POCUS 用于急诊科外围通路困难 - 随机对照试验
急诊室外周血管通路困难的床旁超声 - 一项随机对照试验
研究概览
详细说明
外周静脉导管插入是急诊科 (ED) 中最常进行的侵入性手术。 在一些研究中,难以进入血管的人群约占评估患者的 33%,其中大多数“盲法”方法(即触诊)无法插入导管。 超声引导通常可以提高这些患者的成功率。
提出了两种用于超声引导的基本技术,即对所选血管的横向或纵向方法(即,平面外或平面内视图,分别为“单平面”方法)。
手持超声设备的可用性正在增加急诊科的数量,因为该指南用于困难的血管通路人群。
Butterly iQ+ 设备现在能够同时显示平面外和平面内视图,即所谓的双平面视图。
这项随机对照试验的目的是测试双平面超声视觉是否能够提高训练有素的操作员在急诊室收治的困难患者中获得外周血管通路的能力。
本研究将是一项随机对照、2 组、非盲法试验,在意大利都灵大学医院 Città della Salute e della Scienza di Torino 进行。
所有已经接受过超声引导血管通路培训的医护人员(即急诊医师、住院医生、护士)在接受过专门的研究培训(2 小时)后,都将被视为有资格参加该研究。
这将是一项“真实世界”研究,每个提供者都可以自由选择他/她认为适合每个患者的设备(在长度、规格、类型方面——外周中线将包括在意大利中心)。
使用随机大小的计算机化排列块,将以 1:1 的比例随机分配入组患者,以使用“标准”超声引导方法(异位或平面内视图)或双平面进行评估查看(即 错位和平面内视图,同时)。
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Turin、意大利
- Emergency Department, Città della Salute e della Scienza di Torino Univeristy Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
描述
纳入标准:必须至少存在以下标准之一以及需要外围访问
- 慢性肾病/持续透析;
- 镰状细胞性贫血;
- 长期和/或频繁使用静脉注射 毒品;
- 血管通路困难(在第一次尝试或自我报告后);
- 以前需要多次尝试/超声引导才能获得外周血管通路。
排除标准:
- 不同意参加研究。
学习计划
研究是如何设计的?
设计细节
- 主要用途:其他
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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无干预:单平面声像图
在我们机构中,急诊科外周血管通路困难的常规护理标准。
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有源比较器:双平面声像图
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双平面 Butterfly iQ+® 超声可视化将用于帮助急诊科操作员在根据病史或当前临床情况被认为难以完成这项任务的患者群体中建立静脉外周通路。
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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每个外设 i.v. 的尝试次数访问位置
大体时间:通过学习完成,可能需要 1 年半
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获得外围设备 i.v. 所需的尝试次数。
访问将被衡量
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通过学习完成,可能需要 1 年半
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每个外围设备 i.v. 所需的时间访问位置
大体时间:通过学习完成,可能需要 1 年半
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获得外围 i.v. 所需的时间
访问将被衡量
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通过学习完成,可能需要 1 年半
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合作者和调查者
调查人员
- 首席研究员:Emanuele Pivetta, MD,PhD、Città della Salute e della Scienza di Torino University Hospital
出版物和有用的链接
一般刊物
- McGee DC, Gould MK. Preventing complications of central venous catheterization. N Engl J Med. 2003 Mar 20;348(12):1123-33. doi: 10.1056/NEJMra011883. No abstract available.
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- Kumar A, Chuan A. Ultrasound guided vascular access: efficacy and safety. Best Pract Res Clin Anaesthesiol. 2009 Sep;23(3):299-311. doi: 10.1016/j.bpa.2009.02.006.
- Oliver WC Jr, Nuttall GA, Beynen FM, Raimundo HS, Abenstein JP, Arnold JJ. The incidence of artery puncture with central venous cannulation using a modified technique for detection and prevention of arterial cannulation. J Cardiothorac Vasc Anesth. 1997 Dec;11(7):851-5. doi: 10.1016/s1053-0770(97)90119-1.
- Randolph AG, Cook DJ, Gonzales CA, Pribble CG. Ultrasound guidance for placement of central venous catheters: a meta-analysis of the literature. Crit Care Med. 1996 Dec;24(12):2053-8. doi: 10.1097/00003246-199612000-00020.
- Schummer W, Schummer C, Tuppatsch H, Fuchs J, Bloos F, Huttemann E. Ultrasound-guided central venous cannulation: is there a difference between Doppler and B-mode ultrasound? J Clin Anesth. 2006 May;18(3):167-72. doi: 10.1016/j.jclinane.2005.12.010.
- Verghese ST, McGill WA, Patel RI, Sell JE, Midgley FM, Ruttimann UE. Comparison of three techniques for internal jugular vein cannulation in infants. Paediatr Anaesth. 2000;10(5):505-11. doi: 10.1046/j.1460-9592.2000.00554.x.
- Keenan SP. Use of ultrasound to place central lines. J Crit Care. 2002 Jun;17(2):126-37. doi: 10.1053/jcrc.2002.34364.
- Leung J, Duffy M, Finckh A. Real-time ultrasonographically-guided internal jugular vein catheterization in the emergency department increases success rates and reduces complications: a randomized, prospective study. Ann Emerg Med. 2006 Nov;48(5):540-7. doi: 10.1016/j.annemergmed.2006.01.011. Epub 2006 Feb 21.
- Karakitsos D, Labropoulos N, De Groot E, Patrianakos AP, Kouraklis G, Poularas J, Samonis G, Tsoutsos DA, Konstadoulakis MM, Karabinis A. Real-time ultrasound-guided catheterisation of the internal jugular vein: a prospective comparison with the landmark technique in critical care patients. Crit Care. 2006;10(6):R162. doi: 10.1186/cc5101.
- Augoustides JG, Horak J, Ochroch AE, Vernick WJ, Gambone AJ, Weiner J, Pinchasik D, Kowalchuk D, Savino JS, Jobes DR. A randomized controlled clinical trial of real-time needle-guided ultrasound for internal jugular venous cannulation in a large university anesthesia department. J Cardiothorac Vasc Anesth. 2005 Jun;19(3):310-5. doi: 10.1053/j.jvca.2005.03.007.
- Troianos CA, Jobes DR, Ellison N. Ultrasound-guided cannulation of the internal jugular vein. A prospective, randomized study. Anesth Analg. 1991 Jun;72(6):823-6. doi: 10.1213/00000539-199106000-00020. No abstract available.
- Mallory DL, McGee WT, Shawker TH, Brenner M, Bailey KR, Evans RG, Parker MM, Farmer JC, Parillo JE. Ultrasound guidance improves the success rate of internal jugular vein cannulation. A prospective, randomized trial. Chest. 1990 Jul;98(1):157-60. doi: 10.1378/chest.98.1.157.
- Pittiruti M, Hamilton H, Biffi R, MacFie J, Pertkiewicz M; ESPEN. ESPEN Guidelines on Parenteral Nutrition: central venous catheters (access, care, diagnosis and therapy of complications). Clin Nutr. 2009 Aug;28(4):365-77. doi: 10.1016/j.clnu.2009.03.015. Epub 2009 May 21.
- Troianos CA, Hartman GS, Glas KE, Skubas NJ, Eberhardt RT, Walker JD, Reeves ST; Councils on Intraoperative Echocardiography and Vascular Ultrasound of the American Society of Echocardiography. Guidelines for performing ultrasound guided vascular cannulation: recommendations of the American Society of Echocardiography and the Society of Cardiovascular Anesthesiologists. J Am Soc Echocardiogr. 2011 Dec;24(12):1291-318. doi: 10.1016/j.echo.2011.09.021. No abstract available.
- Maecken T, Grau T. Ultrasound imaging in vascular access. Crit Care Med. 2007 May;35(5 Suppl):S178-85. doi: 10.1097/01.CCM.0000260629.86351.A5.
- Chapman GA, Johnson D, Bodenham AR. Visualisation of needle position using ultrasonography. Anaesthesia. 2006 Feb;61(2):148-58. doi: 10.1111/j.1365-2044.2005.04475.x.
