Air-in-Line Alarms During Antineoplastic Drug Infusion (AIR-ONC)
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:
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.
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Rosario Caruso, PhD, RN, FESNO, FAAN
- 전화번호: + 39 02503 15119
- 이메일: rosario.caruso@unimi.it
연구 연락처 백업
- 이름: Greta Ghizzardi, PhD, RN
- 전화번호: +39 0371376565
- 이메일: greta.ghizzardi@asst-lodi.it
연구 장소
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Emilia-Romagna
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Parma, Emilia-Romagna, 이탈리아, 43126
- AUSL Parma
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연락하다:
- Marco A Arcidiacono, RN, MSN
- 전화번호: +39 347 5255859
- 이메일: marcoalfredo.arcidiacono@unipr.it
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Lazio
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Rome, Lazio, 이탈리아, 00168
- Fondazione Policlinico Universitario A. Gemelli IRCCS
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연락하다:
- Monica Liberatori, RN, MSN
- 전화번호: +39 06 3015 4275
- 이메일: monica.liberatori@policlinicogemelli.it
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Lombardy
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Lodi, Lombardy, 이탈리아, 26900
- ASST Lodi
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연락하다:
- Greta Ghizzardi, PhD, RN
- 전화번호: + 39 0371376565
- 이메일: greta.ghizzardi@asst-lodi.it
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Milan, Lombardy, 이탈리아, 20132
- IRCCS Ospedale San Raffaele
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연락하다:
- Anna Carmagliola, RN, MSN
- 전화번호: + 39 02.26431
- 이메일: carmagnola.anna@hsr.it
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Milan, Lombardy, 이탈리아, 20141
- IEO - Istituto Europeo di Oncologia
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연락하다:
- Giorgio Magon, RN, MSN
- 전화번호: +39 02 574891
- 이메일: giorgio.magon@ieo.it
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
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.
|
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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Frequency and Type of Infusion Alarms
기간: Up to 24 months
|
Number and type of infusion alarms, including air-in-line alarms, recorded during simulated and real-world antineoplastic infusion procedures.
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Up to 24 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Adherence to Evidence-Based Infusion Safety Practices
기간: Up to 24 months
|
Observed adherence to predefined safety behaviors and procedures during antineoplastic drug infusion and infusion alarm management.
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Up to 24 months
|
|
User Experience With Infusion Technologies
기간: Up to 24 months
|
Healthcare professionals' user experience scores regarding usability, alarm clarity, perceived safety, workload, confidence, and overall satisfaction with infusion devices.
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Up to 24 months
|
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Operational Strategies for Infusion Alarm Management
기간: Up to 24 months
|
Strategies adopted by healthcare professionals to manage infusion alarms and maintain or restore infusion continuity during antineoplastic drug administration.
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Up to 24 months
|
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Alarm Management Time
기간: Up to 24 months
|
Time in minutes required to manage infusion alarms and restore infusion continuity.
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Up to 24 months
|
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Inter-Center Variability in Alarm Management
기간: Up to 24 months
|
Variability in alarm frequency, alarm management time, and operational strategies across participating oncology centers.
|
Up to 24 months
|
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Factors Associated With Alarm Occurrence and Management
기간: Up to 24 months
|
Clinical, technological, and organisational factors associated with infusion alarm occurrence, alarm management time, and user experience indicators.
|
Up to 24 months
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- AIIAO-AIRINLINE-2026
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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