Innovation in Antineoplastic Drug Infusion: A Multiphase Observational Study of Air-in-Line Alarms, Safety, and Therapeutic Continuity
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 5
- 主要终点
- Frequency and Type of Infusion Alarms
研究概览
简要总结
The goal of this observational study is to evaluate infusion alarms, particularly air-in-line alarms, during antineoplastic drug infusion in oncology care settings.
The main questions it aims to answer are:
How frequently do infusion alarms occur, and what types of alarms are observed during antineoplastic drug infusion? How long does it take healthcare professionals to manage infusion alarms and restore infusion continuity? What strategies do healthcare professionals use to manage infusion alarms? How do healthcare professionals evaluate the user experience of different infusion technologies?
Participants will be healthcare professionals involved in antineoplastic drug infusion. They will not receive any experimental intervention. Researchers will observe routine infusion procedures and collect data on alarm events, alarm management, infusion technologies, and user experience.
详细描述
ntravenous administration of antineoplastic drugs represents a complex and high-risk clinical process. Antineoplastic agents are classified as high-alert medications because administration errors may lead to severe clinical consequences. One of the most relevant operational issues in infusion oncology practice is the occurrence of air-in-line alarms, which may interrupt drug administration, increase healthcare professionals' workload, and negatively affect therapeutic continuity. This issue may be particularly relevant with foaming drugs, which are more likely to generate microbubbles within infusion lines.
Despite the clinical relevance of infusion alarms, current literature does not provide robust real-world evidence regarding their prevalence, associated factors, or comparative performance of different infusion technologies in oncology settings. Furthermore, limited evidence is available regarding healthcare professionals' operational management of infusion alarms and user experience associated with infusion devices.
The present study is designed as a multicenter, prospective, observational, multiphase and multimethod study integrating three complementary methodological phases.
Phase 1 consists of a controlled preclinical simulation study using standardized foaming preparations and infusion systems to evaluate the occurrence of air-in-line alarms under simulated conditions.
Phase 2 consists of a prospective field observational study aimed at evaluating healthcare professionals' practices during antineoplastic drug infusion and infusion alarm management in real-world oncology settings. This phase applies the Entrustable Professional Activities framework to identify key professional competencies related to infusion safety and alarm management.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthcare professionals involved in the administration of antineoplastic drugs in participating oncology centres.
- •Employment in a participating study site during the study period.
- •Direct involvement in routine intravenous antineoplastic drug infusion procedures.
- •Participation in infusion procedures eligible for observation according to the study protocol.
排除标准
- •Healthcare professionals not directly involved in antineoplastic drug administration.
- •Healthcare professionals working outside participating study sites.
- •Temporary staff not routinely involved in infusion activities during the observation period.
- •Refusal to participate in study activities where local regulations require participant notification.
结局指标
主要结局
Frequency and Type of Infusion Alarms
时间窗: Up to 24 months
Number and type of infusion alarms, including air-in-line alarms, recorded during simulated and real-world antineoplastic infusion procedures.
次要结局
- Adherence to Evidence-Based Infusion Safety Practices(Up to 24 months)
- User Experience With Infusion Technologies(Up to 24 months)
- Operational Strategies for Infusion Alarm Management(Up to 24 months)
- Alarm Management Time(Up to 24 months)
- Inter-Center Variability in Alarm Management(Up to 24 months)
- Factors Associated With Alarm Occurrence and Management(Up to 24 months)