO specialists staffing ratios. Reference ELSO Guidelines Type of article (e.g., research, clinical guidelines, case study, quality rating) Clinical Guidelines Methods (Who? What? Where? How? Key findings or info that would be [especially note sample and research important to present in my manuscript design, and nature of intervention if it is relevant to you]) 1- Use to cite and explanation the - ELSO is Extracorporeal Life current process to train ECMO nurse Support Organization: It specialists continuing education provides support to institutions classes. delivering extracorporeal life 2- Use to site the ELSO support through continuing recommendation for stopping education, guidelines ECMO for futility. development, original research, publications and maintenance of a comprehensive registry of patient data. Shekar et al. 2020 Clinical guidelines - A document that presents recommendations that have been put together by a team of interdisciplinary ECMO providers from around the world. Recommendations are based on available evidence, existing best practice guidelines, ethical principles, and expert opinion 1- Recommends maintain a 1:1 patient nurse ratio when on ECMO. 2:1 when capacity is at contingency Tier 2 and crises levels. 2- Redeployment of perfusionist to bedside ECMO (not having primary RN learn basic ECMO skills in a two-hour class!) 3- Indication and contraindication for ECMO in adult COVID.. are hospitals following the guidelines and not cannulating people >65 years old? No! 4- Consent should explicitly involve discontinuation of ECMO care in the absence of recovery of lungs, heart or both WITHIN AN ACCEPTABLE TIME FRAME 5- Ethical issues “Patient selection and timing of discontinuation of ECMO support pose significant ethical and moral challenges in regular ECMO care, but especially so during a pandemic. ECMO centers should develop predetermined “consensus criteria” encompassing all aspects of ECMO care in COVID-19 patients” 6- Recommendation for ethics and palliative care team before cannulation and throughout the ECMO course. Lucchini et al., 2019 Research/Observational Study - Retrospective observational study. Data from nursing activity score (NAS) were collected for seventy-two - Use to support staffing issues: “Our findings suggest that in ECMO patients a nurse-to-patient ratio equal to 1:1, should be guaranteed in accordance to the - - consecutive months from January 2010. Total of 2606 patients enrolled. ECMO patients enrolled 95 (4%) with 3141 ECMO days. ECMO patients NAS median = 87.0 Non ECMO pts median NAS = 67.2 national health regulations and organizations.” Note: pronig pts, hourly I/Os, number of sedatives/paralytics/vasopressors/assessment of ECMO sites/bleeding risks/assessment all affect workload. *study approved by ethics committee *used NAS tool to measure workload and SPSS to analyze the data **Limitation: “This is a retrospective single-centre study. Conclusions may have some bias related to the individual centre.” Alshammari, M., Vellolikalam, C., and Alfeeli, A., (2020) Abrams et al., 2019 Research/ qualitative - International survey scenario-based survey. Qualitative descriptive approach Interviewed 19 nurses working in Kuwait. **Critique: very small sample size and location of study. - Electronic, cross-sectional, scenario-based survey. - Nurses reported encountering significant challenges including heavy workload. And better interdisciplinary communication. - Only 29.5% involved bedside nurses in treatment decisions for ECMO - 539 physicians in 39 countries completed the survey. This study is the first to characterize the ethical attitudes and opinions of 539 physicians across 39 countries and six conti- nents who have experience managing adult patients receiving venovenous ECMO. - - - Less than 30% always or very often involve nurses in ECMO decision making/withdrawals. Only half of all respondents agreed that ethics consultation is important when making difficult decisions regarding withdrawal of lifesustaining therapies, Only two-thirds of respondents reported that they very often or always discuss the possibility of ECMO with- drawal in case of futility with the patient or surrogate Gannon et al., 2020 Research - - To evaluate a critical care nurse ECMO cur- riculum that may be reproducible across institutions. 301 ICU nurses new to ECMO Limitation to ECMO teaching curriculum in their study: “Our study has some limitations. The curriculum was the only means of teaching that we measured, limiting the ability to compare the effect of this teach- ing method with others. When comparing written knowledge examination scores between groups, we did not adjust for any potential confounders, such as personal history of ECMO experience outside our institution, duration of nursing experience, or duration of ICU experience. We examined no patient or clinical measures. Therefore, we are unable to demonstrate whether this curriculum has any association with improved quality of patient care or clinical out- comes. Finally, pre course and post course examination questions were the same and were not validated” Courtwright et al., 2016 Research/retrospective, descriptive study - - retrospective, descriptive cohort study of all ECMO ethics consultation cases in the CSICU at a large academic hospital between 2013 and 2015. 113 pts placed on ECMO. - - - 113 pts placed on ECMO. 45 seen by the ethics committee initial consultation occurred two days after initiating ECMO. The most common ethical issue involved disagreement about the ongoing use of ECMO, which included multiple axes: Disagreement among health care providers, disagreement among surrogates, and disagreement between health care providers and surrogates over stopping or continuing ECMO “ECMO was typically initiated in a time-sensitive manner, leaving little room for a sustained conversation about “stopping conditions” or acceptable duration of a time-limited trial from the patient’s perspective. Early clarification, however, about acceptable functional outcomes following ECMO may be helpful in contextualizing later changes in the patient’s clinical trajectory” the majority of consults came from a member of the nursing staff. As other authors have suggested, however, the burdens of providing interventions believed to be - nonbeneficial fall more heavily on “bedside” health professionals such as nurses” In cases in which clinicians and ethics consultants recommended withdrawing ECMO despite surrogate demands, the consultants were able to rely on a broader institutional policy about limiting or not offering nonbeneficial treatment despite surrogate requests (13). Although the policy was not formally invoked in any case, ethics consultants noted the availability of the policy in several cases if consensus could not be reached. Having a policy for clinicianguided limitation of life-sustaining treatment in combination with setting clear expectations may have helped avoid cases of intractable conflict as some authors have described” Abrams et al., 2014 Ethical Dilemmas Encountered With the Use of Extracorporeal Membrane Case studies Describing different cases and the ethical dilemma in each case -DNR with ECMO order? Do not ECMO? - Awake pt on ECMO with no chance of recovery. “bridge to nowhere” - What If pt is awake and refuses to stop ECMO? Oxygenation in Adults Daly, K. & Camporota, L. & Barrett, N. (2016) Cross sectional study - Cross sectional international survey Electronic questionnaire sent to 177 worldwide centers with 82% response rate. Aim was to identify ECMO staffing arrangements - Centers using 1:1 staffing ratio. 65% uses 1:1 nurse:pt ratio, 14% used 1:2 ratio. 6% used 1:3 ratio and 1% used 1:4 ratio. ELSO GUIDELINES FOR TRAINING AND CONTINUING EDUCATION OF ECMO SPECIALISTS PURPOSE The "ELSO Guidelines for Training and Continuing Education of ECMO Specialists" is a document developed by the Extracorporeal Life Support Organization (ELSO) as a reference for current and future ECMO centers. It is to be used as a guideline for designing training and education programs for ECMO specialists. It is assumed that each ECMO center must develop their institution specific guidelines and policies for training ECMO Specialists, which may vary. In the development of these documents and programs, ECMO Directors and Coordinators must take into account their institution's requirements for in-house training programs, and must have policies and procedures reviewed by appropriate hospital committees. Please note that institutional and personnel requirements for ECMO programs are addressed in the ELSO document, "Guidelines for ECMO Centers", and will not be discussed in this document. ELSO Guidelines for Training and Continuing Education of ECMO Specialists Version 1.5 February 2010 Page 1 INTRODUCTION The term "ECMO Specialist" is defined for the purpose of these guidelines as "the technical specialist trained to manage the ECMO system and the clinical needs of the patient on ECMO under the direction and supervision of a licensed ECMO trained physician. The individual functioning as the ECMO Specialist should have a strong critical care background in neonatal, pediatric and/or adult critical care and have attained one of the following: 1. Successful completion of an approved school of nursing and achievement of a passing score on the state written exam given by the Board of Nursing for that state; 2. Successful completion of an accredited school of respiratory therapy and have successfully completed the registry examination for advanced level practitioners and be recognized as a Registered Respiratory Therapist (RRT) by the National Board of Respiratory Care (NBRC). 3. Successful completion of an accredited school of perfusion and national certification through the American Board of Cardiovascular Perfusion (ABCP). 4. Physicians trained in ECMO who have successfully completed institutional training requirements for the clinical specialists. 