new devices

新设备
  • 文章类型: Journal Article
    引入新的程序和具有挑战性的既定范例需要精心设计的随机对照试验(RCT)。然而,手术中的RCT提出了独特的挑战,许多治疗方法都是针对患者的个人情况,由经验提炼,受组织因素限制。与AVF相比,动静脉移植物(AVG)的结果存在相当大的争议,但是任何差异都可能反映出不同的实践和潜在的可变性。这是必要的,因此,当考虑一种新的外科手术或设备的RCT时,新方法和比较器都定义了质量保证(QA)。本系统评价的目的是使用多国,多学科方法,并提出未来RCT的方法。
    此方法先前已注册(PROSPERO:CRD420234284280)并已发布。总之,进行了四阶段审查:AVG的RCT鉴定,初步审查,质量保证方法的多学科评估与和解。在四个领域寻求质量保证措施-一般,认证,标准化和监测,数据由多国抽象,多专业审查机构。
    涉及所有四个领域的AVG的RCT中的QA是高度可变的,通常描述得欠佳,在过去的三十年里没有改善。很少有RCT建立或定义了RCT前的经验水平,没有人记录预审教育计划,或者有最低的围手术期管理标准,没有研究有明确的审前监测方案,没有人评估技术性能。
    RCT中的QA是一个相对较新的领域,正在扩大以确保证据的可靠性和可重复性。这篇综述表明,质量保证以前没有详细说明,但可以在血管通路的手术RCT中测量,并且四域方法可以很容易地在未来的RCT中实现。
    UNASSIGNED: Introducing new procedures and challenging established paradigms requires well-designed randomised controlled trials (RCT). However, RCT in surgery present unique challenges with much of treatment tailored to the individual patient circumstances, refined by experience and limited by organisational factors. There has been considerable debate over the outcomes of arteriovenous grafts (AVG) compared to AVF, but any differences may reflect differing practice and potential variability. It is essential, therefore, when considering an RCT of a novel surgical procedure or device that quality assurance (QA) is defined for both the new approach and the comparator. The aim of this systematic review was to evaluate the QA standards performed in RCT of AVG using a multi-national, multi-disciplinary approach and propose an approach for future RCT.
    UNASSIGNED: The methods of this have been previously registered (PROSPERO: CRD420234284280) and published. In summary, a four-stage review was performed: identification of RCT of AVG, initial review, multidisciplinary appraisal of QA methods and reconciliation. QA measures were sought in four areas - generic, credentialing, standardisation and monitoring, with data abstracted by a multi-national, multi-speciality review body.
    UNASSIGNED: QA in RCT involving AVG in all four domains is highly variable, often sub-optimally described and has not improved over the past three decades. Few RCT established or defined a pre-RCT level of experience, none documented a pre-trial education programme, or had minimal standards of peri-operative management, no study had a defined pre-trial monitoring programme, and none assessed technical performance.
    UNASSIGNED: QA in RCT is a relatively new area that is expanding to ensure evidence is reliable and reproducible. This review demonstrates that QA has not previously been detailed, but can be measured in surgical RCT of vascular access, and that a four-domain approach can easily be implemented into future RCT.
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  • 文章类型: Journal Article
    审查食品药品监督管理局(FDA)于2022年批准的与耳鼻喉科相关的新药和设备。
    FDA关于2022年批准的药物和设备的公开数据。
    进行初步筛查以确定与耳鼻喉科相关的药物和器械。美国耳鼻咽喉头颈外科学会(AAO-HNS)医疗器械和药物委员会成员的二次审查区分了次要更新和新批准。药物和设备的最终清单已发送给每个子专业的成员进行审查和分析。
    在初步筛选中总共鉴定出1251种设备和37种药物。其中,329个设备和5种药物被送往专家进一步审查,从中选择了37种设备和2种新药进行进一步分析。新批准的设备涵盖耳鼻喉科的所有亚专科。许多新批准的设备旨在增强患者体验,包括非处方助听器,睡眠监测设备,和精致的CPAP设备。其他旨在改善手术入路的进展,便利性,或舒适的手术室和诊所。
    每年都会批准许多新的设备和药物,以改善患者护理和护理服务。通过跟上这些进步,耳鼻喉科医师可以利用新的创新来提高护理的安全性和质量。鉴于这些设备最近的批准,需要进一步的研究来评估耳鼻咽喉科领域的长期影响.
    UNASSIGNED: To review new drugs and devices relevant to otolaryngology approved by the Food and Drug Administration (FDA) in 2022.
    UNASSIGNED: Publicly available FDA data on drugs and devices approved in 2022.
    UNASSIGNED: A preliminary screen was conducted to identify drugs and devices relevant to otolaryngology. A secondary screen by members of the American Academy of Otolaryngology-Head and Neck Surgery\'s (AAO-HNS) Medical Devices and Drugs Committee differentiated between minor updates and new approvals. The final list of drugs and devices was sent to members of each subspecialty for review and analysis.
    UNASSIGNED: A total of 1251 devices and 37 drugs were identified on preliminary screening. Of these, 329 devices and 5 drugs were sent to subspecialists for further review, from which 37 devices and 2 novel drugs were selected for further analysis. The newly approved devices spanned all subspecialties within otolaryngology. Many of the newly approved devices aimed to enhance patient experience, including over-the-counter hearing aids, sleep monitoring devices, and refined CPAP devices. Other advances aimed to improve surgical access, convenience, or comfort in the operating room and clinic.
    UNASSIGNED: Many new devices and drugs are approved each year to improve patient care and care delivery. By staying up to date with these advances, otolaryngologists can leverage new innovations to improve the safety and quality of care. Given the recent approval of these devices, further studies are needed to assess long-term impact within the field of otolaryngology.
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  • 文章类型: Journal Article
    对比剂诱发的肾病(CIN)的发生与对比剂给药量有关。使用从冠状窦(CS)去除造影剂的装置,在到达肾脏之前从体循环去除造影剂可能是有益的。本手稿旨在回顾有关在冠状动脉造影或干预期间从CS中去除造影剂以预防CIN的现有文献。
    The occurrence of contrast-induced-nephropathy (CIN) is related to the amount of contrast administration. Any removal of contrast from systemic circulation before reaching the kidneys might be beneficial using a device that removes contrast from a coronary sinus (CS). This manuscript aims to review the available literature regarding contrast removal from CS during coronary angiography or intervention for the prevention of CIN.
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  • 文章类型: Journal Article
    UNASSIGNED: Long peripheral catheters are peripheral intravenous catheters of 6-15 cm in length. They are commonly inserted into the forearm, antecubital fossa or upper arm using a direct Seldinger technique. They have proven to be valuable for peripheral intravenous catheters, particularly in patients with difficult intravenous access.
    UNASSIGNED: We conducted a systematic review of studies reporting the use of long peripheral catheters. The following keywords were used: \'long\', \'Seldinger\', \'guidewire\', \'peripheral\', \'venous\', \'intravenous\', \'IV\', \'vascular\', \'cannula\' and \'catheter\'.
    UNASSIGNED: Three hundred forty-one publications were identified; 16 were included in the systematic review. There were 11 adult studies and 5 paediatric studies documenting 1288 long peripheral catheters in 1271 patients. Majority of studies (12/16) were conducted in acute care settings, (emergency department, n = 6; intensive care unit, n = 3; high dependency unit, n = 1; surgical unit, n = 2). The most frequently studied long peripheral catheter was 8 cm in length and 20 G in size. Nine studies recruited patients with difficult intravenous access; 11 studies used ultrasound guidance. Insertion success rate and mean procedural time ranged between 86% and 100% and 8 and 16.8 minutes, respectively. Average catheter duration ranged between 4 and 14.7 days (mean) and 1.1 and 9 days (median). Catheter failure occurred in 4.3-52.5% of long peripheral catheters, with leakage, infiltration and dislodgement being the most frequent causes of failure. In 3 randomised controlled trials, long peripheral catheters outperformed peripheral intravenous catheters in terms of duration and failure rate.
    UNASSIGNED: Long peripheral catheters are safe and reliable in both adults and children. In addition, long peripheral catheters may provide improved quality of care over peripheral intravenous catheters for multi-day intravenous therapy.
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