- Ortega R, Song M, Hansen CJ, Barash P. Videos in clinical medicine. Ultrasound-guided internal jugular vein cannulation. N Engl J Med. 2010 Apr 22;362(16):e57. doi: 10.1056/NEJMvcm0810156. No abstract available.
- French JL, Raine-Fenning NJ, Hardman JG, Bedforth NM. Pitfalls of ultrasound guided vascular access: the use of three/four-dimensional ultrasound. Anaesthesia. 2008 Aug;63(8):806-13. doi: 10.1111/j.1365-2044.2008.05513.x. Epub 2008 Jun 28.
- Hopkins RE, Bradley M. In-vitro visualization of biopsy needles with ultrasound: a comparative study of standard and echogenic needles using an ultrasound phantom. Clin Radiol. 2001 Jun;56(6):499-502. doi: 10.1053/crad.2000.0707.
- Venkatesan K. Echo-enhanced needles for short-axis ultrasound-guided vascular access. Int J Emerg Med. 2010 Apr 10;3(3):205. doi: 10.1007/s12245-010-0164-1. No abstract available.
- Reynolds N, McCulloch AS, Pennington CR, MacFadyen RJ. Assessment of distal tip position of long-term central venous feeding catheters using transesophageal echocardiology. JPEN J Parenter Enteral Nutr. 2001 Jan-Feb;25(1):39-41. doi: 10.1177/014860710102500139.
- Hsu JH, Wang CK, Chu KS, Cheng KI, Chuang HY, Jaw TS, Wu JR. Comparison of radiographic landmarks and the echocardiographic SVC/RA junction in the positioning of long-term central venous catheters. Acta Anaesthesiol Scand. 2006 Jul;50(6):731-5. doi: 10.1111/j.1399-6576.2006.01025.x.
- Leyvi G, Taylor DG, Reith E, Wasnick JD. Utility of ultrasound-guided central venous cannulation in pediatric surgical patients: a clinical series. Paediatr Anaesth. 2005 Nov;15(11):953-8. doi: 10.1111/j.1460-9592.2005.01609.x.
- Lamperti M, Caldiroli D, Cortellazzi P, Vailati D, Pedicelli A, Tosi F, Piastra M, Pietrini D. Safety and efficacy of ultrasound assistance during internal jugular vein cannulation in neurosurgical infants. Intensive Care Med. 2008 Nov;34(11):2100-5. doi: 10.1007/s00134-008-1210-9. Epub 2008 Jul 11.
- Abboud PA, Kendall JL. Ultrasound guidance for vascular access. Emerg Med Clin North Am. 2004 Aug;22(3):749-73. doi: 10.1016/j.emc.2004.04.003.
- Stone MB, Moon C, Sutijono D, Blaivas M. Needle tip visualization during ultrasound-guided vascular access: short-axis vs long-axis approach. Am J Emerg Med. 2010 Mar;28(3):343-7. doi: 10.1016/j.ajem.2008.11.022. Epub 2010 Jan 28.
- Nichols I, Humphrey JP. The efficacy of upper arm placement of peripherally inserted central catheters using bedside ultrasound and microintroducer technique. J Infus Nurs. 2008 May-Jun;31(3):165-76. doi: 10.1097/01.NAN.0000317703.66395.b8.
- Calvert N, Hind D, McWilliams R, Davidson A, Beverley CA, Thomas SM. Ultrasound for central venous cannulation: economic evaluation of cost-effectiveness. Anaesthesia. 2004 Nov;59(11):1116-20. doi: 10.1111/j.1365-2044.2004.03906.x.
- Convissar D, Bittner EA, Chang MG. Biplane Imaging Versus Standard Transverse Single-Plane Imaging for Ultrasound-Guided Peripheral Intravenous Access: A Prospective Controlled Crossover Trial. Crit Care Explor. 2021 Oct 8;3(10):e545. doi: 10.1097/CCE.0000000000000545. eCollection 2021 Oct.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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