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Идёт набор NCT07426679

Should Anaesthesiologists Be Taught to Perform Ultrasound-- Assisted Neuraxial Access in Spinal Anaesthesia?

Без фазы С лечением Ultrasound Spinal Anaesthesia Simulation Based Medical Education

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Ultrasound-assisted spinal anaesthesia, Control group.
Кому может быть актуально
Состояния в реестре: Ultrasound, Spinal Anaesthesia, Simulation Based Medical Education. Базовые параметры: 18 лет — 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Дания
Следующий шаг
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Официальное название

Should Anaesthesiologists Be Taught to Perform Ultrasound-- Assisted Neuraxial Access in Spinal Anaesthesia?-Protocol of a Randomised Controlled Study

Обзор

Neuraxial blockade is commonly performed using a manual palpation technique, but the procedure can be challenging, particularly in patients with high body mass index, pregnancy, or spinal deformities. Preprocedural ultrasound may improve identification of the optimal injection site, yet its use in clinical practice remains limited, partly due to a lack of structured training. This multicentre randomised controlled trial investigates whether anaesthesiologists performing ultrasound-assisted spinal anaesthesia achieve better clinical outcomes and higher patient satisfaction compared with the traditional manual palpation technique. Both novice anaesthesia residents and more experienced anaesthesiologists are included. Participants receive structured simulation-based training using either ultrasound-assisted or manual palpation techniques, following a mastery learning approach with predefined performance standards. After certification, participants perform spinal anaesthesia during elective lower limb surgery, with clinical performance assessed by senior anaesthesiologists. The primary outcome is first-attempt success of spinal block. Secondary outcomes include number of attempts, needle redirections, time spent, need for assistance, and overall block success. Patient satisfaction and complications are assessed as tertiary outcomes. This study aims to provide evidence on the clinical effects of structured training in ultrasound-assisted neuraxial access and to explore the role of prior clinical experience.

Вмешательства

  • Процедура Ultrasound-assisted spinal anaesthesia
    Participants will received simulation-based training in ultrasound-assisted spinal anaesthesia based on a mastery-based learning structure. Following this, they will perform two ultrasound-assisted spinal blocks on patients.
  • Процедура Control group
    Participants will receive simulation based training in traditional palpation technique for spinal anaesthesia based on a mastery learning concept. Follow this, they will perform two spinal blocks on participants using this method.

Первичные конечные точки

  • Successful first spinal block attempt [Срок оценки: During spinal blocks]
Вторичные конечные точки (10)
  • Number of attempts [Срок оценки: During block]
  • Number of redirections [Срок оценки: During block]
  • Successful block for operation [Срок оценки: During block]
  • Need for supervisor's verbal help [Срок оценки: during block]
  • Need for supervisor's technical assistance [Срок оценки: During block]
  • Time spent [Срок оценки: During block]
  • Need for sedation during spinal anaesthesia placement [Срок оценки: During block]
  • Additional intervention required intraoperatively- unexpected general anaesthesia [Срок оценки: During block]
  • Additional intervention required intraoperatively- need for sedation [Срок оценки: During block]
  • Expected difficult access [Срок оценки: During block]

Критерии участия

Критерии включения

  • Physicians will be included using the following inclusion criteria:
  • Physicians working in anaesthesia
  • Opportunity to use the spinal block technique within 2 weeks of the training session.

Eligible patients will be those scheduled for elective lower limb surgery requiring spinal anaesthesia.

Критерии исключения

  • Exclusion criteria: Patients under 18 years of age.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Другое

Центры проведения

Дания · 2 центра
  • Department of Anaesthesiology and Intensive care — Kolding
  • Martine Siw Nielsen — Kolding

Идентификаторы

NCT: NCT07426679 · 25/50538

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