ORIGINAL ARTICLE

Complications of Non–Operating Room Procedures: Outcomes From the National Anesthesia Clinical Outcomes Registry Beverly Chang, MD,* Alan D. Kaye, MD, PhD,† James H. Diaz, MD, MPH,†‡ Benjamin Westlake, BS,§ Richard P. Dutton, MD, MBA,§|| and Richard D. Urman, MD, MBA* Objectives: This study examines the impact of procedural locations and types of anesthetics on patient outcomes in non-operating room anesthesia (NORA) locations. The National Anesthesia Clinical Outcomes Registry database was examined to compare OR to NORA anesthetic complications and patient demographics. Methods: The National Anesthesia Clinical Outcomes Registry database was examined for all patient procedures from 2010 to 2013. A total of 12,252,846 cases were analyzed, with 205 practices contributing information, representing 1494 facilities and 7767 physician providers. Cases were separated on the basis of procedure location, OR, or NORA. Subgroup analysis examined outcomes from specific subspecialties. Results: Non-OR anesthesia procedures were performed on a higher percentage of patients older than 50 years (61.92% versus 55.56%, P < 0.0001). Monitored anesthesia care (MAC) (20.15%) and sedation (2.05%) were more common in NORA locations. The most common minor complications were postoperative nausea and vomiting (1.06%), inadequate pain control (1.01%), and hemodynamic instability (0.62%). The most common major complications were serious hemodynamic instability (0.10%) and upgrade of care (0.10%). There was a greater incidence of complications in cardiology and radiology locations. Overall mortality was higher in OR versus NORA (0.04% versus 0.02%, P < 0.0001). Subcategory analysis showed increased incidence of death in cardiology and radiology locations (0.05%). Conclusions: Non-OR anesthesia procedures have lower morbidity and mortality rates than OR procedures, contrary to some previously published studies. However, the increased complication rates in both the cardiology and radiology locations may need to be the target of future safety investigations. Providers must ensure proper monitoring of patients, and NORA locations need to be held to the same standard of care as the main operating room. Further studies need to identify at-risk patients and procedures that may predispose patients to complications. Key Words: anesthesia, non–operating room, outside the operating room, patient outcomes, complications (J Patient Saf 2015;00: 00–00)

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on–operating room anesthesia (NORA) is a term that comprises a diverse range of anesthetic care.1 Non-OR anesthesia refers to any location outside the traditional OR setting, such as the interventional cardiology, endoscopy, dental, or radiology

From the *Department of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts; †Department of Anesthesiology, Louisiana State University; ‡Environmental and Occupational Health Sciences, School of Public Health, Louisiana State University, New Orleans, Louisiana; §Anesthesia Quality Institute, Schaumburg, Illinois; and ||Department of Anesthesiology, The University of Chicago, Chicago, Illinois. Correspondence: Richard D. Urman, MD, MBA, Department of Anesthesiology, Brigham and Women's Hospital, Harvard Medical School, 75 Francis St, Boston, MA 02115 (e‐mail: [email protected]). The authors disclose no conflict of interest. Copyright © 2015 Wolters Kluwer Health, Inc. All rights reserved.

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suites. When delivering care outside the OR, trained anesthesia providers are faced with multiple, unfamiliar locations and often complex procedures that have their own unique perils. Many external factors are propelling care to NORA locations, including the emphasis on cost reduction, efficiency, and expansion of subspecialties (such as interventional radiologists and cardiologists) in which equipment requirements necessitate a unique space for each medical specialty.2 In recent years, NORA has seen a steady increase in volume with the development of improved noninvasive techniques and a patient population with significant comorbidities who are often not surgical candidates. Indeed, the ready availability of anesthesia services in these locations may be one of the driving factors for increased volumes and increasing complexity of NORA cases. Closed claims data from 2006 to 2009 analyzed by Metzner et al3 and Robbertze et al4 revealed an increase in NORA claims from 24 to 82 over just a few years. Non-OR anesthesia patients have been demonstrated to be older and more medically complex compared with the general OR population. In addition, the environment in which many NORA procedures are performed may hinder the delivery of safe anesthetic care.1,5 Such problems include remote locations with the lack of available skilled personnel, older and unfamiliar equipment, lack of drugs and supplies, and limited working spaces. For example, in radiology suites, access to patients during imaging procedures may become difficult, while room layouts may create significant difficulties for anesthesiologists.6 Non-OR anesthesia locations often use sedation practices by non–anesthesia providers, which, without proper monitoring and training, can be potential sources of significant injury. Pino7 examined a series of non-OR cases from a tertiary care center and identified the most common complications associated with sedation by nonanesthesiologists, including death (0.007%), cardiac arrest (0.06%), anesthetic assistance (0.01%), apnea or use of drug-reversal agents (0.12%), and hypoxia with O2 of less than 90% (0.12%). With recognition of the need for improved outcomes data collection, the Anesthesia Quality Institute (AQI) created the National Anesthesia Clinical Outcomes Registry (NACOR) with the support of the American Society of Anesthesiologists (ASA). The goal was to establish a database resource for anesthesiologists looking to assess and improve patient care.8–10 Established in 2008, NACOR's goal was to track procedural data and outcomes. Since that time, significant amounts of data regarding all aspects of anesthesia care including NORA have been accumulated. It is now the largest anesthesia registry in the country.8 Patient demographics and baseline health status can affect outcomes for anesthetics in any location.11,12 However, few studies have identified patient demographics in each of the OR and nonOR anesthetic locations.3,13 In addition, the type of procedures and the types of anesthetics provided can also have significant impact on the anesthetic outcomes. This study examines and compares OR and NORA characteristics and outcomes data from the NACOR database. It aims to compare overall OR and NORA www.journalpatientsafety.com

