Ultrasound Guided IV Access in a Pediatric Emergency Department (USgIV)
10 de maio de 2018 atualizado por: 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.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Intervencional
Inscrição (Real)
163
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Estados Unidos, 19104
- The Children's Hospital of Philadelphia
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
Não mais velho que 18 anos (Filho, Adulto)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Ultrasound guided intravenous access
This group will have their IV placed by ultrasound guidance.
|
The ultrasound machine will be used to guide intravenous line placement in patients randomized to the ultrasound guided intravenous line group
|
|
Comparador de Placebo: Traditional intravenous access
The patients randomized to traditional IV access will have their IVs placed by standard technique.
|
Placement by experienced nurse using standard IV techniques
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Success of Initial IV Placement Attempt
Prazo: Participants will be followed through the duration of emergency department stay, an expected average of 4 hours
|
Patients will be randomized to traditional IV placement or ultrasound guided IV placement immediately after enrollment.
The IV will be placed directly following enrollment.
|
Participants will be followed through the duration of emergency department stay, an expected average of 4 hours
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Measure the overall number of IV attempts..
Prazo: Participants will be followed through the duration of emergency department stay, an expected average of 4 hours
|
We will record the number of IV attempts made until a patient has a successfully placed IV or further attempts are aborted.
|
Participants will be followed through the duration of emergency department stay, an expected average of 4 hours
|
|
Time to IV access.
Prazo: Participants will be followed through the duration of emergency department stay, an expected average of 4 hours
|
The time from enrollment until successful IV access is obtained will be measured.
|
Participants will be followed through the duration of emergency department stay, an expected average of 4 hours
|
|
Patient & family satisfaction with IV placement method.
Prazo: Participants will be followed through the duration of emergency department stay, an expected average of 4 hours
|
A survey will be given to parents and patients over age 12 years to ask them about their experience with the IV placement.
|
Participants will be followed through the duration of emergency department stay, an expected average of 4 hours
|
|
Compare the survival (in length of time) of IV access
Prazo: Participants will be followed through the duration of hospital stay, expected average of 5 days
|
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.
|
Participants will be followed through the duration of hospital stay, expected average of 5 days
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Joseph J Zorc, MD, MSCE, Children's Hospital of Philadelphia
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- 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.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de maio de 2014
Conclusão Primária (Real)
2 de dezembro de 2016
Conclusão do estudo (Real)
1 de março de 2017
Datas de inscrição no estudo
Enviado pela primeira vez
24 de abril de 2014
Enviado pela primeira vez que atendeu aos critérios de CQ
28 de abril de 2014
Primeira postagem (Estimativa)
29 de abril de 2014
Atualizações de registro de estudo
Última Atualização Postada (Real)
15 de maio de 2018
Última atualização enviada que atendeu aos critérios de controle de qualidade
10 de maio de 2018
Última verificação
1 de maio de 2018
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 13-010758
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .