Major Adverse Events and Relationship to Nil per Os Status in Pediatric Sedation/Anesthesia Outside the Operating Room: A Report of the Pediatric Sedation Research Consortium.

BACKGROUND: Studies that have attempted to define the incidence of aspiration or pulmonary complications during sedation/anesthesia of children with respect to nil per os (NPO) status or other factors are difficult because of the relatively infrequent rate of these complications. METHODS: The Pediatric Sedation Research Consortium consists of 42 participating institutions with elective sedation services that submit consecutive patient encounter information to a central database. The authors evaluated aspiration episodes and a combined outcome of major adverse events (defined as aspiration, death, cardiac arrest, or unplanned hospital admission) with respect to NPO status, American Society of Anesthesiologists physical status, age, propofol use, procedure types, and urgency of the procedure. RESULTS: A total of 139,142 procedural sedation/anesthesia encounters were collected between September 2, 2007 and November 9, 2011. There were 0 deaths, 10 aspirations, and 75 major complications. NPO status was known for 107,947 patients, of whom 25,401 (23.5 %) were not NPO. Aspiration occurred in 8 of 82,546 (0.97 events per 10,000) versus 2 of 25,401 (0.79 events per 10,000) patients who were NPO and not NPO, respectively (odds ratio, 0.81; 95% CI, 0.08 to 4.08; P = 0.79). Major complications occurred in 46 of 82,546 (5.57 events per 10,000) versus 15 of 25,401 (5.91 events per 10,000) (odds ratio, 1.06; 95% CI, 0.55 to 1.93; P = 0.88). Multivariate adjustment did not appreciably impact the effect of NPO status. CONCLUSIONS: The analysis suggests that aspiration is uncommon. NPO status for liquids and solids is not an independent predictor of major complications or aspiration in this sedation/anesthesia data set.

Prevalence and Predictors of Adverse Events during Procedural Sedation Anesthesia-Outside the Operating Room for Esophagogastroduodenoscopy and Colonoscopy in Children: Age Is an Independent Predictor of Outcomes.

OBJECTIVES: Procedural sedation/anesthesia outside the operating room for a variety of procedures is well described with an overall low adverse event rate in certain settings. Adverse event associated with procedural sedation/anesthesia outside the operating room for gastrointestinal procedures have been described, albeit in small, single-center studies with wide variance in outcomes. Predictors of such outcomes are unclear. We aimed to estimate the prevalence of adverse event in children undergoing procedural sedation/anesthesia outside the operating room for esophagogastroduodenoscopy, colonoscopy, or both to identify predictors of adverse event. DESIGN/SETTING/PATIENTS: Retrospective analysis of Pediatric Sedation Research Consortium database, a large data repository of pediatric patients aged 21 years old or younger undergoing procedural sedation/anesthesia outside the operating room during September 2007 to November 2011. Twenty-two of the 40 centers provided data pertaining to the procedure of interest. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Primary outcome variable is any adverse event. Independent variables include: age (five groups), sex, American Societyof Anaesthesiologists status, procedure (esophagogastroduodenoscopy, colonoscopy, or both), provider responsible, medication used, location, and presence of coexisting medical conditions. Descriptive statistics used to summarize the data. Using multivariablelogistic regression model, odds ratio, 95% CI) were computed. A total of 12,030 procedures were performed (esophagogastroduodenoscopy, 7,970; colonoscopy, 1,378; and both, 2,682). A total of 96.9% of patients received propofol. Eighty-three percent were performed in a sedation unit. Prevalence of adverse event was 4.8%. The most common adverse event were persistent desaturations (1.5%), airway obstruction (1%), cough (0.9%), and laryngospasm (0.6%). No deaths or CPR occurred. Infants and children aged 5 years old or younger had a higher adverse event rate than older children (15.8%, 7.8% vs 4%). Regression analysis revealed age 5 years old or younger, American Society of Anaesthesiologists greater than or equal to 2, esophagogastroduodenoscopy ± colonoscopy, and coexisting medical conditions of obesity and lower airway disease were independent predictors of higher adverse event. CONCLUSIONS: Overall prevalence of any adverse event was 4.8%. Independent predictors of adverse events in procedural sedation/anesthesia outside the operating room in pediatric esophagogastroduodenoscopy/colonoscopy onoscopy were identified. Recognition of such risk factors may enable optimization of procedural sedation.

The incidence and nature of adverse events during pediatric sedation/anesthesia with propofol for procedures outside the operating room: a report from the Pediatric Sedation Research Consortium.

