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Simulation-Based Intrathecal Pump Refill Training (REFILL-IT)

2026年10月1日 更新者：Universitair Ziekenhuis Brussel

Optimizing Intrathecal Pump Refill Training: A Simulation-Based Study of Learning Curves and Procedural Competence.

Intrathecal drug delivery is an effective treatment option for patients with chronic (non-) cancer pain or spasticity who do not achieve sufficient benefit from conventional therapies. After intrathecal pump implantation, intrathecal pump refilling is an essential postoperative maintenance procedure that requires procedural competence to be performed safely and consistently. Despite the absence of a standardized intrathecal pump refill protocol, the REFFIL-IT study aims to train 40 participants in intrathecal pump refilling. Based on the learning curve during simulation-based training and the number of complete simulated refill procedures required to achieve stable procedural competence, a step-by-step standardized intrathecal pump refill protocol will be developed. The REFILL-IT study aims to contribute to the safe and correct intrathecal pump refilling in patients with chronic (non-) cancer pain and spasticity.

研究概览

地位

尚未招聘

条件

干预/治疗

研究类型

介入性

注册 (估计的)

40

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 比利时
      • Jette、比利时、1090
        • UZ Brussel/VUB
        • 接触：
        • 副研究员：
          • Ulrike Van Hoey, MSc
        • 副研究员：
          • Britt Winnepenninckx, MSc
        • 首席研究员：
          • Maarten Moens, MD, PhD, MBA
        • 副研究员：
          • Lisa Goudman, MSc, PhD, MBA

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Healthcare professionals
  • (Healthcare) students;
  • Aged ≥18 years;
  • No prior independent performance of intrathecal pump refill procedures;
  • Dutch speaking.

Exclusion Criteria:

  • Visual impairments preventing participation in stimulated-based intrathecal pump training;
  • Conditions such as severe neurological or musculoskeletal disorders affecting hand function that preclude participation in the training.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：支持治疗
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Simulation-based intrathecal pump refill training
程序：Simulation-based intrathecal pump refill training

The REFILL-IT study consists of two mandatory phases and an optional third clinical phase.

During the Knowledge Acquisition Phase, participants will receive theoretical and practical instruction through educational videos and a written step-by-step guide. Progression requires successful completion of a knowledge assessment covering the refill procedure.

In the Skill Development Phase, participants will repeatedly perform simulated intrathecal pump refill procedures using explanted SynchroMed II™ (Medtronic) dummy pumps positioned beneath a 15-mm silicone skin pad. Each procedure will be assessed as either successful or unsuccessful to evaluate the development of procedural competence.

Participants who achieve stable competence and are physicians legally authorized to perform intrathecal pump refills in Belgium may progress to the Clinical Application Phase, where they will perform refill procedures in patients under the direct supervision of an experienced healthcare professional.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Number of complete simulated intrathecal pump refill procedures required to achieve stable procedural competence
大体时间：Immediately after the intervention, namely after the simulated intrathecal pump refill procedures during the Skill Development Phase and during the Clinical Application Phase

The number of complete simulated intrathecal pump refill procedures required to achieve stable procedural competence will be determined using Learning Curve Cumulative Sum (LC-CUSUM) analysis.
Immediately after the intervention, namely after the simulated intrathecal pump refill procedures during the Skill Development Phase and during the Clinical Application Phase

次要结果测量

结果测量
措施说明
大体时间
Total Objective Structured Assessment of Technical Skills (OSATS) score per simulated refill procedure
大体时间：Immediately after the intervention, namely after the simulated intrathecal pump refill procedures during the Skill Development Phase and during the Clinical Application Phase

Each (simulated) refill procedure will be evaluated using an OSATS-based assessment tool, assessing four predefined domains: aseptic technique, correct port access, volume verification, and procedural safety.
Immediately after the intervention, namely after the simulated intrathecal pump refill procedures during the Skill Development Phase and during the Clinical Application Phase
Attempt-level success or failure
大体时间：Immediately after the intervention, namely after the simulated intrathecal pump refill procedures during the Skill Development Phase and during the Clinical Application Phase

