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Despite the growth in use of procedural suites outside of the operating room, non-OR anesthesia (NORA) care remains a troubling concern for patient safety, experts say.

Non-OR procedure suites -- such as cardiac catheterization labs, interventional radiology suites, or gastroenterology suites -- continue to increase in number and caseload, leading anesthesiology providers and patient safety advocates to call for improved practice standards to address growing concerns over patient safety.

For years, Emily Methangkool, MD, MPH, vice chair of quality and patient safety at the University of California Los Angeles, has been sounding the alarm at medical conferences, warning a crisis may be on the horizon as non-OR procedures are expected to grow to more than 50% of all anesthesia cases in the near future.

"Malpractice claims in NORA compared to the operating room are more commonly associated with injury from respiratory issues, for example hypoxia or hyperventilation," Methangkool told 麻豆传媒. "That is more common in NORA because we are sedating the patients without a protected airway, so for a lot of these cases we are not putting a breathing tube in the patient [who is getting] sedation."

What Is NORA?

NORA is broadly defined as any anesthesia care provided in a setting that is not an OR. This can include interventional cardiology suites or cardiac catheterization labs, interventional radiology suites, or gastroenterology suites where endoscopies and colonoscopies are performed. NORA can also refer to outpatient or ambulatory surgery centers, and even occasionally medical offices.

Anesthesiologists have a complicated relationship with NORA care, said Jeffrey White, MD, an associate professor of anesthesiology at the University of Florida. It's characterized by problematic case schedules, long internal commutes between the main OR and procedure suites, and the lack of access to tools typically available in the OR, he said. (See this sidebar on the challenges of delivering anesthesia care in procedural suites.)

"It used to historically go by a bunch of other names like 'out of OR' and then, mnemonically, 'OOR,'" he said. "And not uncommonly and perhaps with a dismissive sort of epithet, it was called 'The Outback,' as if it was in Australia because you're sort of locked in the desert."

There are also concerns about the delivery of anesthesia care outside of a well-resourced OR, Methangkool said.

"Amongst anesthesiologists, it is well recognized that non-OR locations pose patient safety risks because we're working outside of the operating room with not-the-usual standards of equipment and monitoring and teamwork that we're used to," she said.

At the same time, the rapid rise in NORA has allowed specialists to treat patients who previously would have been considered too old or too sick for a longer surgery in the OR.

This combination of older sick patients undergoing new advanced procedures outside the OR -- where providers may not necessarily have the team or equipment they're used to working with, or where the anesthesia equipment might be in the wrong place -- "really poses the hazards to patient safety," said Methangkool.

Patient Safety Concerns

Patient safety concerns came to the forefront after a series of studies showed higher rates of complications and death with NORA cases versus regular OR cases.

using claims data showed that anesthesia cases conducted in "remote" locations had a significant increase in deaths compared to cases done in the OR (54% vs 29%, P<0.001). It also found that respiratory damage and inadequate oxygenation were more common in NORA cases.

Patient safety has since become a common phrase that accompanies any mention of NORA among anesthesia providers, Methangkool said. Several anesthesia groups have worked to create talks and recommendations for how to improve patient safety in NORA cases.

In fact, the journal Current Opinion in Anesthesiology dedicated last year to the myriad concerns that anesthesiologists have about working on NORA cases, including detailing the need for more strategic planning, checklists, and consistent staffing models specifically to help reduce pulmonary complications.

White is an author of one of those papers, but he acknowledged that have shown greater harm with NORA. Nonetheless, he said the logistics of NORA alone are a constant cause for concern among anesthesiologists.

"These patients are really too sick to have a big major open operation," he said, "Well, if they're too sick to be in the main OR, that does not reduce the risks, and so that became the issue."

In addition to treating higher-risk patients, anesthesia providers have also expressed concern about the environment of procedural suites. Methangkool noted that anesthesia providers are often stuck with suboptimal conditions, either due to a lack of space for anesthesia equipment or poor positioning for an anesthesia provider in relation to the patient.

"They didn't necessarily build [procedural suites] with anesthesia in mind," Methangkool said. "It's super, super important for patient safety."

Benefits of Procedural Suites

The flip side of patient safety concerns are the potential benefits to patients, said Aasma Shaukat, MD, MPH, a gastroenterologist at NYU Langone Health.

In gastroenterology, for instance, about 16 million colonoscopies and 18 million upper endoscopies are performed each year, Shaukat said. "We do them very well, very efficiently, they're safe, and they give us a variety of information for diagnostic purposes," she added.

The benefit of these procedures for patients is clear, but the sheer quantity in the gastroenterology suite has contributed to the additional pressure on anesthesia providers, Methangkool said.

Still, Shaukat said the need for anesthesia providers is relatively new, especially for colonoscopies. Colonoscopies used to be performed with moderate sedation, which did not require the assistance of an anesthesia provider, but a recent trend in the use of deep sedation has changed that practice.

The catch is that gastroenterologists cannot administer deep sedation, Shaukat said. This has created a major demand for anesthesia providers in gastroenterology suites and ambulatory surgery centers.

More Collaboration Needed

Anesthesiologists and patient safety advocates want to see more collaboration between anesthesiologists and the various specialties to help identify and address areas of concern with NORA cases. Methangkool noted that these concerns might not be felt by the specialists working on the cases in the same way though.

"From the gastroenterologists' perspective, from the interventional radiologists' perspective, they probably don't see it the same way because they see it just as, 'I'm doing my case in a location that I am used to, the patient just needs sedation, what is the big deal?'" she said.

This viewpoint might mean that gastroenterologists, cardiologists, and radiologists are not aware of the risks that could present during NORA cases.

Shaukat did acknowledge that there has been some research suggesting an increase in complications in these cases, but she said the effect has been "hard to tease out" from the complexity of the patients or procedures and the administration of deep sedation. She also noted that she has not seen a significant issue with anesthesia providers not having enough space or access to patients during colonoscopies.

Shaukat emphasized that having access to anesthesia care from anesthesiologists and certified registered nurse anesthetists (CRNAs) is essential to increasing patient access to these procedures. As more patients want these procedures done with deep sedation, she said, anesthesia providers are suddenly in short supply.

Despite the bottleneck for anesthesia care, Shaukat said NORA cases are likely to continue to increase because they are beneficial to patients, and patients want these procedures using deep sedation.

"Getting [patients] good access, getting them their procedures safely but efficiently, and in a timely manner, is important to us," Shaukat said.

Methangkool noted that all specialists involved in these cases need to focus on developing checklists and guidelines together to better address these overlapping concerns about NORA and patient safety.

"I think we still need to kind of bridge that gap from understanding from the anesthesia side to the proceduralist side," she said.

"As a specialty, we're very aware of the risks that NORA poses, and I think we are trying to, I guess, publicize that to our colleagues in medicine," said Methangkool. "We're making headway in a way that we haven't in the past decade, but definitely there needs to be more recognition."

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