- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03231345
Ultrasound-guided Peripheral IJ Study
Ultrasound-guided Placement of Peripheral Intravenous Lines in the Internal Jugular Vein.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Intravenous access in the emergency department (ED) patient is essential for medication delivery, IV fluid resuscitation, rapid serum laboratory diagnostics, and administration of IV contrast for CT scans. Some patients, such as those with obesity, IV drug abuse, chronic illnesses, or vascular pathology may have difficult IV access. These patients are problematic for the busy ED nurse and physician as this can lead to a time consuming process, which slows efficiency and patient care.
Previously, patients with difficult IV access often required central venous catheterization, a procedure that can result in a number of serious complications (1). More recently, ultrasound guidance has been touted as an effective means to achieve peripheral IV access on these patients (2). In one study (2), there was a 73% first attempt cannulation rate, which seems respectable, but not excellent. Additionally, 8% of the successful IVs failed within one hour (2). Another study compared ultrasonographically guided peripheral IVs to non-ultrasonographically guided IVs, and it found that using ultrasound did not decrease the amount of time or the number of attempts it took to successfully place a peripheral IV (3). Although ultrasound-guided peripheral IV's have a role, there remains room for improvement in being able to achieve rapid IV access in those patients who need IV access on an urgent basis.
It seems that we still have room to improve our ability to obtain difficult IV access, and a relatively new technique may be the answer. Ultrasound guided IVs are typically attempted in the upper extremities, targeting the brachial or basilic veins, but a recently described technique --- the "peripheral IJ" --- involves placement of a peripheral IV catheter in the internal jugular vein (4,5).
The peripheral IJ is gaining popularity in the investigators' ED as a solution to the difficult vascular access patient. In the investigators' clinical experience, it is a quick and easy procedure that is also safe, tolerated well by patients, and requires few resources. Several small studies have concluded that this is a fast and safe procedure and a feasible alternative to central access in the difficult vascular access patient (4-7). These studies mention the theoretical risks as being similar to central venous access such as carotid artery puncture, hematoma, pneumothorax, and line infection, however none of these have actually been reported (4-7). Therefore, we seek primarily to determine the average number of attempts to cannulation for ultrasound-guided peripheral IJ placement. Secondarily, we wish to determine: 1) the prevalence of potential complications related to this procedure 2) the average time it takes the emergency physician to complete the procedure 3) the patient's satisfaction with the procedure. We will compare the data from this study to the published data for other types of ultrasound-guided peripheral IVs.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Nevada
-
Las Vegas, Nevada, Estados Unidos, 89102
- University Medical Center of Southen Nevada
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- At least 2 unsuccessful attempts at peripheral IV access by ED nursing
- Age 18 or older
Exclusion Criteria:
- Critically ill patients with clinical indications for emergent central venous access.
- Overlying skin infection
- External jugular vein easily visible for cannulation
- Patient in law enforcement custody
- Patient who is known to be pregnant or self identifies as pregnant
- Patient lacking decision making capacity
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: US guided IJ
A physician placed ultrasound-guided IV in the internal jugular vein
|
IV catheter placement
Otros nombres:
Ultrasound-guided Internal Jugular vein
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Number of Participants With Successful Cannulation of the Internal Jugular Vein
Periodo de tiempo: Less than 20 minutes
|
The primary study endpoint is successful cannulation vs failure to cannulate the internal jugular vein.
|
Less than 20 minutes
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Prevalence of Complications Related to Cannulation of the Internal Jugular Vein.
Periodo de tiempo: 24 hours
|
Percentage of Participants with successfully placed lines with a complication
|
24 hours
|
|
The Median Time Required for Cannulation of the Internal Jugular Vein by an Emergency Physician.
Periodo de tiempo: Less than 20 minutes
|
The median time it took an Emergency Physician from needle puncture to cannulation in minutes
|
Less than 20 minutes
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Joseph A Zitek, MD, UMCSN
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
- Teismann NA, Knight RS, Rehrer M, Shah S, Nagdev A, Stone M. The ultrasound-guided "peripheral IJ": internal jugular vein catheterization using a standard intravenous catheter. J Emerg Med. 2013 Jan;44(1):150-4. doi: 10.1016/j.jemermed.2012.02.044. Epub 2012 May 11.
- Stein J, George B, River G, Hebig A, McDermott D. Ultrasonographically guided peripheral intravenous cannulation in emergency department patients with difficult intravenous access: a randomized trial. Ann Emerg Med. 2009 Jul;54(1):33-40. doi: 10.1016/j.annemergmed.2008.07.048. Epub 2008 Sep 27.
- Kornbau C, Lee KC, Hughes GD, Firstenberg MS. Central line complications. Int J Crit Illn Inj Sci. 2015 Jul-Sep;5(3):170-8. doi: 10.4103/2229-5151.164940.
- Butterfield M, Abdelghani R, Mohamad M, Limsuwat C, Kheir F. Using Ultrasound-Guided Peripheral Catheterization of the Internal Jugular Vein in Patients With Difficult Peripheral Access. Am J Ther. 2017 Nov/Dec;24(6):e667-e669. doi: 10.1097/MJT.0000000000000357.
- Kiefer D, Keller SM, Weekes A. Prospective evaluation of ultrasound-guided short catheter placement in internal jugular veins of difficult venous access patients. Am J Emerg Med. 2016 Mar;34(3):578-81. doi: 10.1016/j.ajem.2015.11.069. Epub 2015 Dec 4.
- Zwank MD. Ultrasound-guided catheter-over-needle internal jugular vein catheterization. Am J Emerg Med. 2012 Feb;30(2):372-3. doi: 10.1016/j.ajem.2011.08.013. Epub 2011 Oct 26. No abstract available.
- Ash AJ, Raio C. Seldinger Technique for Placement of "Peripheral" Internal Jugular Line: Novel Approach for Emergent Vascular Access. West J Emerg Med. 2016 Jan;17(1):81-3. doi: 10.5811/westjem.2015.11.28726. Epub 2016 Jan 12.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 16.08.002
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre IV Acceso
-
Peter SzmukLuminex Corporation; Outcomes Research ConsortiumTerminado
-
Asklepios proresearchMedical University of Vienna; Q1.6 B.V.Aún no reclutando
-
Kilis 7 Aralik UniversityMersin UniversityInscripción por invitación
-
Fondazione Policlinico Universitario Agostino Gemelli...Terminado
-
Spanish Lung Cancer GroupTerminado
-
Rhaeos, Inc.ReclutamientoInfiltración intravenosa | Extravasación IVEstados Unidos
-
Maastricht Radiation OncologyAmsterdam UMC, location VUmcTerminadoCáncer en estadio IVPaíses Bajos
-
Beth Israel Medical CenterRetiradoNecesidad de acceso IVEstados Unidos
-
Jerome Canady, M.D.Activo, no reclutandoCáncer de pulmón en estadio IV | Cáncer de vejiga en estadio IV | Cáncer de páncreas en estadio IV | Neoplasia sólida maligna recurrente | Cáncer de mama en estadio IV | Cáncer de células renales en estadio IV | Cáncer de próstata en estadio IV | Cáncer de colon en estadio IV | Cáncer de recto en estadio... y otras condicionesEstados Unidos
-
Cairo UniversityReclutamiento
Ensayos clínicos sobre US guided IJ
-
Vanderbilt University Medical CenterTerminadoUltrasonografía | Cuidado crítico | Cateterismo Venoso CentralEstados Unidos
-
HealthPartners InstituteTerminadoAcceso intravenoso difícilEstados Unidos
-
Yonsei UniversityAún no reclutandoFibrilación auricularCorea del Sur
-
Rabin Medical CenterDesconocidoBiopsia de próstataIsrael
-
University Hospital Inselspital, BerneTerminadoTrombosis venosa | Síndrome PostrombóticoSuiza
-
Seno Medical Instruments Inc.Terminado
-
Clear Guide MedicalJohns Hopkins UniversityRetiradoBiopsia Hepática o Ablación
-
Cairo UniversityInscripción por invitaciónPlano transverso del abdomenEgipto
-
Azienda Ospedaliero Universitaria Maggiore della...TerminadoHipóxica aguda - Insuficiencia respiratoria hipercápnica (ARF)Italia
-
Seoul National UniversitySMG-SNU Boramae Medical CenterTerminadoSíndromes de dolor regional complejo | Dolor neuropático | Dolor del miembro fantasma | Neuralgia postherpética | Neuralgia postraumática | Dolor Post Quirúrgico CrónicoCorea, república de