Effect of Three Side Hole Infusion Catheter on CT Image Quality Compared to a Standard Infusion Catheter
3 de mayo de 2018 actualizado por: Joseph P Hasapes, The University of Texas Health Science Center, Houston
IV Contrast Administration: Effect of Three Side Hole Infusion Catheter on CT Image Quality, Infusion Pressure, and Infusion Rates, Compared to a Standard Infusion Catheter
The purpose of this research study is to compare two types of catheters used for infusing the contrast dye necessary for viewing internal organs during computed tomography (CT) scanning.
The standard catheter, which has one hole from which contrast dye enters veins, will be compared to the Becton Dickinson Nexiva Diffusics System catheter, which has three holes for diffusing dye into veins.
The purpose of this study is to determine which catheter type gives the best image.
Descripción general del estudio
Estado
Terminado
Intervención / Tratamiento
Descripción detallada
This will be a prospective, randomized, controlled trial.
The catheter is already in use at our facilities.
After informed consent, patients will be randomly given the standard or new catheter in our practice.
Envelopes with the random assignment will be available to the individuals consenting patients.
Randomization generally ensures that study groups are similar on average.
As age, sex, and weight impact image quality, we will collect data on these factors in case randomization results in an imbalance.
This will allow for control of these factors in analysis of the data.
Data will be collected from CT abdomen pelvis examinations within a 6 month-1 year period in 2016 - 2017.
Our primary outcome is image quality, measured as tissue density and distribution of contrast within the liver, spleen, aorta and IVC.
Our secondary outcomes include Peak Contrast Infusion Pressure and Injection Flow Rate.
Possible adverse events for use of any type of catheter include contrast infiltration into the subcutaneous tissues which is a minor limited event.
All infiltrations will be recorded as part of the permanent medical record, documented in the chart, and the referring physician notified.
The patient will be assessed by a physician immediately and referred to the ED if necessary for further evaluation.
Current technology utilizes Power injector equipment which alerts the technologist to the pressure being achieved.
If the injection pressure exceeds 325 psi the Power injector automatically shuts off.
Tipo de estudio
Intervencionista
Inscripción (Actual)
61
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Texas
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Houston, Texas, Estados Unidos, 77030
- The University of Texas Health Science Center at Houston
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Patients undergoing contrast enhanced CT abdomen pelvis examinations at Lyndon B. Johnson General Hospital in Texas
- Patients whose access point is the antecubital fossa
- Patients receiving 20 or 22 gauge catheters for their CT exam
- Patients scanned on two 64 slice CT scanners at the same hospital
Exclusion Criteria:
- patients whose access point is other than antecubital fossa
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Diagnóstico
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Becton Dickinson Nexiva Diffusics System
Intervention with the new Becton Dickinson Nexiva Diffusics System will be evaluated to see if it will improve image quality compared to the standard catheter.
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Becton Dickinson Nexiva Diffusics System will be used to inject IV contrast and will be compared to a single hole catheter to see if it improves image quality in the main vessels in the abdomen and pelvis because of its novel design.
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Comparador activo: Standard intravenous catheter
Standard catheter with one hole at the tip will be compared to novel 3 hole Becton Dickinson Nexiva Diffusics System to see which catheter provides the best image quality.
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Standard catheter with one hole at the tip will be compared to a novel 3 hole catheter to see which catheter provides the best image quality.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Image Quality as Assessed by Ratio of Tissue Density of Main Portal Vein (MPV) to the Aorta
Periodo de tiempo: at the time of CT scanning
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The ratio of tissue density measured in the main portal vein (MPV) to tissue density in the aorta on the CT images will be determined and will provide a measure of biodistribution, which is an important indicator of image quality.
Dividing each Hounsfield unit measurement by the aorta density and determining these ratios will be done on a per patient basis to assess biodistribution as a measure of image quality.
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at the time of CT scanning
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Image Quality as Assessed by Ratio of Tissue Density of Spleen to the Aorta
Periodo de tiempo: at the time of CT scanning
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The ratio of tissue density measured in the spleen to tissue density in the aorta on the CT images will be determined and will provide a measure of biodistribution, which is an important indicator of image quality.
Dividing each Hounsfield unit measurement by the aorta density and determining these ratios will be done on a per patient basis to assess biodistribution as a measure of image quality.
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at the time of CT scanning
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Image Quality as Assessed by Ratio of Tissue Density of Inferior Vena Cava (IVC) to the Aorta
Periodo de tiempo: at the time of CT scanning
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The ratio of tissue density measured in the inferior vena cava (IVC) to tissue density in the aorta on the CT images will be determined and will provide a measure of biodistribution, which is an important indicator of image quality.
Dividing each Hounsfield unit measurement by the aorta density and determining these ratios will be done on a per patient basis to assess biodistribution as a measure of image quality.
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at the time of CT scanning
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Image Quality as Assessed by Rating Scale
Periodo de tiempo: at the time of CT scanning
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Radiologists blinded to catheter type will review images and rate them on a scale of 1 to 10. 10 indicates a better outcome.
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at the time of CT scanning
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Peak Contrast Infusion Pressure
Periodo de tiempo: at the time of CT scanning
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The peak contrast infusion pressure is recorded in the electronic health record (EHR) during every CT examination preformed at the hospitals taking part in this study.
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at the time of CT scanning
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Injection Flow Rate
Periodo de tiempo: at the time of CT scanning
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The injection flow rate is recorded in the electronic health record (EHR) during every CT examination preformed at the hospitals taking part in this study.
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at the time of CT scanning
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Investigadores
- Investigador principal: Joseph Hasapes, MD, The University of Texas Health Science Center, Houston
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de octubre de 2016
Finalización primaria (Actual)
1 de noviembre de 2016
Finalización del estudio (Actual)
1 de noviembre de 2016
Fechas de registro del estudio
Enviado por primera vez
20 de octubre de 2016
Primero enviado que cumplió con los criterios de control de calidad
20 de octubre de 2016
Publicado por primera vez (Estimar)
24 de octubre de 2016
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
6 de junio de 2018
Última actualización enviada que cumplió con los criterios de control de calidad
3 de mayo de 2018
Última verificación
1 de mayo de 2018
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- HSC-MS15-0906
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 Becton Dickinson Nexiva Diffusics System
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University of BialystokDesconocido
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University of Lausanne HospitalsTerminadoDispositivo de vacunación intradérmica (ID)