I was waiting for my son at the ice rink in one of Chicago’s northern suburbs. Hundreds of people had gathered to watch the Illinois State Championship games. A parent, who knew I was an anesthesiologist, grabbed me by the elbow and said, “Hey, Doc, someone in the lobby is not feeling well.”
I went to the lobby, where I saw my firefighter friend performing chest compressions (CPR) on an older gentleman. I jumped in to help. A rink employee brought in an automatic external defibrillator (AED) device.
The protocol we followed is basic life support (BLS). The American Heart Association (AHA) developed the BLS protocol in the 1950s and 1960s. The AHA continually reviews the BLS protocol as more research data becomes available. The protocol is strict, and the steps are exact. A successful revival of a victim may also include the use of an AED. AEDs can restart a non-beating heart and have been proven highly effective in emergencies, increasing the patient’s chances of survival.
Unfortunately, the success rate of resuscitation outside the hospital is only about 12 percent, according to AHA data in 2016.
After the second AED shock and feeling no pulse, I realized that the outcome of this particular situation would most likely not be positive. Then I had an inspiration. I asked the crowd, “Does anyone happen to have an EpiPen?” Epinephrine is the first drug used in cases of cardiac arrest in the hospital. However, it is not part of the BLS protocol but the advanced cardiac life support (ACLS) protocol. ACLS is consistently implemented along with BLS in hospital settings.
Studies have shown that the efforts in out-of-the-hospital settings should be directed to reduce the time to initiate BLS and AED availability rather than trying to implement the much more complicated ACLS protocol. Therefore, established policies and guidelines concentrate on BLS and AED for out-of-hospital cardio-respiratory arrests.
However, I am an anesthesiologist. I am BLS and ACLS certified. My mind was on the next step. It was looking for epinephrine.
In response to my request, a young lady stepped forward from the crowd and gave me her EpiPen. I immediately jabbed it into the victim’s exposed shoulder. The firefighter paused the CPR, and a weak pulse was detected on the patient’s neck. CPR was resumed and continued until the paramedics arrived. The paramedics inserted a breathing tube into the patient’s windpipe and rushed him to the nearest hospital.
I had very little hope for this victim; the odds were heavily against him. Yet, that evening the president of the local hockey association reached out to me and said that the victim was undergoing a “procedure” at the hospital.
The following day, Rob (the patient’s name) awakened and seemed to be doing well. A few days later, Rob’s son called and emotionally thanked me for saving his father’s life.
In retrospect, we did what we were trained to do. We started BLS immediately and went through the out-of-hospital cardiac arrest protocol with one exception: the EpiPen. Epinephrine is not indicated for use in out-of-hospital settings, according to current AHA recommendations. Although several studies from highly respected sources have examined the possibility of introducing the ACLS into out-of-the-hospital settings, the general conclusion was that it would not provide any additional value. And the efforts and resources should instead be directed towards shortening the time between cardiac arrest and the start of BLS. The shorter this time, the more likely the victim will survive.
In our case, there was no delay in BLS administration — we took no unnecessary steps. A highly qualified individual went beyond the existing protocol, which may have saved Rob’s life. As a trained, experienced physician, I did what I always do in other settings, even though epinephrine was not in the recommended protocol.
Checklists, protocols, policies, and guidelines rule contemporary medical practice.
In the book The Checklist Manifesto, Atul Gawande — a surgeon — argues in favor of checklists. He believes that medical practice has become so complex that it is difficult for practitioners to make the right decisions every time without making a mistake.
The checklists Gawande mentions in his book were highly effective and significantly improved outcomes. Moreover, the results were reproducible in different settings. The checklists saved lives and money and provided a clear action plan.
But the checklists did not guarantee a 100 percent success rate.
It is imperative to understand today as the attitude of the current new physicians, nurses, medical residents, and students is rapidly changing toward the “we’ve done everything we could” mentality once protocols are exhausted. Outliers are in grave danger.
Dr. Gawande mentions the protocols and checklists that worked very well in his book. Yet, today various protocols and policies are adopted without proof of effectiveness.
On July 1, 2004, the Joint Commission mandated the adoption of the “universal protocol.”
The universal protocol consists of three parts:
- A pre-surgical verification process
- Surgical site marking
- Surgical “time-out” before the start of the procedure
Each of these parts has a description and requirements.
The universal protocol was supposed to be the ultimate safety checklist. Wrong-site surgeries were supposed to be eradicated, like smallpox.
Yet, the five-year results following the mandatory implementation of the universal protocol were disappointing. A 2009 paper in Patient Safety in Surgery indicated, “Despite the widespread implementation of the universal protocol since 2004, multiple reports have documented the continued occurrence of the wrong site and wrong patient procedures in the United States.”
According to the Joint Commission data, there were 597 reported sentinel events in 2005 and 824 in 2016. Among these, “wrong-patient, wrong-site, wrong-procedure” disasters were the most common. The article in Hand further elaborated, “The universal protocol has three principal components: preoperative verification, marking of the operative site, and a time-out. Despite this organized approach to this problem, current data do not demonstrate any progress. In fact, some data suggest that the problem may be getting worse.”
The universal protocol, with multiple modifications along with other policies and guidelines, continues to be mandatory. The health care providers are required to document, checkboxes, and report. We took the Joint Commission’s invention as the ultimate truth without questioning it. Indeed, it feels like the right thing to do. But the evidence is not there.
There was a very well-thought-out editorial article in Anesthesiology in 2017. Dr. Kirk Hogan of the University of Wisconsin made a fascinating point. He argued that when looking at the history of our medical subspecialty, there is a clear “demarcation” dividing the period of “an incredible quickening in the practice of anesthesia” that ended sometime around 1995 and the period when “innovations in anesthesia care from 1995 to the present have been less generous and of a different order, with the shift in focus from the introduction of disruptive technical advances in drugs and devices to the regulation of caregiver behaviors.”
Since 1995 anesthesiology has been bombarded with multiple regulations, protocols, and checklists. Dr. Hogan compares the innovations in anesthesiology before 1995 and afterward, and it is clear that the last two decades were dominated by introducing new rules requiring compliance. “Compliers do not innovate. Innovators do not comply. Within a culture of innovation, choices to be made in patient care expand. Within the culture of compliance, choices constrict.” Going beyond the established protocols to improve patient outcomes in such an environment becomes foreign.
Even in cases of “successful” protocols that Dr. Gawande mentions in his book, we must consider ways to improve outcomes for outliers. It becomes clear that there is a need for individual physicians to think about and analyze the data from individual patients. Medicine is a science and also an art.
No matter how noble the intentions are before widespread adaptation, any new protocol and policy has to show a statistically significant positive outcome that is reproducible and supported by contemporary evidence.
Yuri Aronov is an anesthesiologist.