Air-in-Line Alarms During Antineoplastic Drug Infusion
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssociazione Italiana Infermieri di Area Oncologica
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Routine Infusion Technologies
Other interventionObservation 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.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Healthcare Professionals Involved in Antineoplastic Drug Infusion1 intervention
Trial outcomes
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.
Time frame
Up to 24 monthsSecondary outcomes
1
Adherence to Evidence-Based Infusion Safety Practices
Observed adherence to predefined safety behaviors and procedures during antineoplastic drug infusion and infusion alarm management.
Time frame
Up to 24 months2
User Experience With Infusion Technologies
Healthcare professionals' user experience scores regarding usability, alarm clarity, perceived safety, workload, confidence, and overall satisfaction with infusion devices.
Time frame
Up to 24 months3
Operational Strategies for Infusion Alarm Management
Strategies adopted by healthcare professionals to manage infusion alarms and maintain or restore infusion continuity during antineoplastic drug administration.
Time frame
Up to 24 months4
Alarm Management Time
Time in minutes required to manage infusion alarms and restore infusion continuity.
Time frame
Up to 24 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Associazione Italiana Infermieri di Area Oncologica
Lead sponsor
IRCCS Multimedica
Collaborator
University of Milan
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: