- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03252197
A Randomized Parallel Study for Simulated Internal Jugular Vein Cannulation Using Simple Needle Guide Device
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This was a prospective, randomized, parallel trial using phantom simulating internal jugular vein.
After informed consent all subjects will be randomized to insert needle for internal jugular vein cannulation of phantom using ultrasound approach with or without this device. Video camera will record all procedure process and ultrasound image in real time. Researchers blinded to the study aim measured outcome variables based on recorded images.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Seoul, Corea, república de, 03722
- Department of Emergency Medicine, Yonsei University College of Medicine, Yonsei University Severance Hospital
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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:
- Adults over 20
- Resident in clinical hospital
- Ultrasound-guided internal jugular vein insertion without supervisor experience less than 10
Exclusion Criteria:
- If they have physical problem that is difficult to perform
- If they do not want to participate in this study
- If they can not understand the contents reading the informed consent
- If they have more than 10 ultrasound guided internal jugular vein insertion without supervisor
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: New device group
participants who are tested performance for ultrasound guided cannulation using device
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Study subjects assigned to each group were trained in ultrasound guided internal jugular venous cannulation (UGIJVC) in separate spaces.
On each session, subjects were educated about UGIJVC for 30 minutes, and the instructor who was in charge of session, consisted of experienced physicians who had 50 or more UGIJVC success experiences without a supervisor in clinical field.
The instructors explained the anatomical structure and the principles of UGIJVC and then demonstrated the procedures directly to the subjects using phantom.
After that, all subjects were instructed to perform hands on practice for 30 minutes.
In case group, the instructor trained subjects using device.
On the other hand in control group, UGIVJC was demonstrated as a conventional method of approaching the target vessel while confirming the needle tip on the ultrasound screen in real time without a device.
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Comparador activo: Conventional group
participants who are tested performance for ultrasound guided cannulation using conventional method
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participants who are tested performance for ultrasound guided cannulation using conventional method.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
First attempt success
Periodo de tiempo: Within 2 minutes or after start to insertion attempt
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The first attempt success was defined as a successful attempt to perform a vein puncture in one attempt.
The number of attempts was counted each time a subject inserted a guide needle into the phantom surface, followed by withdrawal, redirect, or reinsertion.
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Within 2 minutes or after start to insertion attempt
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Posterior wall puncture of the internal jugular procedure, comfort level with procedure
Periodo de tiempo: Within 2 minutes or after start to insertion attempt
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It was defined when the needle tip on the recorded ultrasound screen was confirmed to pass through the posterior wall measurement unit : Yes or no (categorical variable)
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Within 2 minutes or after start to insertion attempt
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Carotid artery puncture
Periodo de tiempo: Within 2 minutes or after start to insertion attempt
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It was defined as the needle tip passing through the carotid lumen or the subject regurgitating artery water during cannulation attempt. measurement unit : Yes or no (categorical variable) |
Within 2 minutes or after start to insertion attempt
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Time to cannulation
Periodo de tiempo: Within 2 minutes or after start to insertion attempt
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It was defined as the time from time out for procedure start to end point measurement unit : second
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Within 2 minutes or after start to insertion attempt
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Comfort level
Periodo de tiempo: Within 2 minutes or after start to insertion attempt
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It was defined subjective opinion about difficulty during procedure for each subject measurement unit : 100-mm visual analogue scale with 0 being the least of the difficulties and 10 being the highest.
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Within 2 minutes or after start to insertion attempt
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Colaboradores e Investigadores
Patrocinador
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
Otros números de identificación del estudio
- 1-2016-0081
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.
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