5. Other medical personnel such as biomedical engineers or technicians who received specific ECMO training and have practiced as an ECMO specialist since the initiation of their programs, and who have completed equivalent training in ECMO management as the other specialists, have successfully documented necessary skills as an ECMO specialist, and who have been approved specifically as an ECMO specialist by the medical director. These personnel can be approved institutionally as an ECMO specialist under the “grandfather” principle. However ELSO does not encourage or support the new training of individuals except as outlined in 1-4 above. TRAINING Training of the ECMO will be divided into two parts. Training for new ECMO programs (centers which have not treated patients) will be covered separately from training for experienced ECMO programs (centers which have been in ongoing operation and are training new ECMO specialists). ELSO Guidelines for Training and Continuing Education of ECMO Specialists Version 1.5 February 2010 Page 2 TRAINING OUTLINE: NEW ECMO PROGRAM A. Didactic Course: The didactic course should include, but not be limited to the following topics. Between 24 to 36 hours will be required to cover the following material. Case presentations are encouraged. Topics could include, but are not limited to the following: Introduction to ECMO: History Current status Indications Risks and benefits Membrane gas exchange physics and physiology Oxygen content, delivery and consumption Shunt physiology Types of ECMO Future applications Research Physiology of the diseases treated with ECMO: Persistent Pulmonary Hypertension Meconium Aspiration Syndrome Respiratory Distress Syndrome Congenital Diaphragmatic Hernia Sepsis/pneumonia Post-operative congenital heart disease/heart transplantation Cardiomyopathy/myocarditis ARDS Aspiration pneumonia Pulmonary embolism Pre ECMO Procedures: Notification of the ECMO Team Cannulation procedure -open -percutaneous Initiation of bypass Responsibility of team members Criteria and contraindications for ECMO including: Patient Selection Selection criteria Pre-ECMO evaluation ELSO Guidelines for Training and Continuing Education of ECMO Specialists Version 1.5 February 2010 Page 3 Physiology of coagulation including: Coagulation cascade Activated clotting times (ACT's) Disseminated intravascular coagulation Blood products and interactions Blood product management of the bleeding patient Blood surface interactions Laboratory tests Heparin pharmacology Use of Amicar, Protamine and other drugs ECMO equipment including: Circuit priming Oxygenator function and blood gas control ECMO circuit design ECMO circuit components (cannula, pump, venous return monitor, in-line saturation monitor, pressure monitor, heater, hemofilter, bubble detector) Physiology of Venoarterial and Venovenous ECMO: Indications Physiology Advantages/disadvantages Daily Patient and Circuit management on ECMO including: Patient: Fluid, electrolytes and nutrition Respiratory Neurologic Infection control Sedation and pain control Hematology Cardiac Psychosocial Circuit: Aseptic technique Pump/gas flow Pressure monitoring Blood product infusion techniques Circuit infusions Management of anticoagulation Circuit checks Hemofiltrations set-up Bedside care of the ECMO patient ELSO Guidelines for Training and Continuing Education of ECMO Specialists Version 1.5 February 2010 Page 4 Emergencies and complications during ECMO: Medical: Intracranial and other hemorrhage Pneumothorax/pneumopericardium Cardiac Arrest Hypotension/hypovolemia Severe coagulopathy Seizures Hemothorax/hemopericardium Uncontrolled bleeding Mechanical: Circuit disruption Raceway rupture System or component alarm/failure (pump, bladder, venous return monitor, oxygenator, heater) Air embolus Inadvertent decannulation Clots Management of complex ECMO cases: Surgery on ECMO -post-operative bleeding Transport on ECMO (inter and intra-hospital) Weaning from ECMO (techniques and complications): Clinical indications of pulmonary/cardiac recovery Pump/gas flow weaning techniques ACT changes during weaning Ventilatory changes during weaning Trial off/decannulation from low flow Decannulation procedures: Personnel needed Medications required Potential complications Vessel ligation Vessel reconstruction Percutaneous approach Post ECMO complications: Platelet and electrolyte alterations ELSO Guidelines for Training and Continuing Education of ECMO Specialists Version 1.5 February 2010 Page 5 Short and long-term developmental outcome of ECMO patients: Institutional follow-up protocol Literature review Ethical and social issues: Consent process Parental and family support Withdrawal of ECMO support B. Water-drills: These sessions should be small enough so that each individual has hands-on experience. A full understanding of all possible circuit emergencies and the appropriate intervention should be accomplished by the end of this session.