Air-in-Line Alarms During Antineoplastic Drug Infusion
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Routine Infusion Technologies.
- Who it may be relevant to
- Registry conditions: Infusion Safety, Medication Safety, Antineoplastic Drug Administration, Air-in-Line Alarm. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Innovation in Antineoplastic Drug Infusion: A Multiphase Observational Study of Air-in-Line Alarms, Safety, and Therapeutic Continuity
Overview
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.
Detailed description
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.
Interventions
- Other Routine Infusion Technologies
Observation of routinely used infusion technologies and infusion-related alarm management during standard antineoplastic drug administration in oncology care settings. No experimental intervention or treatment allocation is performed.
Primary outcome measures
- Frequency and Type of Infusion Alarms [Time frame: Up to 24 months]
Secondary outcome measures (6)
- Adherence to Evidence-Based Infusion Safety Practices [Time frame: Up to 24 months]
- User Experience With Infusion Technologies [Time frame: Up to 24 months]
- Operational Strategies for Infusion Alarm Management [Time frame: Up to 24 months]
- Alarm Management Time [Time frame: Up to 24 months]
- Inter-Center Variability in Alarm Management [Time frame: Up to 24 months]
- Factors Associated With Alarm Occurrence and Management [Time frame: Up to 24 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 5 centers
- AUSL Parma — Parma
- Fondazione Policlinico Universitario A. Gemelli IRCCS — Rome
- ASST Lodi — Lodi
- IRCCS Ospedale San Raffaele — Milan
- IEO - Istituto Europeo di Oncologia — Milan
Identifiers
NCT: NCT07718711 · AIIAO-AIRINLINE-2026