Medical Devices; Anesthesiology Devices; Classification of the Positive Airway Pressure Delivery System. Final order.

The Food and Drug Administration (FDA or we) is classifying the positive airway pressure delivery system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the positive airway pressure delivery system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

Medical Devices; Anesthesiology Devices; Classification of the External Negative Pressure Airway Aid. Final order.

The Food and Drug Administration (FDA or we) is classifying the external negative pressure airway aid into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the external negative pressure airway aid's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

Evaluation of American Society of Anesthesiologists classification as 30-day morbidity predictor after single-level elective anterior cervical discectomy and fusion.

BACKGROUND CONTEXT: Higher American Society of Anesthesiologists (ASA) classification is a known predictor of postoperative complication in diverse surgical settings. However, its predictive value is not established in single-level elective anterior cervical discectomy and fusion (SLE-ACDF). PURPOSE: This study aimed to evaluate the predictive value of ASA classification system on 30-day morbidity following SLE-ACDF. DESIGN/SETTING: Patients who underwent SLE-ACDF between 2011 and 2013 were selected from the American College of Surgeons National Surgical Quality Improvement Program database. PATIENT SAMPLE: A total of 6,148 patients were selected from the 2011-2013 American College of Surgeons National Surgical Quality Improvement Program database. OUTCOME MEASURES: All outcomes are self-report measures as tracked by dedicated clinical reviewers via prospective review of inpatient charts, outpatient clinic visits, and direct contact with the surgical team. METHODS: Propensity score matching and multiple logistic regression analyses were performed to evaluate ASA classification as 30-day morbidity predictor. This study has no financial conflict and has no potential conflict of interest to disclose. RESULTS: A total of 6,148 patients were analyzed in this study. Patients in the ASA >II cohort had higher incidence of comorbidities and postoperative complications (overall complication, pneumonia, unplanned intubation, ventilator dependent >48 hours, cerebrovascular accident or stroke, catastrophic outcome, and airway complication). Propensity score matching yielded 1,628 pairs of well-matched patients. Multivariable analyses with the propensity score matched dataset revealed the following associations between ASA class >II and 30-day outcomes: any complication (odds ratio [OR] 0.82, 95% confidence interval [CI] 0.48-1.41), pneumonia (OR 1.22, 95% CI 0.33-4.56), unplanned intubation (OR 1.49, 95% CI 0.41-5.36), ventilator >48 hours (OR 5.92, 95% CI 0.69-50.96), catastrophic outcome (OR 1.02, 95% CI 0.39-2.71), and airway complication (OR 2.21, 95% CI 0.67-7.29). CONCLUSIONS: Although we did not detect associations between ASA class >II and adverse 30-day outcomes following SLE-ACDF, imprecision of estimates precludes definitive inferences. Although ASA classification allows simple assessment of patients' physiological status, their overall perioperativerisk factors need to be considered collectively for adequate optimization and improved outcomes in SLE-ACDF.

Real-time ultrasound detection of correct intravenous placement of central venous catheters after ultrasound cannulation / Comprobación ecográfica en tiempo real de la colocación intravenosa de catéteres venosos centrales tras canulación ecoguiada

No disponible

Recomendaciones de pruebas preoperatorias en el paciente adulto para procedimientos en régimen de cirugía ambulatoria / Preoperative tests recommendations in adult patients for ambulatory surgery

Tradicionalmente, la valoración anestésica ha incluido una serie de pruebas de laboratorio con la intención de detectar patologías no diagnosticadas y garantizar que el paciente concurre a la cirugía bajo unos criterios de seguridad. Estas pruebas sin una indicación clínica específica suponen un gasto innecesario, de cuestionable valor diagnóstico y son en general inútiles. En el contexto de la cirugía sin ingreso, recientes evidencias sugieren que los pacientes de cualquier edad y sin comorbilidad importante, estado físico ASA I y II, no necesitan pruebas preoperatorias complementarias de forma rutinaria. El objetivo de estas recomendaciones es determinar las indicaciones generales de las pruebas a realizar antes de la cirugía en el paciente adulto ASA I y II que se va a intervenir en cirugía ambulatoria (AU)

Anesthetic assessment traditionally included a series of laboratory tests intended to detect undiagnosed diseases, and to ensure that the patient undergoes surgery following safety criteria. These tests, without a specific clinical indication, are expensive, of questionable diagnostic value and often useless. In the context of outpatient surgery, recent evidence suggests that patients of any age without significant comorbidity, ASA physical status grade i and grade ii, do not need additional preoperative tests routinely. The aim of the present recommendations is to determine the general indications in which these tests should be performed in ASA grade i and grade ii patients undergoing ambulatory surgery (AU)

A meta-analysis of the predictive accuracy of postoperative mortality using the American Society of Anesthesiologists' physical status classification system.

BACKGROUND: The American Society of Anesthesiologists' physical status (ASA) tool has been applied to determine compensation, risk adjustment and risk prediction, but little is known about the accuracy and generalizability of this tool for prediction of postoperative mortality. METHODS: We systematically investigated prior published reports of associations between ASA physical status and mortality to test the hypothesis that ASA physical status will have varying accuracy in prediction of postoperative mortality across surgical populations with varying surgical risk of mortality. We used random effects models and metaregression to account for heterogeneity. RESULTS: Combining 77 studies with 165,705 patients, the ASA physical status tool demonstrated the following pooled performance (95 % confidence intervals)--sensitivity 0.74 (0.73, 0.74), specificity 0.67 (0.67, 0.67), and area under summary receiver operating curve 0.736 (0.725, 0.747). Metaregression revealed that study death rates and surgical specialty were significant factors. CONCLUSION: ASA physical status is a better predictor of postoperative mortality in settings with lower rather than higher death rates.

Reflejos cardiopulmonares. Implicación en anestesiología / Clinical relevance of cardiopulmonary reflexes in anesthesiology

Los barorreflejos, los reflejos mediados por quimiorreceptores, los reflejos mediados por estimulación pulmonar, el reflejo de Bezold-Jarish, el reflejo de Bainbridge y la interacción de estos con mecanismos de regulación locales son una demostración de la riqueza en las respuestas cardiovasculares que rigen en los seres humanos. Junto a ellos, el anestesiólogo debe a su vez afrontar muchas otras variables que los acentúan o modifican, como los fármacos anestésicos, la manipulación quirúrgica, la posición en la que se realiza la cirugía y la medicación que consume el paciente, que entran en juego para alterar el control cardiovascular. En el presente artículo procedemos a describir cada uno de los reflejos cardiopulmonares, sus interacciones e implicación en la anestesiología(AU)

Congreso de la Sociedad Europea de Anestesiología (European Society of anaesthesia). Referencia de la participación de los anestesiólogos españoles y de las conclusiones más importantes del congreso / No disponible

No disponible

[Training of anesthesiologists in Germany].

A structured and well-organized postgraduate professional education in medical doctors is an important and necessary component in health care these days. It is the foundation for a high quality and safety of physicians' daily work. The article describes the anesthesiological educational program, which is required to finish anesthesia residency in Germany successfully.

[How to judge a good anaesthesia from a bad one - a critical review of recovery scores and other techniques to assess the result quality of anaesthesia procedures]. / Kann man messen, wie gut eine Narkose ist? - Ein kritischer Uberblick über Recovery-Scores und andere Verfahren zur Beurteilung der Ergebnisqualität.

Patients, general public and health insurance funds focus more and more on the quality of medical performance. Anaesthesia related severe morbidity and mortality are unsuitable to judge the quality of an anaesthesia procedure. Other aspects like rapid and comfortable postoperative recovery or satisfaction of the patients with the anaesthesia procedure experience therefore rising attention. With this critical review we aim to give support for appraisal of already published studies and for design and realization of future trials.

General practitioner anaesthesia survey 2006.

A survey was posted to all general practitioner anaesthetists in Australia who are currently involved in the Joint Consultative Committee on Anaesthesia (JCCA) accreditation process known as the Maintenance of Professional Standards program (MOPS). The survey was intended to gain information regarding accreditation, continuing medical education, caseloads, on call, work practices, attitudes and future work plans. The response rate was 70% (168/240). The majority of respondents worked in a rural location (73%) where there were no specialist anaesthetists (74%). Of the respondents, 89 were category A accredited, but only 15% had this based on completion of the Advanced Rural Skills Curriculum Statement in Anaesthesia (ARSCSA) and examination. The mean number of sessions in anaesthesia worked per week was 2.8 (SD 2.2). Of the respondents, 69% administered more than 150 anaesthetics per year: 28% were on call more than 10 times per month. General surgery, gastrointestinal endoscopy, obstetrics, gynaecology and orthopaedics were the most common specialties for which anaesthesia was provided. Eight percent of respondents stated that sedation comprised 81-100% of their caseload: 92% used propofol as part of their usual intravenous sedation technique: 90% provided anaesthesia for paediatric patients with a mean minimum age of 4.1 years (SD 3.4): 64% provided epidural anaesthesia/analgesia. The majority stated that specialist anaesthetists and hospital administrations were helpful and supportive. Eighty-two percent planned to continue or increase their current anaesthetic workload over the next five years. The JCCA MOPS program appears to provide a satisfactory pathway for training, accreditation and on-going education of general practitioner anaesthetists.

An assessment of interrater reliability of the ASA physical status classification in pediatric surgical patients.

BACKGROUND: The American Society of Anesthesiologists physical status classification (ASA-PS) is used worldwide by anesthesia providers as an assessment of the preoperative physical status of patients. This assessment score has been inconsistently assigned by anesthesia providers among adult surgical patients. This study tested the reliability of assignment of ASA-PS classification among pediatric anesthesia providers. METHODS: A postal questionnaire was sent to a randomly selected sample of full members of the Society of Pediatric Anesthesiologists. Participants were asked to assign ASA-PS for 10 clinical case scenarios chosen from regular pediatric surgical cases at the investigators' institution. RESULTS: The response rate to our mailing was 54%. There was a moderate overall agreement among pediatric anesthesia providers in assigning ASA-PS for pediatric surgical patients (exact agreement 40.5-78.6%; kappa = 0.479). Exact agreement improved for combined ASA classifications of I and II (83%), and III and IV (95%). CONCLUSION: These findings suggest a moderate agreement among pediatric anesthesia providers in assigning ASA-PS classification to selected pediatric case scenarios. Most disagreement, however, represented a tendency of outside care providers to assign a higher ASA physical status for cases. Furthermore, agreement was excellent for low risk (i.e. ASA I and II) as well as high risk (ASA III and IV) cases.

Use of a modifier reduces inconsistency in the American Society of Anesthesiologists Physical Status Classification in parturients.

In this study, we sought to determine whether there is a significant discrepancy among a group of practitioners when rating pregnant patients using the ASA Physical Status Classification and whether this discrepancy could be resolved with the addition of a modifier for pregnancy. Our results indicate that significant discrepancy occurs and that it is reduced with the use of the modifier, especially when referring to the healthy parturient.