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patient demographics, anesthetic types, and the differences in each of the major NORA subspecialties such as cardiology, radiology, and gastroenterology. In addition, we examine the incidence of specific complications based on procedural location.

METHODS The NACOR database was examined for all patient procedures from a 4-year period between 2010 and 2013. Non-OR anesthesia data were collected from anesthesia practices that voluntarily selfreport their deidentified provider and patient information to the AQI. This allows the practices to benchmark their care relative to other anesthesia groups around the nation. A total of 205 practices contributed information to NACOR, which represented 1494 facilities and 7767 physician providers. A total of 12,252,846 cases were examined from the registry. All anesthetics were performed by anesthesiologists or anesthesia personnel under the care team model (i.e., physician, certified registered nurse anesthetist, anesthesia assistant). The cases were separated on the basis of procedure location, which included OR and NORA. Subgroup analysis examined outcomes from specific NORA locations such as gastrointestinal, cardiology, and radiology suites. Cases were stratified into these location categories on the basis of Current Procedural Terminology (CPT) codes. The current NACOR database is formed from information that is voluntarily submitted on a monthly basis by participating practices. There are no enforced data submission criteria with which each practice needs to comply. As a result, a practice, for example, may choose to submit only demographic information but not outcomes. Other practices may submit data for only certain complications but not others. To reconcile these disparate data to ensure the quality of the results, this study included only data in which consistent reporting was provided throughout the year and in which clear outcomes were demonstrated. For example, if a mortality outcome (yes/no) was not clearly stated in a submitted case, this case was not included in the mortality analysis. However, this same case may have reported outcomes on postoperative nausea and vomiting and thus would be included in the analysis for this category. Aggregate data comparing main OR and non-OR anesthetics were examined. Analysis was performed, stratifying the populations on the basis of sex, age group, anesthetic type, minor/ major outcomes, and mortality outcomes. Non-OR anesthesia was further broken down by procedural locations. Anesthetics were placed into each of the NORA subcategories on the basis of the CPT codes billed for the procedures.

Description of Statistical Methodology All OR and NORA variables were recorded as exact counts from the NACOR database and then stratified by sex, age group, ASA Physical Status (PS), type of anesthetic administered, and adverse outcomes. The OR versus NORA counts were compared for statistically significant differences by χ2 contingency table analyses using the interactive calculation tool for chi-square tests of goodness of fit and independence available from http:// quantpsy.org. Yates corrections of χ2 values were not required for any comparisons because of the large sample sizes and the high cell counts. In addition to the χ2 tests, contingency table analyses were also used to calculate risk ratios (RRs).13 The purpose of the RR, defined as the ratio of the probability of an event occurring in the NORA group compared with the probability of an event occurring in the OR group, was to address the null hypothesis of no difference in the probability of adverse outcomes occurring in NORA compared with OR. The RRs were bracketed with 95% confidence intervals (CIs). Risk ratios were calculated using the

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Practical Meta-Analysis Effect Size Calculator available at http:// www.campbellcollaboration.org/escalc/html/ EffectSizeCalculator-OR1.php. Results were reported as exact counts, χ2 values and their P values, as well as RRs and their 95% CIs. Statistically significant differences were indicated by P ≤ 0.05. In addition, RRs greater than 2.0 to 2.5 were considered as posing significant risks (or 2.0–2.5 times the likelihood of the outcome) and RRs near 1.0 were considered as posing little risk. A post hoc power and sample size analysis identified comparative sample sizes of 1605 counts for 80% power and 2135 counts for 90% power. For most comparisons, the sample size ranged from 1,631,777 to 7,990,832 for the OR population and from 746,217 to 3,756,711 for the NORA population.

