Peripheral Venous Access Management by Radiologic Technologists in Radiodiagnostic Procedure (TSRM_01)

Peripheral Venous Access Management by Radiologic Technologists in Radiodiagnostic Procedures: Training, Organization, and Patient Safety. Evaluation of a Structured Training Program and Its Clinical and Organizational Effects

The goal of this interventional study is to evaluate the impact of a structured training program on the ability of Radiologic Technologists (RTs) to safely and effectively perform peripheral venous access (PVA) placement for contrast media administration in a radiodiagnostic setting.

The study focuses on adult patients undergoing contrast-enhanced imaging procedures and on Radiologic Technologists who have completed a competency-based theoretical and practical training program on peripheral venous access management.

The main questions it aims to answer are:

• Does a structured training program improve the theoretical knowledge and technical competencies of Radiologic Technologists in peripheral venous access placement?
• What is the incidence of complications associated with peripheral venous access placement performed by trained Radiologic Technologists in routine clinical practice?
• How do patients perceive the procedure in terms of pain, safety, procedural success, and overall satisfaction?

Participants:

• Radiologic Technologists will participate in a structured theoretical and practical training program focused on peripheral venous access placement for contrast media administration.
• Radiologic Technologists will perform peripheral venous access placement during routine radiodiagnostic procedures following completion of the training.
• Patients undergoing contrast-enhanced imaging will receive peripheral venous access placement performed by trained Radiologic Technologists and will complete questionnaires assessing pain, satisfaction, and perceived safety of the procedure.

Study Overview

• Status: Not yet recruiting
• Conditions: Patient Satisfaction; Clinical Practice; Skill Development of Staff
• Intervention / Treatment: Other: Structured Peripheral Venous Access Training Program

Detailed Description

This prospective, single-center, single-arm interventional study aims to evaluate the quality and impact of a structured theoretical and practical training program designed to qualify Radiologic Technologists (RTs) to perform peripheral venous access (PVA) placement for contrast media administration in a radiodiagnostic setting.The primary objective is to assess the effectiveness of the training program by evaluating the acquisition of technical competencies and theoretical knowledge among RTs. In addition, the study evaluates the clinical impact of the intervention in routine practice by analyzing the incidence of PVA-related complications and the patient experience in terms of pain perception, procedural success, and perceived safety.Secondary objectives include assessing RTs' perceptions of the training program with regard to organization, clarity of content, educational effectiveness, and perceived impact on professional practice. The study also aims to measure the incidence of adverse events associated with PVA placement performed by trained RTs and to examine patient-reported outcomes, including pain, first-attempt success rate, procedure duration, and overall satisfaction.

Study Design and Duration: This is an interventional, prospective, single-center, single-arm study that does not involve investigational drugs or medical devices. The intervention consists exclusively of a competency-based training program. The study will begin following Ethics Committee approval and administrative authorization and will have a total planned duration of six months.

The first month (Phase 1 - Intervention Implementation) will include delivery of the theoretical and practical training program and supervised clinical practice. Each RT will complete at least 20 supervised PVA placements. At the end of this phase, RTs will complete a structured survey assessing training effectiveness and perceived preparedness.The following four months (Phase 2 - Intervention Evaluation) will involve data collection during routine clinical activity, with RTs independently performing PVA placement and completing standardized data collection forms. The final month will be dedicated to data analysis and reporting.

Study Setting The study will be conducted at the Radiodiagnostic Service of the Columbus site of the Fondazione Policlinico Universitario A. Gemelli IRCCS in Rome. Study activities will primarily take place in the computed tomography (CT) unit, where contrast media administration routinely requires PVA placement. All procedures will be performed as part of routine clinical practice following completion of the training program, in accordance with institutional procedures and international guidelines for short peripheral venous catheter insertion.

Study Population The study population includes Radiologic Technologists working in the Radiodiagnostic Service and adult patients undergoing contrast-enhanced imaging examinations. Approximately 384 adult patients (≥18 years) undergoing CT or MRI examinations requiring contrast media administration will be included. RT inclusion criteria, include voluntary participation with informed consent and completion of the training program. RTs who do not provide informed consent will be excluded.Patient inclusion criteria include age ≥18 years, informed consent, and clinical indication for PVA placement. Exclusion criteria include age <18 years, severe cognitive impairment, lack of informed consent, and clinical conditions that make venipuncture complex or unsafe.