Each (simulated) refill procedure will be classified as successful or failed based on the OSATS score and the occurrence of critical procedural errors.
Immediately after the intervention, namely after the simulated intrathecal pump refill procedures during the Skill Development Phase and during the Clinical Application Phase
Number and type of critical procedural errors
大体时间：Immediately after the intervention, namely after the simulated intrathecal pump refill procedures during the Skill Development Phase and during the Clinical Application Phase

The number and type of critical procedural errors occurring during each simulated refill procedure will be recorded.
Immediately after the intervention, namely after the simulated intrathecal pump refill procedures during the Skill Development Phase and during the Clinical Application Phase
Number and type of procedural errors
大体时间：Immediately after the intervention, namely after the simulated intrathecal pump refill procedures during the Skill Development Phase and during the Clinical Application Phase

Non-critical procedural errors, including minor deviations, delays, and technical difficulties, will be recorded during each (simulated) refill procedure.
Immediately after the intervention, namely after the simulated intrathecal pump refill procedures during the Skill Development Phase and during the Clinical Application Phase
Proportion of participants achieving stable procedural competence within the predefined training phase
大体时间：Immediately after the intervention, namely after the simulated intrathecal pump refill procedures during the Skill Development Phase and during the Clinical Application Phase

The number of participants achieving stable procedural competence according to the predefined LC-CUSUM decision rule will be recorded, or until a maximum of 16 complete simulated refill procedures has been reached.
Immediately after the intervention, namely after the simulated intrathecal pump refill procedures during the Skill Development Phase and during the Clinical Application Phase
Number of participants requiring additional supervised practice or remediation after the predefined training phase
大体时间：Immediately after the intervention, namely after the simulated intrathecal pump refill procedures during the Skill Development Phase and during the Clinical Application Phase

The number of participants requiring additional supervised practice or remediation will be recorded.
Immediately after the intervention, namely after the simulated intrathecal pump refill procedures during the Skill Development Phase and during the Clinical Application Phase
Number of port-access attempts per simulated refill procedure
大体时间：Immediately after the intervention, namely after the simulated intrathecal pump refill procedures during the Skill Development Phase and during the Clinical Application Phase

The number of port-access attempts per (simulated) refill procedure will be recorded, with a maximum of three attempts per procedure.
Immediately after the intervention, namely after the simulated intrathecal pump refill procedures during the Skill Development Phase and during the Clinical Application Phase
Total procedure time of a complete simulated refill procedure
大体时间：Immediately after the intervention, namely after the simulated intrathecal pump refill procedures during the Skill Development Phase and during the Clinical Application Phase

The total time required to complete each (simulated) intrathecal pump refill procedure will be recorded.
Immediately after the intervention, namely after the simulated intrathecal pump refill procedures during the Skill Development Phase and during the Clinical Application Phase
Time required for individual procedural steps
大体时间：Immediately after the intervention, namely after the simulated intrathecal pump refill procedures during the Skill Development Phase and during the Clinical Application Phase

The time required for individual procedural steps during a (simulated) intrathecal pump refill procedure will be recorded.
Immediately after the intervention, namely after the simulated intrathecal pump refill procedures during the Skill Development Phase and during the Clinical Application Phase

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Universitair Ziekenhuis Brussel

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年11月1日

初级完成 (估计的)

2028年10月1日

研究完成 (估计的)

2028年10月1日

研究注册日期

首次提交

2026年9月7日

首先提交符合 QC 标准的

2026年10月1日

首次发布 (实际的)

2026年10月2日

研究记录更新

最后更新发布 (实际的)

2026年10月2日

上次提交的符合 QC 标准的更新

2026年10月1日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • 26298_REFILL-IT

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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