RESULTS National Anesthesia Clinical Outcomes Registry Of the 12,252,846 cases currently recorded in the registry, OR anesthetics comprised 65.48% (7,990,832) whereas NORA made up the remaining 30.31%. The remaining 4.21% of the cases were submitted without clear identification of anesthesia location and therefore were kept uncategorized. From 2010 to 2013, the percentage of OR cases has stayed relatively consistent whereas that of NORA procedures has steadily increased. Within the NORA subcategories, NORA in gastroenterology suites represented 12.24% (1,548,181), cardiology represented 1.42% (173,709), and radiology locations represented 1.45% (178,153) of all NORA procedures. The remaining NORA procedures consisted of uncategorized and mixed NORA locations, which included clinic settings and at bedside. This comprised another large percentage of NORA cases at 15.2%. Non-OR anesthesia gastroenterology procedures showed the highest rate of increase between 2010 and 2013 compared with OR and other NORA subcategories, as shown in Figure 1. Given the large sample sizes of the NORA stratifications by location as gastroenterology, cardiology, or radiology suites, even small proportional differences between the NORA locations were highly significant (P < 0.0001) by χ2 analysis.

Sex The distribution of cases based on sex was similar in OR versus NORA. Female patients consisted of 54.58% of the OR population and 52.22% of the NORA population. A total of 42.77% of the OR population was male versus 41.73% of the NORA population. Sex was not identified in 2.65% of the cases in OR and 6.05% of the cases in NORA.

Age Group Comparatively, NORA procedures were performed on a higher percentage of patients who were older than 50 years (Table 1). Patients between 50 and 64 years old comprised 25.99% of all patients in the OR, compared with 29.88% of all patients in NORA. Patients who were 65 to 79 years old were anesthetized 22.13% of the time in the OR and 24.11% of the time in NORA. Patients older than 80 years consisted of 7.44% of the OR population compared with 7.93% of the NORA population. Overall, 55.56% of patients in the OR were 50 years or older, compared with 61.92% of patients in the NORA setting. Within NORA, gastroenterology and cardiology locations served a higher percentage of elderly patients older than 50 years compared with other NORA locations and in comparison with the OR. A total of 70.64% of gastroenterology patients and 79.06% of

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Complications of Non–Operating Room Procedures

FIGURE 1. Increasing number of NORA gastroenterology cases over time.

patients in the cardiology suite were older than 50 years (Table 2). Only 40.92% of radiology patients were older than 50 years. However, a greater percentage of radiology patients were younger than 1 year. Cardiology suites had a significantly greater population of patients older than 80 years compared with all other procedural locations (17.15%). Given the large sample sizes of NORA and OR, even small proportional differences between NORA and OR stratifications by age were highly significant (P < 0.0001) by χ2 analysis. Therefore, a risk analysis was performed for every level of stratification. In the unknown age group, the RR was 2.4685 with a narrow CI (2.4514–2.4858), indicating that NORA had 2.5 times the burden of the unknown age group than OR did.

these locations. American Society of Anesthesiologists status was not identified in 12.5% of cases in the OR and 17.48% of cases in NORA. However, as mentioned above, relative risk analysis did not find a proportional difference between ASA status of OR versus NORA patients. A higher percentage of NORA patients in the gastroenterology suite were ASA III (28.54%) compared with the OR (24.05%), as shown in Table 2. A total of 45.42% of cardiology patients were ASA III and 20.89% were ASA IV compared with 24.05% and 4.67%, respectively, in the OR population. A total of 30.83% of the radiology patients were ASA III and 7.75% were ASA IV. Similarly, radiology patients had higher ASA III and IV PS compared with the main OR (30.81% and 7.75%, respectively).

ASA Physical Status

Anesthesia Type

Because the RRs for escalating ASA PS hovered near 1.0 with narrow CIs, there were no proportional differences in the ASA PS classes of patients anesthetized in NORA versus OR (Table 1). The OR population had a higher percentage of ASA I to II patients, 58.64% versus 51.58% for NORA. Relative percentages of ASA III, IV, and V patients were comparable between

General anesthesia, neuraxial, and regional anesthesia made up a higher percentage of anesthetics in the OR population compared with NORA locations (65.18, 1.87%, 1.84% respectively), as shown in Table 1. Monitored anesthesia care (20.15% versus 10.89% in the OR) and sedation (2.05% versus 0.57% in the OR) were more common in NORA locations compared with the

TABLE 1. Age Group, ASA PS, and Types of Anesthesia Comparisons, OR Versus NORA Age Groups, y

Complications of Non-Operating Room Procedures: Outcomes From the National Anesthesia Clinical Outcomes Registry.

This study examines the impact of procedural locations and types of anesthetics on patient outcomes in non-operating room anesthesia (NORA) locations...
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