- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT04541446
Study Dynamic Haptic Robotic Trainer (DHRT) and DHRT+ for Central Venous Catheterization Insertion Training for Residents
Изучите Dynamic Haptic Robotic Trainer (DHRT) и DHRT+ для обучения введению CVC для хирургических резидентов
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.
Обзор исследования
Статус
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
-
-
Pennsylvania
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Hershey, Pennsylvania, Соединенные Штаты, 17033
- Hershey Medical Center
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-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
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
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Другой
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: 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. |
|
Экспериментальный: 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. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Number of Internal Jugular Central Venous Catheters With and Without Mechanical Complication
Временное ограничение: 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.
|
|
Number of Internal Jugular Central Venous Catheters With and Without Thrombotic Complication
Временное ограничение: 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
Временное ограничение: 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.
|
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.
|
Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Scarlett R Miller, Ph.D., Penn State University
- Главный следователь: Jason Z. Moore, Ph.D., Penn State University
- Директор по исследованиям: Sanaz Motamedi, PhD, Penn State University
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Другие идентификационные номера исследования
- STUDY00012206
- R01HL127316 (Грант/контракт NIH США)
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .