COVID-19 Management Protocols: Mount Sinai Health Systems
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Practical Protocols for Managing Patients With SARS-CoV-2 Infection (COVID-19) in the Emergency Department

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Evan S. Leibner, MD, PhD1 2 3 4
Sonya Stokes, MD, MPH 2 5
Danish Ahmad, MD1 2 3 4
Eric Legome, MD 2 5
  1. Institute for Critical Care Medicine, Icahn School of Medicine at Mount Sinai, New York, NY
  2. Department of Emergency Medicine, Icahn School of Medicine at Mount Sinai, New York, NY
  3. Department of Medical Education, Icahn School of Medicine at Mount Sinai, New York, NY
  4. Mount Sinai Hospital, New York, NY
  5. Mount Sinai West and Mount Sinai Morningside Hospitals, New York, NY
Corresponding Author:
Evan Leibner, MD PhD
One Gustave Levy Place, Box 1620
New York, NY 10029
Phone 212-241-8867
Table of Contents
 

Abstract

Coronavirus disease (COVID-19), caused by the SARS-CoV-2 virus, originated in Wuhan, Hubei Province, China in late 2019 and grew rapidly into a pandemic. As of the writing of this monograph, there are over 100 million confirmed cases worldwide and 2.3 million deaths.1 New York City, with over 630,000 COVID-19-positive patients and over 27,000 deaths, became the infection epicenter in the United States. The Mount Sinai Health System, with 8 hospitals spread across New York City and Long Island, has been on the forefront of the pandemic. This compendium summarizes the lessons learned through interdisciplinary collaborations to meet the varied challenges created by the explosive appearance of the infection in our community, and will be updated continuously as new research and best practices emerge. It is our hope is that the collaborations and lessons learned that went into creating these guidelines and protocols can serve as a useful template for other systems to adapt to their fight against COVID-19.

Introduction

This monograph summarizes the evaluation, treatment, and disposition tactics the Mount Sinai Health System created and implemented to help manage a new disease that posed an unprecedented volume of critical patients and had no known treatment. While by no means all-encompassing, the methods outlined here are focused on the front-line emergency clinician. We provide a rubric of how to think about major decisions regarding workup, treatment, and disposition. There is a focus on providing fundamental care in a way that maximizes safety for both patients and clinicians. Discussions regarding personal protective equipment (PPE), operational flow, and nonmedical resources are beyond the scope of this monograph. Although not discussed in detail, many of the nodal points in clinical decision-making can likely be performed by both telemedicine and advanced practice providers.

Most of the protocols presented here were developed by an interdisciplinary team of emergency physicians, infectious disease specialists, and intensivists. Incorporated into the tables is a combination of information coming out of Italy and China, local information obtained within an 8-hospital system in New York City with both community and academic sites, extensive discussion with emergency medicine experts around the country, and literature searches focused primarily on acute respiratory distress syndrome (ARDS) and analyses from prior viral outbreaks, including SARS, MERS, and H1N1.

Disclaimer: While the recommendations presented in this monograph are based on the best evidence available at the time of their creation, we acknowledge that our understanding of COVID-19 is changing daily. The protocols presented were developed by individuals, and though adopted by our Health System, the protocols are not necessarily endorsed by the Mount Sinai Health System, but are the independent product of the authors. We note that there is controversy, and that some of the recommendations may be controversial. We thank our many colleagues for their input, and we have tried, to the best of our ability, to note the sources from which protocols were adapted.

Section 1. Laboratory Testing and Imaging

While laboratory testing and imaging may assist with management and prognosis, they are generally adjuncts to the history and physical examination and rarely change initial management, especially in the well-appearing patient.

While clinical management for patients with COVID-19 continues to evolve and change on a nearly a daily basis, we have come to some clinical equipoise regarding laboratory studies and imaging. Laboratory studies are generally not required for the well-appearing patient under investigation with few or no risk factors. When drawn for concerning presentation in the emergency department (ED), labs are fairly standard, with the addition of inflammatory markers if the patient is expected to be admitted to the hospital. Although many are nonspecific, some may offer assistance in diagnosis, pending confirmatory testing.

Troponins may be elevated due to myocarditis or ischemia (demand or thrombosis). The basic metabolic panel may show electrolyte abnormalities due to dehydration or medication noncompliance; renal injury due to inflammation, vasculitis, and thrombosis has also been reported. The inflammatory markers will allow the inpatient team to trend them and potentially aid in directing therapy. Because knowledge is continuously evolving and there are often local protocols, a discussion with inpatient leadership may help guide which markers may be useful.

We use imaging less as a primary diagnostic tool than to rule out other diagnoses and to measure extent and progression of disease. Similar to laboratory testing, low-acuity patients without tachypnea, hypoxia, or more than minimal shortness of breath do not necessarily require imaging. In the early days of the pandemic, when the availability of PCR testing was limited, the use of CT scans was often substituted as a diagnostic modality.2 With PCR testing more readily available, CT scanning is less useful for diagnosis, although it may be more sensitive than some current PCR testing.3 Despite its impressive sensitivity, the resources required for multiple diagnostic CTs, especially in the time of pandemic, makes this an implausible diagnostic modality.

Table 1. Basic Laboratory Testing for COVID-19

Table 1. Basic Laboratory Testing for COVID-19

Table 2. Imaging Diagnostics for COVID-19

Table 2. Imaging Diagnostics for COVID-19

Table 3. Different Testing Criteria

Table 3. Different Testing Criteria for COVID-19

Section 2. Disposition/Admission Criteria

The variation in clinical presentation and course of COVID-19 poses a unique challenge in safely dispositioning patients from the ED. Given that respiratory distress may present as a late finding in the second week after initial onset of symptoms, decisions as to whether to admit or discharge patients must include a thorough evaluation of all relevant risk factors as well as the patient’s capacity to self-monitor and isolate at home. Discharge must also assess whether appropriate outpatient follow-up is available as well as the ability to return if the patient worsens.7 It is a given that some patients will worsen and require hospitalization; however, resources and safety considerations often preclude routine admission. While the absolute criteria for admission include signs and symptoms of respiratory distress or developing sepsis, the patient’s medical history and overall conditioning should also be taken into account on a case-by-case basis. While mortality is known to be higher among certain groups of hospitalized patients (eg, age > 65 years and patients with chronic cardiovascular, pulmonary, liver, renal diseases, etc) it is not yet fully clear which patients will decompensate as outpatients.8-11

Patients with suspected or confirmed COVID-19 who are not exhibiting increased work of breathing, tachypnea, or evidence of hypoxia may be managed in the outpatient setting with follow-up as needed for any new or worsening symptoms. One useful strategy is to ambulate patients prior to discharge to confirm that their oxygen saturation remains stable. Although this is not a proven strategy at this point, anecdotally it has been very helpful in finding unexpected hypoxia. Patients who are admitted for respiratory distress may be considered for discharge after 48 hours if they remain clinically stable. Persistently hypoxic patients without increasing supplemental oxygen requirements who do not have other significant risk factors may also be considered for discharge on home oxygen or with an oxygen concentrator. While higher mortality was associated with oxygen saturations <92% on ambient air or respiratory rates >24 breaths/min, borderline objective findings in COVID-19 patients have less predictable clinical outcomes.9 Traditional approaches, such as observation units, may not be available or may increase the risk of cross-contamination with other patients. If available, scheduling patients for 24-hour telemedicine follow-up appointments may provide an expedient strategy for safely discharging patients with mild dyspnea or hypoxia, in order to closely monitor them for any signs of decline while reducing overcrowding and nosocomial transmission in the ED.

Table 4 provides a list of the risk factors associated with the potential for clinical deterioration and thus need for hospitalization. Table 5 provides the context for which patients might be safe for discharge with close outpatient monitoring. We are currently assessing our experience with this pathway to find whether it has been successful in both decreasing admissions and providing safe discharges.

Table 4. Risk Factor Assessment for COVID-19

Table 4. Risk Factor Assessment for COVID-19

Table 5. Disposition Criteria Based on Risk Factors and Clinical Findings for Patients With Confirmed or Suspected COVID-19

Table 5. Disposition Criteria Based on Risk Factors and Clinical Findings for Patients With Confirmed or Suspected COVID-19

Section 3. Cardiac Arrest Protocol

With the ongoing pandemic, there are inevitably cardiac arrests associated with caring for the COVID-positive patient. Cardiopulmonary resuscitation (CPR), by its very nature, is an aerosolizing procedure. Whether this is from intubation, compressions, or bagging the airway, they all pose a real risk to staff. Also, given that a resuscitation can often be labor-intensive, it becomes even more important to minimize exposure. Therefore, a protocol to ensure the best care of the patients while protecting front-line staff must be followed. Risks and benefits for each case must be assessed, as overall favorable neurological outcome following CPR in many cases has been found been found to be < 1%.12 In Wuhan, a case series of in-hospital cardiac arrest found that, while most arrests were respiratory in nature, only 1 person out of 136 survived neurologically intact to discharge. 12 While the data are still not extensive, especially on neurologically intact discharges, the outcome of inhospital cardiac arrest in COVID-19 patients is similarly poor.13

We have recommended the use of a mechanical CPR device (mCPR) to minimize the number of staff in the room. Again, while the studies for mCPR have been mixed, at best, the balance between safety and treatment must be maintained.14,15 Likewise, the protocol limits the amount of equipment contaminated during resuscitation. Equipment shortages are inevitable when dealing with a pandemic, and resources must be guarded.

Table 6. Cardiac Arrest Protocol: Out-of-Hospital Cardiac Arrest

Table 6. Cardiac Arrest Protocol: Out-of-Hospital Cardiac Arrest

Section 4. Medication Treatment Guidelines

Although many pharmacologic agents are undergoing urgent investigation for use in patients with COVID-19, no curative or preventative treatments have been confirmed. At this time, medications targeted against SARS-CoV-2 and COVID-19 should generally be applied in the context of a clinical trial.16 While discussions of inpatient medications and current trials are beyond the scope of this monograph, recommended information sources include the CDC  and the NIH.

ED treatments are typically focused on symptom control and treatment of the manifestations of the disease (eg, shortness of breath, fever, pain). An electrocardiogram (ECG), basic coagulopathy biomarkers, and an assessment of kidney and liver function are generally performed in the ED, as some of the inpatient treatment may affect or be affected by other organs.

Advanced treatments are not usually started in the ED. Patients admitted should be screened for additional treatments or research studies. For severe cases of COVID-19, convalescent plasma, immunomodulators (tocilizumab and sarilumab), and antivirals such as remdesivir should be considered in the setting of clinical trials or appropriate clinical protocols.17 The effectiveness of these and other antimicrobial agents has yet to be determined, and they remain under active investigation. Monoclonal antibodies have recently received emergency use authorization for high-risk nonadmitted patients and are currently being administered in some EDs. Recommendations for the use of alternate or adjuvant therapies may change, as the literature on COVID-19 continues to evolve rapidly.

Please note that in this document, The Mount Sinai Health System is currently recommending steroids and prophylactic dose anticoagulation in admitted patients who do not have contraindications, based on evolving literature.18-20 The evidence is changing constantly, and we recommend regular review of practice.

Table 7. Medication Treatment Guidelines for SARS-CoV-2 Infection (COVID-19) in the Emergency Department

Table 7. Medication Treatment Guidelines for SARS-CoV-2 Infection (COVID-19) in the Emergency Department

Section 4a. Anticoagulation Protocol

The exact mechanisms and pathophysiology of how COVID-19 attacks the human body are incompletely understood. However, there is an increasing amount of evidence that COVID patients are in a hypercoagulable state, with autopsy evidence of microthrombi seen throughout the body, including the lungs, brain, heart, kidneys, and other organs.1 Anecdotally, we are seeing significant numbers of pulmonary emboli, although it is unclear whether this is related to the disease or critical illness. These patients may show abnormalities including elevated D-dimer, fibrinogen, and abnormal thromboelastography. One recent Dutch study of COVID-positive ICU patients found a 31% incidence of thrombotic complications.22 While the literature is evolving, it does not appear at this time that there is clear evidence for prophylactic full-dose anticoagulation, although prophylactic-dose anticoagulation should generally be used in all admitted patients without contraindications.19