OBJECTIVE: We used a large database of prospectively collected data on pediatric sedation/anesthesia outside the operating room provided by a wide range of pediatric specialists to delineate the nature and frequency of adverse events associated with propofol-based sedation/anesthesia care. PATIENTS AND METHODS: Data were collected by the Pediatric Sedation Research Consortium, a collaborative group of institutions dedicated to improving sedation/anesthesia care for children internationally. Members prospectively enrolled consecutive patients receiving sedation or sedation/anesthesia for procedures. The primary inclusion criterion was the need for some form of sedation/anesthesia to perform a diagnostic or therapeutic procedure outside the operating room. There were no exclusion criteria. Data on demographics, primary illness, coexisting illness, procedure performed, medications used, procedure and recovery times, medication doses outcomes of anesthesia, airway interventions and adverse events were collected and reported using web-based data collection tool. For this study, we evaluated all instances where propofol was used as the primary drug in the sedation/anesthesia technique. RESULTS: Thirty-seven locations submitted data on 49,836 propofol sedation/anesthesia encounters during the study period from July 1, 2004 until September 1, 2007. There were no deaths. Cardiopulmonary resuscitation was required twice. Aspiration during sedation/anesthesia occurred four times. Less serious events were more common with O(2) desaturation below 90% for more than 30 s, occurring 154 times per 10,000 sedation/anesthesia administrations. Central apnea or airway obstruction occurred 575 times per 10,000 sedation/anesthesia administrations. Stridor, laryngospasm, excessive secretions, and vomiting had frequencies of 50, 96, 341, and 49 per 10,000 encounters, respectively. Unexpected admissions (increases in levels of care required) occurred at a rate of 7.1 per 10,000 encounters. In an unadjusted analysis, the rate of pulmonary adverse events was not different for anesthesiologists versus other providers. CONCLUSIONS: We report the largest series of pediatric propofol sedation/anesthesia for procedures outside the operating room. The data indicate that propofol sedation/anesthesia is unlikely to yield serious adverse outcomes in a collection of institutions with highly motivated and organized sedation/anesthesia services. However, the safety of this practice is dependent on a system's ability to manage less serious events. We propose that our data suggest variables for training and credentialing providers of propofol sedation/anesthesia and the system characteristics that promote safe use of this drug.

Patient privacy: how far is too far?

With few exceptions, personal privacy has long been an ethical right and legal mandate. Clinicians, policy makers, and consumers are challenged to find a balance between allowing consumers to be protected and allowing clinicians to meet patient care needs. This article examines the current debate pertaining to new Medical Privacy Guidelines that were issued in April 2001. The ethical principle of patient confidentiality, including the right to personal privacy, is reviewed along with its relationship to computer-generated wound care tracking programs that transcend practice settings. Options for Health Insurance Portability and Accountability Act (HIPAA) compliance are presented.

Recognizing spiritual distress.

Recent research suggests that while attending worship services may extend life, spiritual distress may cut lives shorter. Although authors of this research agree that more study is needed, they recognize that elderly ill men and women who experience a religious struggle with their illnesses appear to be at risk for an earlier death, even after controlling for baseline health, mental health, and demographic factors. This article examines the patient-professional relationship within the framework of virtue ethics and spiritual distress. A case study is presented.

Incidence and nature of adverse events during pediatric sedation/anesthesia for procedures outside the operating room: report from the Pediatric Sedation Research Consortium.

OBJECTIVE: We sought to use a large database of prospectively collected data on pediatric sedation and/or anesthesia for diagnostic and therapeutic procedures to delineate the nature and the frequency of adverse events that are associated with sedation/anesthesia care for procedures that are performed outside the operating room in children. METHODS: Data were collected by the Pediatric Sedation Research Consortium, a collaborative group of 35 institutions that are dedicated to improving sedation/anesthesia care for children internationally. Members prospectively enrolled consecutive patients who were receiving sedation or anesthesia for procedures. Data on demographics, primary illness, coexisting illness, procedure performed, medications used, outcomes, airway interventions, and adverse events were collected and reported on a Web-based data collection tool. RESULTS: A total of 26 institutions submitted data on 30,037 sedation/anesthesia encounters during the study period from July 1, 2004, to November 15, 2005. Serious adverse events were rare in the institutions involved in this study; there were no deaths. Cardiopulmonary resuscitation was required once. Less serious events were more common with O2 desaturation below 90% for > 30 seconds, occurring 157 times per 10000 sedations. Stridor and laryngospasm both occurred in 4.3 per 10,000 sedations. Unexpected apnea, excessive secretions, and vomiting had frequencies of 24, 41.6, and 47.2 per 10,000 encounters, respectively. CONCLUSIONS: Our data indicate that pediatric sedation/anesthesia for procedures outside the operating room is unlikely to yield serious adverse outcomes in a collection of institutions with highly motivated and organized sedation services. However, the safety of this practice depends on the systems' ability to manage less serious events.