- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04541446
Study Dynamic Haptic Robotic Trainer (DHRT) and DHRT+ for Central Venous Catheterization Insertion Training for Residents
Estudie Entrenador robótico háptico dinámico (DHRT) y DHRT+ para entrenamiento de inserción de CVC para residentes de cirugía
Human participants will include medical residents. Each year, the entering first-year medical residents at Milton S. Hershey Medical Center and Cedars-Sinai Medical Center will be taught to perform central venous catheterization using the Dynamic Haptic Robotic Trainer (DHRT) or the Advanced Dynamic Haptic Robotic Trainer (DHRT+). The resident's performance will be measured and evaluated by these devices during training. The technique of the training does not differ from what is currently taught at either institution. Residents will be required to pass the same skills assessment currently required at their institution. Upon successfully passing the skills assessment, residents will perform central venous catheterization procedures under supervision. The investigators will examine patient files at Milton S. Hershey Medical Center to determine changes in central line-related complication and infection rates associated with the introduction of these training devices.
Descripción general del estudio
Estado
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Pennsylvania
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Hershey, Pennsylvania, Estados Unidos, 17033
- Hershey 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
First-year resident undergoing central venous catheterization training at Milton S. Hershey Medical Center or Cedars-Sinai Medical Center, at least 18 years of age
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Residents to receive Dynamic Haptic Robotic Training
First-year residents at Milton S. Hershey Medical Center or Cedars Sinai Medical Center trained using the Dynamic Haptic Robotic Trainer (DHRT), a device that trains residents to safely perform the needle insertion component of central venous catheterization." |
Device trains medical residents to safely perform the needle insertion portion of Central Venous Catheterization. |
|
Experimental: Residents to receive Advanced Dynamic Haptic Robotic Training
First-year residents at Milton S. Hershey Medical Center or Cedars Sinai Medical Center trained using the Advanced Dynamic Haptic Robotic Trainer (DHRT+), which offers whole-procedure training. |
Device offers whole procedural training for medical residents to safely perform the procedure of Central Venous Catheterization. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Number of Internal Jugular Central Venous Catheters With and Without Mechanical Complication
Periodo de tiempo: Residents trained in 2021 (tracked insertion year 2022) for the DHRT period; residents trained in 2022-2024 (tracked insertion years 2023-2025) for the DHRT+ period.
|
Mechanical complications were defined as a composite outcome including hematoma, arterial puncture, pneumothorax, hemothorax, catheter misplacement, and vessel stenosis, identified using diagnosis codes from the International Classification of Diseases that were flagged as not present at the time of hospital admission. Outcome data reflects retrospective chart review at Milton S. Hershey Medical Center. DHRT deployment began June 2021; DHRT+ began June 2022. Data collection is complete. |
Residents trained in 2021 (tracked insertion year 2022) for the DHRT period; residents trained in 2022-2024 (tracked insertion years 2023-2025) for the DHRT+ period.
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Number of Internal Jugular Central Venous Catheters With and Without Thrombotic Complication
Periodo de tiempo: Residents trained in 2021 (tracked insertion year 2022) for the DHRT period; residents trained in 2022-2024 (tracked insertion years 2023-2025) for the DHRT+ period.
|
Thrombotic complications were defined as venous or arterial thrombosis, including catheter-associated device thrombosis, identified using diagnosis codes from the International Classification of Diseases that were flagged as not present at the time of hospital admission. Outcome data reflects retrospective chart review at Milton S. Hershey Medical Center. DHRT deployment began June 2021; DHRT+ began June 2022. Data collection is complete. |
Residents trained in 2021 (tracked insertion year 2022) for the DHRT period; residents trained in 2022-2024 (tracked insertion years 2023-2025) for the DHRT+ period.
|
|
Number of Internal Jugular Central Venous Catheters With and Without Infectious Complication
Periodo de tiempo: Residents trained in 2021 (tracked insertion year 2022) for the DHRT period; residents trained in 2022-2024 (tracked insertion years 2023-2025) for the DHRT+ period.
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Infectious complications were defined as a composite outcome including catheter-site infection and central line-associated bloodstream infection, identified using diagnosis codes from the International Classification of Diseases that were flagged as not present at the time of hospital admission. Outcome data reflects retrospective chart review at Milton S. Hershey Medical Center. DHRT deployment began June 2021; DHRT+ began June 2022. Data collection is complete. |
Residents trained in 2021 (tracked insertion year 2022) for the DHRT period; residents trained in 2022-2024 (tracked insertion years 2023-2025) for the DHRT+ period.
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Scarlett R Miller, Ph.D., Penn State University
- Investigador principal: Jason Z. Moore, Ph.D., Penn State University
- Director de estudio: Sanaz Motamedi, PhD, Penn State University
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
- STUDY00012206
- R01HL127316 (Subvención/contrato del NIH de EE. UU.)
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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