Ultrasound Guided IV Access in a Pediatric Emergency Department (USgIV)
2018年5月10日 更新者：Children's Hospital of Philadelphia
A Randomized Control Trial of Ultrasound Guided IV Access in the Pediatric Emergency Department
The primary objective is to determine whether the use of ultrasound guidance compared to standard IV access improves the proportion of successful IV placement on a first attempt for children in a pediatric emergency department who have predicted difficult access by a validated score.
Secondary objectives include determining whether ultrasound-guided IV access lowers the overall number of IV attempts and/or reduces time to IV access.
The investigators will also examine the duration of IV access and any complications related to IV access in both the traditional and ultrasound guided IV access group.
研究概览
地位
完全的
详细说明
The proposed study is a randomized trial of ultrasound guided IV access compared to traditional IV access in patients determined to have difficult IV access based on the Difficult Intravenous Access (DIVA) scale.
Patients enrolled in the study will be randomized to traditional IV access or ultrasound guided IV access.
If randomized to ultrasound guided IV access, the IV will be placed under direct visualization.
Following IV placement or when attempts at IV access have ceased, the patient and family will be asked to complete a series of questions related to their satisfaction regarding IV placement.
The follow-up phase examining duration of the IV and any related complications will continue until the IV placed as part of the study has been removed.
研究类型
介入性
注册 (实际的)
163
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
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Pennsylvania
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Philadelphia、Pennsylvania、美国、19104
- The Children's Hospital of Philadelphia
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
不超过 18年 (孩子、成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Emergency department patients ages 0-18 years
- Requiring IV access as determined by emergency department attending physician
- Predicted difficult IV access as defined by a revised DIVA score >3
Exclusion Criteria:
- Unstable patients triaged as a Level 1 triage acuity
- Patients who refuse IV access
- Non-English speaking parent/guardian
- No study team member available to enroll patient
- Parent/guardian does not consent
- Allergy to ultrasound gel
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 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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实验性的：Ultrasound guided intravenous access
This group will have their IV placed by ultrasound guidance.
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The ultrasound machine will be used to guide intravenous line placement in patients randomized to the ultrasound guided intravenous line group
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安慰剂比较：Traditional intravenous access
The patients randomized to traditional IV access will have their IVs placed by standard technique.
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Placement by experienced nurse using standard IV techniques
其他名称：
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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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Success of Initial IV Placement Attempt
大体时间：Participants will be followed through the duration of emergency department stay, an expected average of 4 hours
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Patients will be randomized to traditional IV placement or ultrasound guided IV placement immediately after enrollment.
The IV will be placed directly following enrollment.
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Participants will be followed through the duration of emergency department stay, an expected average of 4 hours
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Measure the overall number of IV attempts..
大体时间：Participants will be followed through the duration of emergency department stay, an expected average of 4 hours
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We will record the number of IV attempts made until a patient has a successfully placed IV or further attempts are aborted.
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Participants will be followed through the duration of emergency department stay, an expected average of 4 hours
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Time to IV access.
大体时间：Participants will be followed through the duration of emergency department stay, an expected average of 4 hours
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The time from enrollment until successful IV access is obtained will be measured.
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Participants will be followed through the duration of emergency department stay, an expected average of 4 hours
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Patient & family satisfaction with IV placement method.
大体时间：Participants will be followed through the duration of emergency department stay, an expected average of 4 hours
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A survey will be given to parents and patients over age 12 years to ask them about their experience with the IV placement.
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Participants will be followed through the duration of emergency department stay, an expected average of 4 hours
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Compare the survival (in length of time) of IV access
大体时间：Participants will be followed through the duration of hospital stay, expected average of 5 days
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We will track the IVs placed as part of the study through the electronic medical record to determine when and why they were removed and if there were any associated complications.
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Participants will be followed through the duration of hospital stay, expected average of 5 days
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Joseph J Zorc, MD, MSCE、Children's Hospital of Philadelphia
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Yen K, Riegert A, Gorelick MH. Derivation of the DIVA score: a clinical prediction rule for the identification of children with difficult intravenous access. Pediatr Emerg Care. 2008 Mar;24(3):143-7. doi: 10.1097/PEC.0b013e3181666f32.
- Fein JA, Callahan JM, Boardman CR, Gorelick MH. Predicting the need for topical anesthetic in the pediatric emergency department. Pediatrics. 1999 Aug;104(2):e19. doi: 10.1542/peds.104.2.e19.
- Frey AM. Success rates for peripheral i.v. insertion in a children's hospital. Financial implications. J Intraven Nurs. 1998 May-Jun;21(3):160-5. Erratum In: J Intraven Nurs 1998 Jul-Aug;21(4):220.
- Riker MW, Kennedy C, Winfrey BS, Yen K, Dowd MD. Validation and refinement of the difficult intravenous access score: a clinical prediction rule for identifying children with difficult intravenous access. Acad Emerg Med. 2011 Nov;18(11):1129-34. doi: 10.1111/j.1553-2712.2011.01205.x.
