Infusion SafetyAIR-ONCNCT07718711
Air-in-Line Alarms During Antineoplastic Drug Infusion
An observational study of Infusion Safety and Medication Safety, run by Associazione Italiana Infermieri di Area Oncologica at 5 sites in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infusion Safety, Medication Safety, Antineoplastic Drug Administration
- What is being tested?
- Routine Infusion Technologies
- Type of treatment
- Injection or infusion
- How many people
- 40 participants
- Where
- 5 sitesItaly
- Study dates
- 1 Jul 2026to 1 Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Italy5 sites
ASST Lodi
Lodi, Lombardy, 26900
Greta Ghizzardi, PhD, RN, + 39 0371376565, greta.ghizzardi@asst-lodi.it
IRCCS Ospedale San Raffaele
Milan, Lombardy, 20132
Anna Carmagliola, RN, MSN, + 39 02.26431, carmagnola.anna@hsr.it
IEO - Istituto Europeo di Oncologia
Milan, Lombardy, 20141
Giorgio Magon, RN, MSN, +39 02 574891, giorgio.magon@ieo.it
AUSL Parma
Parma, Emilia-Romagna, 43126
Marco A Arcidiacono, RN, MSN, +39 347 5255859, marcoalfredo.arcidiacono@unipr.it
Fondazione Policlinico Universitario A. Gemelli IRCCS
Rome, Lazio, 00168
Monica Liberatori, RN, MSN, +39 06 3015 4275, monica.liberatori@policlinicogemelli.it
About this study
Official title: Innovation in Antineoplastic Drug Infusion: A Multiphase Observational Study of Air-in-Line Alarms, Safety, and Therapeutic Continuity
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:
Read more
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.
Read the 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.
- Being tested
- Routine Infusion Technologies
- Keywords
- Antineoplastic agents, Infusion pumps, Air-in-line alarms, Oncology nursing, High-alert medications, User experience, Infusion safety, Alarm management, Entrustable Professional Activities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine Infusion TechnologiesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Routine Infusion Technologies |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 24 months
Secondary outcomes (6)
Adherence to Evidence-Based Infusion Safety Practices
Observed adherence to predefined safety behaviors and procedures during antineoplastic drug infusion and infusion alarm management.
Measured: Up to 24 months
User Experience With Infusion Technologies
Healthcare professionals' user experience scores regarding usability, alarm clarity, perceived safety, workload, confidence, and overall satisfaction with infusion devices.
Measured: Up to 24 months
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.
Measured: Up to 24 months
Alarm Management Time
Time in minutes required to manage infusion alarms and restore infusion continuity.
Measured: Up to 24 months
Inter-Center Variability in Alarm Management
Variability in alarm frequency, alarm management time, and operational strategies across participating oncology centers.
Measured: Up to 24 months
Factors Associated With Alarm Occurrence and Management
Clinical, technological, and organisational factors associated with infusion alarm occurrence, alarm management time, and user experience indicators.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infusion SafetyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Associazione Italiana Infermieri di Area Oncologica
- Sponsor type
- University, hospital or other
- Collaborators
- IRCCS Multimedica, University of Milan
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07718711
- Sponsor's protocol ID
- AIIAO-AIRINLINE-2026
- Acronym
- AIR-ONC
- Status last verified
- Jul 2026
- First submitted
- 16 Jul 2026
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovation in Antineoplastic Drug Infusion: A Multiphase Observational Study of Air-in-Line Alarms, Safety, and Therapeutic Continuity
- ClinicalTrials.gov ID
- NCT07718711
- Acronym / sponsor ID
- AIR-ONC / AIIAO-AIRINLINE-2026
- Keywords
- Antineoplastic agents, Infusion pumps, Air-in-line alarms, Oncology nursing, High-alert medications, User experience, Infusion safety, Alarm management
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Associazione Italiana Infermieri di Area OncologicaUniversity, hospital or other
- Collaborators
- IRCCS Multimedica, University of Milan
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 22 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthcare Professionals Involved in Antineoplastic Drug Infusion | – | Other: Routine Infusion TechnologiesHealthcare 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Routine Infusion TechnologiesObservation 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. | Other | Healthcare Professionals Involved in Antineoplastic Drug Infusion |
Primary outcome
Frequency and Type of Infusion Alarms
Time frame: Up to 24 months
Number and type of infusion alarms, including air-in-line alarms, recorded during simulated and real-world antineoplastic infusion procedures.
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infusion Safety and Medication Safety, run by Associazione Italiana Infermieri di Area Oncologica at 5 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rosario Caruso, PhD, RN, FESNO, FAAN (+ 39 02503 15119, rosario.caruso@unimi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency and Type of Infusion Alarms (time frame: Up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.