Section 4b. Monoclonal Antibody Therapy

Monoclonal antibody therapy can be used to treat nonhospitalized patients with mild to moderate symptoms of COVID-19. Bamlanivimab is a monoclonal antibody directed toward the spike protein of SARS-CoV-2. The data show the potential to decrease progression to severe disease, but only when administered early in the course of the disease.21 Because bamlanivimab is currently approved by the FDA under an EUA, it is critical that all patients be screened to meet strict inclusion/exclusion criteria. (See Table 8.) Our Hospital system has set up a dual pathway where, during weekday hours, patients can be referred to the infusion center for treatment. To maximize benefit for patients by delivering treatment as early as possible, all EDs in the Health system are able to treat patients who meet EUA criteria with bamlanivimab while the patients are still in the ED.

Table 8. Inclusion and Exclusion Criteria for Bamlanivimab Treatment Under Emergency Use Authorization

Table 8. Inclusion and Exclusion Criteria for Bamlanivimab Treatment Under Emergency Use Authorization

Section 5. Intubation Protocol

COVID-19 is a disease with multiple manifestations; however, the common manifestation of acute respiratory disease is what leads to most concerning ED presentations. A minority—but concerning number—of patients will have profound acute hypoxic respiratory failure and ARDS.23-26 In addition to concerns about aerosolization of the virus during noninvasive ventilation and high-flow oxygenation, the timing and early need for intubation of hypoxic patients remains controversial.27 However, initial early intubation strategies have evolved to include expanded use of noninvasive ventilation and proning to try to delay or prevent intubation. When intubation is being contemplated, it is also very important to address goals of care with the patient and family, as current data show high mortality for intubated patients, especially with increased age and medical comorbidities.

Currently, we are using a stepwise approach to respiratory management for the COVID-19 patient. Patients with pure hypoxemia will be up-titrated from room air, to nasal canula, to non-rebreather, and HFNC. Patients with increased work of breathing and tachypnea despite supplemental oxygen are candidates for a trial of CPAP/BiPAP with close monitoring. If possible, CPAP/BiPAP and HFNC should be used in negative-pressure, closed rooms. A room with a closed door (or within a full COVID-19 unit) with all providers using N95 masks, is an option if negative pressure is not available. Additionally, a surgical mask can be placed over the HFNC to help decrease the amount of aerosolization. If intubation is necessary, the Mount Sinai Health System has developed a systemwide protocol for airway management as a collaboration between the Department of Emergency Medicine, the Institute for Critical Care Medicine, and the Department of Anesthesiology.3 This protocol was based on recommendations from both the Society of Critical Care Medicine and the American Society of Anesthesiologists. They have been updated regularly, with both new data and experience gained taking care of COVID patients.28-31

Table 9. Intubation Protocol

Table 9. Intubation Protocol

Section 6. Nonaerosolized Asthma Protocol

EDs in the United States see over 1.5 million visits per year for obstructive lung disease.32 We are now aware that some of those most affected by COVID-19 have been patients with intrinsic lung disease.33,34 Because aerosolizing procedures, such as nebulization of albuterol or ipratropium used for treatment of lung disease, cause dissemination and spread of viral particles, we have created a COPD/asthma protocol that minimizes these therapies.34 The protocol is designed to maximize treatment efficacy while ensuring safety of staff and providers. Within this protocol, breath-actuated nebulizers (eg, AeroEclipse®) can be used interchangeably with an albuterol (+/- ipratropium) MDI and spacer. Should a patient require respiratory support with noninvasive ventilation, this should ideally be done within the confines of a negative pressure room.