- Doniger SJ, Ishimine P, Fox JC, Kanegaye JT. Randomized controlled trial of ultrasound-guided peripheral intravenous catheter placement versus traditional techniques in difficult-access pediatric patients. Pediatr Emerg Care. 2009 Mar;25(3):154-9. doi: 10.1097/PEC.0b013e31819a8946.
- Keyes LE, Frazee BW, Snoey ER, Simon BC, Christy D. Ultrasound-guided brachial and basilic vein cannulation in emergency department patients with difficult intravenous access. Ann Emerg Med. 1999 Dec;34(6):711-4. doi: 10.1016/s0196-0644(99)70095-8.
- Au AK, Rotte MJ, Grzybowski RJ, Ku BS, Fields JM. Decrease in central venous catheter placement due to use of ultrasound guidance for peripheral intravenous catheters. Am J Emerg Med. 2012 Nov;30(9):1950-4. doi: 10.1016/j.ajem.2012.04.016. Epub 2012 Jul 15.
- Gregg SC, Murthi SB, Sisley AC, Stein DM, Scalea TM. Ultrasound-guided peripheral intravenous access in the intensive care unit. J Crit Care. 2010 Sep;25(3):514-9. doi: 10.1016/j.jcrc.2009.09.003. Epub 2009 Oct 15.
- Dargin JM, Rebholz CM, Lowenstein RA, Mitchell PM, Feldman JA. Ultrasonography-guided peripheral intravenous catheter survival in ED patients with difficult access. Am J Emerg Med. 2010 Jan;28(1):1-7. doi: 10.1016/j.ajem.2008.09.001.
- Benkhadra M, Collignon M, Fournel I, Oeuvrard C, Rollin P, Perrin M, Volot F, Girard C. Ultrasound guidance allows faster peripheral IV cannulation in children under 3 years of age with difficult venous access: a prospective randomized study. Paediatr Anaesth. 2012 May;22(5):449-54. doi: 10.1111/j.1460-9592.2012.03830.x. Epub 2012 Mar 12.
- Heinrichs J, Fritze Z, Vandermeer B, Klassen T, Curtis S. Ultrasonographically guided peripheral intravenous cannulation of children and adults: a systematic review and meta-analysis. Ann Emerg Med. 2013 Apr;61(4):444-454.e1. doi: 10.1016/j.annemergmed.2012.11.014. Epub 2013 Feb 15.
- Bair AE, Rose JS, Vance CW, Andrada-Brown E, Kuppermann N. Ultrasound-assisted peripheral venous access in young children: a randomized controlled trial and pilot feasibility study. West J Emerg Med. 2008 Nov;9(4):219-24.
- Aponte H, Acosta S, Rigamonti D, Sylvia B, Austin P, Samolitis T. The use of ultrasound for placement of intravenous catheters. AANA J. 2007 Jun;75(3):212-6.
- Bauman M, Braude D, Crandall C. Ultrasound-guidance vs. standard technique in difficult vascular access patients by ED technicians. Am J Emerg Med. 2009 Feb;27(2):135-40. doi: 10.1016/j.ajem.2008.02.005.
- Costantino TG, Parikh AK, Satz WA, Fojtik JP. Ultrasonography-guided peripheral intravenous access versus traditional approaches in patients with difficult intravenous access. Ann Emerg Med. 2005 Nov;46(5):456-61. doi: 10.1016/j.annemergmed.2004.12.026.
- Lininger RA. Pediatric peripheral i.v. insertion success rates. Pediatr Nurs. 2003 Sep-Oct;29(5):351-4.
- Panebianco NL, Fredette JM, Szyld D, Sagalyn EB, Pines JM, Dean AJ. What you see (sonographically) is what you get: vein and patient characteristics associated with successful ultrasound-guided peripheral intravenous placement in patients with difficult access. Acad Emerg Med. 2009 Dec;16(12):1298-1303. doi: 10.1111/j.1553-2712.2009.00520.x. Epub 2009 Nov 12.
- Schnadower D, Lin S, Perera P, Smerling A, Dayan P. A pilot study of ultrasound analysis before pediatric peripheral vein cannulation attempt. Acad Emerg Med. 2007 May;14(5):483-5. doi: 10.1197/j.aem.2006.12.016.
- Vinograd AM, Chen AE, Woodford AL, Fesnak S, Gaines S, Elci OU, Zorc JJ. Ultrasonographic Guidance to Improve First-Attempt Success in Children With Predicted Difficult Intravenous Access in the Emergency Department: A Randomized Controlled Trial. Ann Emerg Med. 2019 Jul;74(1):19-27. doi: 10.1016/j.annemergmed.2019.02.019. Epub 2019 May 22.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2014年5月1日
初级完成 (实际的)
2016年12月2日
研究完成 (实际的)
2017年3月1日
研究注册日期
首次提交
2014年4月24日
首先提交符合 QC 标准的
2014年4月28日
首次发布 (估计)
2014年4月29日
研究记录更新
最后更新发布 (实际的)
2018年5月15日
上次提交的符合 QC 标准的更新
2018年5月10日
最后验证
2018年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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