- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02360163
The "Peripheral Access Utilizing Sonographic Evaluation" Study (PAUSE)
Descripción general del estudio
Estado
Condiciones
Descripción detallada
The purpose of this study is to reduce, by using the ultrasound guided technique, the minor surgical procedures that might be required to deliver fluids into the blood of critically ill patients simply because the patients' veins cannot be located through the manual technique.
The ultrasound assisted technique will increase accessibility to small veins that might be missed via the manual technique. The technique of using an ultrasound machine to assist the administration of fluids into a patient's veins is called ultrasound guided peripheral intravenous access (USGPIVA), while the traditional technique that uses only sight and touch to locate a patient veins without machine assistance is called the traditional landmark technique (TLT). The investigators will compare the effectiveness of USGPIVA with TLT in terms of reducing complications and costs.
Tipo de estudio
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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New Jersey
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Hackensack, New Jersey, Estados Unidos, 07601
- Hackensack University Medical Center
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- The patient is >= 21 years of age
- Adult critically ill patients in CCU and MICU requiring short peripheral intravenous access
- The patient has been identified as difficult intravenous access (DIVA), defined as at least two failed blind sticks in the antecubital fossa or more distal upper arm veins
- The patient does not otherwise require a CVC
Exclusion Criteria:
The patient has a PICC line on the same side as IV placement and has the following:
- Has a condition poses risk for DIC, inadequate flow, or infection.
- Has been identified as a site for "Save the Vein" protocol implementation, unless permission is otherwise obtained by the patient's physician.
- Has a hemodialysis fistula in place on that upper arm side.
The patient is expected to require therapeutic agent or procedure that necessitates central venous access such as:
- central venous monitoring
- Total Parenteral Nutrition
- Antibiotic requiring central venous access
- Chemotherapy
- Vesicants
- Medications pH less than 5 or more than 9
- Medications of glucose concentrations above 10%
- Solution with protein concentrations above 5% (Vascular Access Management, n.d.)
- The patient already has a central venous catheter access, for reasons other than DIVA, through which therapy can be infused
- The patient has renal disease and a "Save The Vein" order is anticipated or pending (serum creatinine >2mg/dL and GFR <20) for one of the patient's arms, unless permission is otherwise obtained by the patient's physician
- The patient has a bleeding disorder, unless permission is otherwise obtained by the patient's physician
- The clinician believes the patient is not a good fit for the study or that the procedure is not appropriate for patient at the given moment
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: Landmark Technique Attempt
Patients will undergo an additonal TLT attempt
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|
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Experimental: USGPIVA Technique Attempt
Patients will be offered a USGPIVA attempt after two failed attempts using the traditional landmark technique (TLT)
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Reduction in number of minor surgical procedures that may be required to deliver fluids into the blood of critically ill patients by using the ultrasound guided technique
Periodo de tiempo: 1 Day
|
1 Day
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Nancy Van Buitenen, MSN, APN, RN, Hackensack UMC
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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 (Estimar)
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
Otros números de identificación del estudio
- Pro 2921
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. .