Air-in-Line Alarms During Antineoplastic Drug Infusion

NCT07718711 | Not Yet Recruiting

• 1 other identifier: AIIAO-AIRINLINE-2026
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Infusion Safety; Medication Safety; Antineoplastic Drug Administration; Air-in-Line Alarm

Keywords

Antineoplastic agents; Infusion pumps; Air-in-line alarms; Oncology nursing; High-alert medications; User experience; Infusion safety; Alarm management; Entrustable Professional Activities

Outcome Measures

Primary Outcomes (1)

• Frequency and Type of Infusion Alarms

  Number and type of infusion alarms, including air-in-line alarms, recorded during simulated and real-world antineoplastic infusion procedures.

  Up to 24 months

Secondary Outcomes (6)

• 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

Study Arms (1)

Healthcare Professionals Involved in Antineoplastic Drug Infusion

Healthcare professionals involved in routine antineoplastic drug infusion procedures in participating oncology centers. Participants will be observed during routine clinical practice to evaluate infusion alarms, alarm management strategies, infusion safety practices, and user experience with infusion technologies.

Other: Routine Infusion Technologies

Interventions

Routine Infusion Technologies OTHER

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.

Healthcare Professionals Involved in Antineoplastic Drug Infusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthcare professionals involved in routine intravenous administration of antineoplastic drugs in participating oncology centres. The study will observe routine infusion procedures to evaluate infusion alarms, alarm management strategies, adherence to infusion safety practices, and user experience with infusion technologies. Infusion procedures constitute the primary unit of observation, while healthcare professionals constitute the study participants.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Associazione Italiana Infermieri di Area Oncologica: lead
• IRCCS Multimedica: collaborator
• University of Milan: collaborator

Study Sites (5)

AUSL Parma

Parma, Emilia-Romagna, 43126, Italy

Location

Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, Lazio, 00168, Italy

Location

ASST Lodi

Lodi, Lombardy, 26900, Italy

Location

IRCCS Ospedale San Raffaele

Milan, Lombardy, 20132, Italy

Location

IEO - Istituto Europeo di Oncologia

Milan, Lombardy, 20141, Italy

Location

Central Study Contacts

Rosario Caruso, PhD, RN, FESNO, FAAN

CONTACT

+ 39 02503 15119; rosario.caruso@unimi.it

Greta Ghizzardi, PhD, RN

CONTACT

+39 0371376565; greta.ghizzardi@asst-lodi.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2026
• First Posted: July 22, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: July 22, 2026

Record last verified: 2026-07

Locations

IT (5)