Ultrasound Guided IV Access in a Pediatric Emergency Department (USgIV)
2018년 5월 10일 업데이트: 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.
연구 개요
상태
완전한
상세 설명
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.
연구 유형
중재적
등록 (실제)
163
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Pennsylvania
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Philadelphia, Pennsylvania, 미국, 19104
- The Children's Hospital of Philadelphia
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이하 (어린이, 성인)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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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위약 비교기: 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
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Success of Initial IV Placement Attempt
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Measure the overall number of IV attempts..
기간: 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.
기간: 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.
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Joseph J Zorc, MD, MSCE, Children's Hospital of Philadelphia
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2014년 5월 1일
기본 완료 (실제)
2016년 12월 2일
연구 완료 (실제)
2017년 3월 1일
연구 등록 날짜
최초 제출
2014년 4월 24일
QC 기준을 충족하는 최초 제출
2014년 4월 28일
처음 게시됨 (추정)
2014년 4월 29일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2018년 5월 15일
QC 기준을 충족하는 마지막 업데이트 제출
2018년 5월 10일
마지막으로 확인됨
2018년 5월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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