Anesthesia and analgesia
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Anesthesia and analgesia · Jun 2018
ReviewRegulatory Considerations for Physiological Closed-Loop Controlled Medical Devices Used for Automated Critical Care: Food and Drug Administration Workshop Discussion Topics.
Part of the mission of the Center for Devices and Radiological Health (CDRH) at the US Food and Drug Administration is to facilitate medical device innovation. Therefore, CDRH plays an important role in helping its stakeholders such as manufacturers, health care professionals, patients, patient advocates, academia, and other government agencies navigate the regulatory landscape for medical devices. This is particularly important for innovative physiological closed-loop controlled (PCLC) devices used in critical care environments, such as intensive care units, emergency settings, and battlefield environments. ⋯ CDRH held an open public workshop on October 13 and 14, 2015 with the aim of fostering an open discussion on design, implementation, and evaluation considerations associated with PCLC devices used in critical care environments. CDRH is currently developing regulatory recommendations and guidelines that will facilitate innovation for PCLC devices. This article highlights the contents of the white paper that was central to the workshop and focuses on the ensuing discussions regarding the engineering, clinical, and human factors considerations.
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Anesthesia and analgesia · Jun 2018
Randomized Controlled Trial Comparative StudyComparison of Intranasal Dexmedetomidine and Oral Pentobarbital Sedation for Transthoracic Echocardiography in Infants and Toddlers: A Prospective, Randomized, Double-Blind Trial.
Acquisition of transthoracic echocardiographic (TTEcho) images in children often requires sedation. The optimal sedative for TTEcho has not been determined. Children with congenital heart disease are repeatedly exposed to sedatives and anesthetics that may affect brain development. Dexmedetomidine, which in animals alters brain structure to a lesser degree, may offer advantages in this vulnerable population. ⋯ Intranasal dexmedetomidine was comparable to oral pentobarbital sedation for TTEcho sedation in infants and did not increase the risk of clinically important adverse events. Intranasal dexmedetomidine appears to be an effective "rescue" sedative for both failed pentobarbital and dexmedetomidine sedation. Dexmedetomidine could be a safer option for repeated sedation in children, but further studies are needed to assess long-term consequence of repeated sedation in this high-risk population.
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Anesthesia and analgesia · Jun 2018
ReviewAmerican Society for Enhanced Recovery: Advancing Enhanced Recovery and Perioperative Medicine.
As the population ages, the increasing surgical volume and complexity of care are expected to place additional care delivery burdens in the perioperative setting. In this age of integrated multidisciplinary care of the surgical patients, there is increasing recognition that an evidence-based perioperative pathway is associated with the optimal outcomes. ⋯ Perioperative Quality Initiatives were formed whose intent is to organize a series of consensus conferences on topics of interest related to perioperative medicine. The journal affiliation between American Society for Enhanced Recovery and Anesthesia & Analgesia will enable these evidence-based practices to be disseminated widely and swiftly to the practicing perioperative health care professionals so they can be adopted to improve the quality of perioperative surgical care.
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Anesthesia and analgesia · Jun 2018
ReviewAmerican Society for Enhanced Recovery and Perioperative Quality Initiative Joint Consensus Statement on Patient-Reported Outcomes in an Enhanced Recovery Pathway.
Patient-reported outcomes (PROs) are measures of health status that come directly from the patient. PROs are an underutilized tool in the perioperative setting. Enhanced recovery pathways (ERPs) have primarily focused on traditional measures of health care quality such as complications and hospital length of stay. ⋯ After discharge at 30 and 90 days, we recommend the use of the World Health Organization Disability Assessment Scale 2.0, or a tailored use of the Patient-Reported Outcomes Measurement Information System. (4) Future study that consistently applies PROMs in an ERP will define the role these measures will have evaluating quality and guiding clinical care. Consensus guidelines regarding the incorporation of PRO measures in an ERP were created by the POQI workgroup. The inclusion of PROMs with traditional measures of health care quality after surgery provides an opportunity to improve clinical care.
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Anesthesia and analgesia · Jun 2018
Is Compliance With Surgical Care Improvement Project Cardiac (SCIP-Card-2) Measures for Perioperative β-Blockers Associated With Reduced Incidence of Mortality and Cardiovascular-Related Critical Quality Indicators After Noncardiac Surgery?
While continuation of β-blockers (BBs) perioperatively has become a national quality improvement measure, the relationship between BB withdrawal and mortality and cardiovascular-related critical quality indicators has not been studied in a contemporary cohort of patients undergoing noncardiac surgery. ⋯ Perioperative withdrawal of BBs was associated with increased risk for mortality within 48 hours after noncardiac surgery and with decreased risk for need of vasopressor during the early postoperative period and a shorter stay in the postanesthesia care unit.