Special thanks to Sean Hickey, MD from the Icahn School of Medicine at Mount Sinai, whose work was critical in developing the guidelines in Tables 10 and 11

Table 10. Asthma Protocol for the Stable Patient With Moderate to Severe Symptoms

Table 10. Asthma Protocol for the Stable Patient With Moderate to Severe Symptoms

Table 11. Asthma Protocol for the Crashing Decompensated Patient

Table 11. Asthma Protocol for the Crashing Decompensated Patient

Section 7. Acute Dyspnea/Palliative Care Treatment/Goals of Care Discussions

While palliative care should not be equated with hospice or immediate end-of-life care, providing palliation to ill patients with COVID-19 implies a low chance of survivability.7,35 In these cases, palliation is often focused on providing appropriate, proportional pharmacological management of pain, dyspnea, agitation, and other common symptoms to maximize patient comfort at the end of life. Interventions should be titrated to observed or reported symptoms and not based on specific physiologic parameters. The flow sheet in Figure 1 represents a simple approach to dyspnea and agitation.

Given the high mortality with COVID-19 in the critically ill, an early discussion with patients and their families is highly recommended. Although increasing mortality is associated with underlying chronic medical conditions such as pulmonary, renal, and cardiac conditions, the absolute mortality is still unclear and studies may have incomplete data, given the relative newness of the disease. Scales such as the Sequential Organ Failure Assessment (SOFA) score may assist with offering some sense of prognosis. Overall, critically ill patients older than 70 years who require intubation have a reported mortality > 60%.36,37

Special thanks to Dr. Claire Akuna and Dr. Christopher Richardson and the Brookdale Department of Palliative Care at the Icahn School of Medicine at Mount Sinai who provided invaluable help with this guideline and review of palliative care assistance.

Figure 1. Acute Dyspnea Palliation Algorithm

Figure 1. Acute Dyspnea Palliation Algorithm

Section 7a. Death Management Talking Points

The COVID-19 pandemic has caused a radical shift in the practice of emergency medicine, and operational and communication issues have emerged that had not been encountered previously. Emergency physicians have had to quickly have goals-of-care discussions as well as break bad news to family members. While emergency clinicians are familiar with these types of discussions, the large numbers in a short period of time can become overwhelming. In addition, New York and other hard-hit areas have had the number of deaths exceed morgue and funeral home capacity. Families are understandably upset by these occurrences. We have included scripting that is designed to help with these difficult conversations.38

Table 12. Talking Points for Death Conversations

Table 12. Talking Points for Death Conversations

Table 13. Strategies for Making Patient-Centered Recommendations About Intubation and Code Status for Patients Who Are at High Risk for Poor Outcomes

Table 13. Strategies for Making Patient-Centered Recommendations about Intubation and Code Status for Patients Who Are at High Risk for Poor Outcomes

References:

Ouichi K, Lawton AJ, Bowman J, et al. Managing code status conversations for seriously ill older adults in respiratory failure. Ann Emerg Med. 2020;76(6):751-756.

Ariadne Labs. Simulated Virtual Visit Demonstration of COVID-19 Conversation Guide for Inpatient Care. April 2020. Accessed February 4, 2021.

Section 8. COVID-19 Smart Phrase/ Discharge Plan for Likely COVID-19 Patients

In order to rapidly chart and provide an overview with common ED patient presentations, smart phrases based on common presentations were developed. These were developed for use in the Epic electronic health records system, but can be adapted for any system. Included below are modified phrases for discharged COVID patients, tent/telehealth evaluation, and consultation template.

Table 14. COVID-19 Smart Phrases

Table 14. COVID-19 Smart Phrases

Table 15. Discharge Instructions for Likely COVID-19 Patients

Table 15. Discharge Instructions for Likely COVID-19 Patients

Please see the resources below for more information:

Local (DOH)

Local DOH Office Phone Numbers

  • Nassau County: (516) 227-9500
  • New York City: (347) 396-4131
  • Rockland County: (845) 364-2512
  • Suffolk County: (631) 854-0100
  • Westchester County: (914) 864-7292

Centers for Disease Control

Section 9. Guidelines for Prone Positioning of Nonintubated Patients

For hypoxemic patients, there are many physiologic benefits to the prone position. These include better matching of pulmonary perfusion to ventilation, better recruitment of dependent areas of the lung, and improved arterial oxygenation. In addition, there is evidence that the prone position results in a more homogeneous distribution of stresses in the lung and thus may prevent patients with hypoxemia from developing frank respiratory failure. Prone positioning is used extensively in the ICU to treat intubated patients with hypoxemic respiratory failure,39,40 but the benefits cited above may apply to nonintubated patients as well. For this reason, patients presenting with hypoxemia should be encouraged to adopt the prone position, where practical. Prone positioning may be tried as a rescue therapy in patients with escalating oxygen needs, although this will require close monitoring.41

Special thanks to Dr. Susan Wilcox and Dr. David Brown, and the Department of Emergency Medicine at Massachusetts General Hospital in Boston, MA, from which this guideline was largely adapted.

Table 16. Proning of Nonintubated Patients

Table 16. Proning of Nonintubated Patients

Section 10. Critical Care for ED COVID-19 Patients

Despite being confronted with a novel virus where evidence-based treatments are still lacking, it must be emphasized that proper critical care remains the cornerstone of current management. COVID-19 has an observed case-fatality ratio of 4.9% in the United States. Although this is based on sicker patients who are tested, at a minimum it should emphasize that the provision of high-quality critical care is imperative.42 Management of shock and hypoxia are the focus of COVID-19 critical care.

Norepinephrine and vasopressin are the vasopressors of choice as per standard of care.43-45 We recommend the prioritization of early vasopressors use in the management of these patients’ hypotension and only judicious use of volume, given their tenuous respiratory status.46,47 If available, point-of-care bedside ultrasound is extremely useful to assess cardiac function and volume status and to guide resuscitation.

Ventilator management is largely grounded in a lung-protective strategy. While debates rage regarding the nature of the disease and best practices for ventilatory management, we recommend the ARDS Clinical Network Ventilation protocol.48 Rescue strategies have been included in our guidelines for difficult-to-oxygenate patients. Patients must be synchronized with the ventilator to maximize our ability to oxygenate them; a RASS score of -2 to -3 is to be targeted. Should the patient remain hypoxic, a trial of paralysis can be attempted to improve oxygenation.45 Prone positioning of intubated patients to improve oxygenation is safest in the ICU with clinicians and teams that are experienced with the practice.40 Repositioning the patients into a lateral decubitus positioning may be a safer halfway mark to attempt in the ED while patients are waiting for an ICU bed. If rescue maneuvers fail, ECMO should be considered, if available.

Table 17. Troubleshooting for Intubated Patients

Table 17. Troubleshooting for Intubated Patients

Table 18. Acute Respiratory Distress Syndrome Management in COVID-19 Patients

Table 18. Acute Respiratory Distress Syndrome Management in COVID-19

Table 19. Shock Management in COVID-19 Patients

Table 19. Shock Management in COVID-19

Table 20. Ventilator Management for COVID-19 Patients

Table 20. Ventilator Management in COVID-19

Table 21. Diagnostics in Critical Care of COVID-19 Patients

Table 21. Diagnostics in COVID-19 Critical Care

Table 22. Respiratory Management in COVID-19 Patients

Table 22. Respiratory Management in COVID-19

Section 11. Return-to-Work Criteria

Table 23. Return-to-Work Criteria

Table 23. Return-to-Work Criteria

Selected Web Resources

NIH COVID-19 Treatment Guidelines

NIH ACTIV Trial of blood thinners pauses enrollment of critically ill COVID-19 patients

BWH QUICK-REFERENCE GUIDE - COVID-19 Outpatient Management

UW Medicine COVID-19 Resource Site

Food and Drug Administration. EUA 26382: emergency use authorization (EUA) request. 2020.

Food and Drug Administration. EUA of COVID-19 convalescent plasma for the treatment of COVID-19 in hospitalized patients: fact sheet for health care providers. 2020. Accessed 1/5/21

CDC - Performance of an Antigen-Based Test for Asymptomatic and Symptomatic SARS-CoV-2 Testing at Two University Campuses - Wisconsin, September–October 2020

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