American College Of Surgeons - Inspiring Quality: Highest Standards, Better Outcomes

Clinical Issues and Guidance

Promising Therapeutics

The Milken Institute has launched a COVID-19 Treatment and Vaccine Tracker, which lists 79 treatments, as well as 49 vaccines in development. This list details the type of treatment or vaccine being studied or developed, as well as the anticipated timeline, including when certain phases are expected to kick off or when data is anticipated.

In addition, two reports have been released recently on hot issues in treatment of COVD-19 patients. They are as follows:

  • A recent report, yet to be peer reviewed, focuses on the use of hydroxychloroquine (HCQ) in COVID-19 patients. A small (62 patients) randomized controlled trial of the addition of 400 mg/day of HCQ to standard care versus standard care only in hospitalized patients with mild disease revealed a significant but slight improvement in time to clinical recovery and a favorable impact on pneumonia. Four of the 62 patients progressed to severe disease—all in the standard (non HCQ) group.
  • An article in the New England Journal of Medicine reported on a randomized controlled open-label clinical trial in severe COVID-19 disease evaluating the addition of lopinavir and ritonavir with standard supportive care. It revealed that the addition of lopinavir and ritonavir did not improve time to clinical improvement or the mortality of the disease (19.2 percent versus 25 percent). Lopinavir/ritonavir had to be stopped in 13.8 percent of the patients in that arm due to adverse events.

Preparing for a Ventilator Shortage

The COVID-19 pandemic in the U.S. may unfortunately lead to a shortage of ventilators in hospitals. It is therefore important to consider and make preparations for how local facilities will make allocation decisions. While the March 31 ACS Newsletter contained an Ethical Framework for the Allocation of Resources in the Event of Shortage, this section offers more granular operational details of preparing for a potential ventilator shortage.

The following are key items to discuss, evaluate, and plan. 

  • Creating an allocation triage team. This team will evaluate and triage patients—it is advantageous to alleviate the bedside clinician from the triage decision-making process. Creating this team will include identifying disciplines, criteria, members, and shifts, among other things.
  • Identifying criteria for evaluation/scoring of patients. The goal is to define an objective (or objective as possible), transparent patient assessment. This is opposed to an arbitrary/subjective criteria. For ventilators, an example is the calculation of a SOFA score, with or without modification with additional factors such as age, comorbidities, health care worker, other)
  • Consideration of a two-layer evaluation (e.g. first layer triage team, second layer oversight group) to optimize objectivity, fairness, and consistency.
  • Review of prior decisions to ensure consistent application and use of the protocol and scoring criteria. 
  • Periodic (e.g. daily, every other day) recalculation of patient score. This practice will provide standardized scores to evaluate change in condition. 
  • Protocol for communication of triage decision to family (options include triage team/member vs bedside clinician versus combination versus other).
  • Daily evaluation of the scarce resource (e.g. available ventilators).

A comprehensive document is available that provides details for the above issues and others. With potential patient peaks predicted to occur in the coming weeks, we strongly suggest that hospitals discuss and operationalize how allocation would be implemented locally. Subsequent newsletters will include examples of allocation protocols from various facilities. 

Tracheostomy: Safety-First Approach

Tracheostomy and airways remain a serious problem, especially for hospitals in the overwhelmed status. Two articles give guidance on this issue. We realize that in the moment not all of these precautions may be available. As the surgical workforce continues to adapt and respond to the seemingly innumerable challenges of the COVID-19 pandemic, two newly published articles in JAMA Otolaryngology-Head & Neck Surgery, offer insight into the “safety-first” approach to head and neck interventions in patients with COVID-19 infection: Safety Recommendations for Evaluation and Surgery of the Head and Neck During the COVID-19 Pandemic and Surgical Considerations for Tracheostomy During the COVID-19 Pandemic: Lessons Learned From the Severe Acute Respiratory Syndrome Outbreak. Of particular interest to acute care surgeons are the recommendations for the initial evaluation of facial trauma and for performance of tracheostomy. The articles emphasize the considerable risk to providers during evaluation of patients with open facial fractures and mucosal surface lacerations, and during aerosol-generating procedures such as tracheostomy and postoperative tracheostomy care.

Grady Memorial Hospital Issues Guidance on COVID-19 Tracheostomy Process

It is important to be prepared to operate on COVID-19-positive patients or COVID-19 persons under investigation (PUIs) to guarantee the safety of our patients and staff. Grady Memorial Hospital, Atlanta, GA, has developed recommendations that are based on the latest Centers for Disease Control and Prevention guidelines on personal protective equipment and expert consensus of the American Association of Bronchoscopy and Interventional Pulmonology COVID-19 Task Force dated March 12, 2020.

Optimizing Ventilator Use during the COVID-19 Pandemic

The U.S. Public Health Service issued a directive March 31 directive outlining aggressive measures for optimizing ventilator use during the COVID-19 pandemic that addresses the problems and mechanics of coventilating two patients with a single mechanical ventilator. The document cautions against co-venting but provides crisis care decision-making guidelines, a consensus statement on the concept of co-venting, Federal Emergency Management Agency-developed technical documents, a ventilator-sharing protocol developed by Columbia University, along with Centers for Disease Control and Prevention and Food and Drug Administration comments.

Surgical Chairs Point to Need for Redeployment Plan; University of Pennsylvania Offers One Model

Many hospitals and health systems are working to develop a regional redeployment model that supports an engaged workforce to respond to the COVID-19 pandemic. A pilot survey querying the members of the Academic Orthopedic Consortium (AOC—an organization which that represents almost every academic orthopedic program in the United States) was distributed inquiring about workforce redeployment and post COVID ramp up. The same questionnaire was sent to Robert Higgins, MD, FACS, President of the Society of Surgical Chairs (SSC), for distribution to his society’s members. 

There were 74 responses by the SSC and a completion rate of 89 percent. As of April 1, 82 percent of programs said that their health systems and hospitals are asking them for a redeployment plan for both faculty and residents.

When querying about the areas of care delivery that the faculty and residents were being asked to cover, 50 percent of the respondents said that their staff would be used for ICU care, 24 percent for the emergency room, 17 percent for patient screening, and 9 percent for walk-in clinics.

With regards for plans for "ramp up” after the threat of virus transmission wanes and hospital beds come back online for elective surgery, 42 percent said they would consider Saturday or Sunday hours and clinics, 19 percent extended hours, 7 percent said they would keep or expand TeleMedicine, and 32 perecent had no plans as of yet. Variables include the incidence in particular regions of the people that are jobless and therefore without insurance and this certainly could affect the size of the rebound. 

The health of the workforce both surgery anesthesia and ancillary personnel will also have a bearing on each institution’s ability to ramp up.

This preliminary data from specialty surgeons and general surgeons can provide strategy to further delineate health system needs and best practices with regards to redeployment and ramp up. 

A task force could begin working on the ramp up issue now in order to be prepared for re engagement of surgeons, trainees, and health care workers. 

Royal College of Surgeons Releases COVID-19 Guide for Surgeons and Surgical Teams

The Royal College of Surgeons has published a guide—COVID-19: Good Practice for Surgeons and Surgical Teams—that contains broad recommendations to support surgeons and surgical teams as they respond to the outbreak. The guide centers on four areas: adapting surgical services, working in an extended scope of practice, caring for patients at the end of life, and protecting the workforce.

ELSO Issues Guidance on ECMO for COVID-19 Patients with Severe Cardiopulmonary Failure

The Extracorporeal Life Support Organization (ELSO) and its chapters have prepared a document that describes when and how to use extracorporeal membrane oxygenation (ECMO) in COVID-19 patients. It is a consensus guideline intended for experienced ECMO centers. Because COVID-19 is a new viral disease, this guidance document is based on limited experience and written with the intention to be updated frequently as new information becomes available. The latest version of this document is available on the ELSO website.

GPS Issues Guidance on Gastroenterology Procedures

The Gastroenterology Professional Society, a consortium of organizations that represent physicians who provide care to gastroenterology patients, has issued guidance regarding the management of clinical procedures during COVID-19. The guidance calls for delaying elective procedures and continuing to conduct emergency operations. It also answers frequently asked questions and noted that any decisions should be informed by the local situation and available resources.

U.S. Military, USU-WR Surgery Issue Guidance on Postponement of Elective Surgery during COVID-19

The U.S. Department of Defense (DoD) and the Uniformed Services University Walter Reed (USU-WR) Surgery recently issued guidelines for surgical care during the COVID-19 epidemic.

The Assistant Secretary of Defense for Health Affairs, recently sent a memorandum to the Assistant Secretaries of the U.S. Army, U.S. Navy, U.S. Air Force, and Defense Health Agency stating that all elective operations, invasive procedures, and dental procedures performed at Military Treatment Facilities (MTF) and Dental Treatment Facilities (DTF) should be postponed, with certain exceptions. The policy went into effect March 31 and will remain in place for 60 days from that date.

This directive was made to align with actions being taken across the country in civilian hospitals to preserve critical resources and to prevent the spread of COVID-19 to hospital personnel.

The DoD released a fact sheet summarizing the temporary policy.

SGO Provides Guidance for Potential Reassignment

The Society of Gynecologic Oncology (SGO) has issued guidance to assist members facing potential reassignment outside the practice of obstetrics and gynecology during the COVID-19 pandemic. These recommendations underscore the importance of the efficient use of medical and surgical staff, and suggest gynecologic oncologists can be used to provide the following services: Obstetrical hemorrhage support, urgent and emergent benign surgery, urgent and emergent cancer surgery, urgent and emergent surgical consults by other hospital services, and Cesarean delivery support. The SGO provided this guidance to support medical and surgical staff in their discussions with hospital leadership concerning potential reassignment.

EAES Updates Recommendations on Caring for COVID-19 Patients

The European Association for Endoscopic Surgery (EAES) has released updated information—including instructional videos and links to scientific articles—regarding the surgical response to the COVID-19 crisis. Topic areas include updated guides for open, laparoscopic and endoscopic procedures, rational use of face masks during the pandemic, and practical advice for producing 3-D printed components for ventilation systems.

EAES—in collaboration with the Society of American Gastrointestinal and Endoscopic Surgeons—has produced an infographic that summarizes primary recommendations for treating patients with COVID-19. These joint recommendations suggest all health care staff wear personal protective equipment, postpone elective cases, and establish an operating room dedicated to COVID-19 cases.

How to Set Up a Regional Medical Operations Center to Manage the COVID-19 Pandemic

The COVID-19 pandemic has stressed health care systems across the globe and is now affecting many U.S. cities. The modeling from the University of Washington Institute for Health Metrics and Evaluation, Seattle, indicates we are still weeks away from the peak in the number of critically ill patients who will require hospitalization. Estimates as of April 2 suggest at peak capacity, a need for more than 260,000 hospital beds and more than 87,000 intensive care unit beds across the U.S. A new guidance document from the American College of Surgeons offers suggestions on how to establish a regional medical operations centers (RMOCs) to manage the surge in capacity. It outlines the necessary communications technology, health care personnel, and so on to establish and maintain an RMOC during a disaster.