Air-in-Line Alarms During Antineoplastic Drug Infusion

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.

Phase 3 consists of a prospective multicenter observational cohort study aimed at collecting real-world data regarding infusion alarms, alarm management time, operational strategies, and healthcare professionals' user experience with infusion technologies routinely used in clinical practice.

The study does not include experimental interventions, treatment allocation, or modifications to standard clinical practice. All infusion technologies included in the study are CE-marked medical devices routinely used in participating centers according to their intended purpose. No patient clinical data will be collected. Data collection will focus on infusion-related technical events, organizational variables, observable professional behaviors, and healthcare professionals' user experience.

The study will be conducted in five Italian oncology centers and is expected to last approximately 24 months following ethics approval and local authorization procedures. Data will be collected and managed using the REDCap electronic data capture platform. Statistical analyses will include descriptive and inferential methods aimed at identifying factors associated with infusion alarm occurrence, alarm management, and user experience outcomes.

The results of this study are expected to contribute to the development of evidence-based recommendations for safer infusion practices, optimization of oncology infusion workflows, and improvement of healthcare professionals' training related to infusion technologies and alarm management.

Inclusion criteria

• 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.

Exclusion criteria

• 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.