Ethical Considerations, All study activities involving healthcare professionals will be conducted in accordance with institutional procedures governing employee participation in research. Participation will be voluntary and based on informed consent. Information sessions will ensure that participants fully understand study objectives, procedures, risks, and benefits, and that participation is free from coercion or undue influence.Intervention and Operational Procedures The intervention consists of a structured theoretical and practical training pathway aimed at qualifying RTs to perform PVA placement. Training will be delivered by expert instructors with academic teaching experience and advanced clinical expertise in vascular access management. Practical training will be supported by experienced nurses acting as tutors during supervised clinical practice.Upon completion of the training, RTs will receive certification of competency and complete a structured survey evaluating the training program. During the evaluation phase, RTs will perform PVA placement in routine clinical practice, and patient data will be collected following an information session and informed consent process.

Data Collection and Outcomes Training effectiveness will be assessed through structured surveys and competency assessments administered to RTs. Secondary outcomes include the proportion of PVA-related complications (e.g., hematoma, phlebitis, procedural failure), first-attempt success rate, procedure duration, and patient-reported outcomes related to pain, satisfaction, and perceived safety.Data will be recorded using standardized data collection tools and entered into a structured electronic dataset. Continuous monitoring by the research team will ensure data quality and protocol adherence. Immediate post-procedural assessments will be conducted to document any complications or adverse events.

• Study Type: Interventional
• Enrollment (Estimated): 9
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Danilo Pasini; Phone Number: +39 3332213200; Email: danilo.pasini@policlinicogemelli.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria for Radiologic Technologists (RTs):

• Voluntary participation and provision of written informed consent.
• Completion of the structured theoretical and practical training program for peripheral venous access placement for contrast media administration.

Inclusion Criteria for Patients:

• Age ≥18 years
• Provision of written informed consent.
• Undergoing a contrast-enhanced CT or MRI examination requiring peripheral venous access placement for contrast media administration.

Exclusion Criteria for Radiologic Technologists (RTs):

- No written informed consent.

Exclusion Criteria for Patients:

• Age <18 years.
• Severe cognitive impairment that precludes valid informed consent or completion of the patient survey.
• No written informed consent.
• Clinical conditions that make peripheral venous access placement complex or unsafe, as determined by the clinical team.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: RT's arm; Radiologic Technologists receiving structured peripheral venous access training

Other: Structured Peripheral Venous Access Training Program; The intervention consists of a structured, competency-based theoretical and practical training program designed to qualify Radiologic Technologists to independently perform peripheral venous access placement for contrast media administration. The program includes classroom-based education, supervised hands-on training, and on-the-job mentoring focused on venipuncture techniques, prevention and recognition of complications, and patient communication. Competency is achieved after completion of the training pathway and a minimum number of supervised procedures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness of the Structured Theoretical-Practical Training Program on Peripheral Venous Access Placement	Effectiveness of the training program will be assessed through: A structured post-training survey evaluating perceived knowledge acquisition, preparedness, autonomy, and overall training impact (categorical Likert-type responses), and; A structured practical competency assessment evaluating procedural performance. Survey responses will be reported as absolute frequencies (n) and percentages (%) for each response category. Practical competency will be reported as: Proportion (%) of Radiologic Technologists achieving successful completion of supervised peripheral venous access procedures, and; Proportion (%) reaching predefined competency level after training.	one month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Peripheral Venous Access-Related Complications	The proportion of procedures in which at least one complication related to peripheral venous access placement for contrast media administration occurs. Complications will include hematoma/bruising, bleeding, phlebitis/local inflammation, infiltration/extravasation, and procedural failure. Results will be reported as: Number (n) and percentage (%) of procedures with ≥1 complication; Number (n) and percentage (%) by type of complication	Up to 4 months
First-Attempt Success Rate of Peripheral Venous Access Placement	The proportion of procedures successfully completed at the first venipuncture attempt. Results will be reported as: Number (n) and percentage (%) of procedures completed at first attempt; Distribution of procedures requiring second or ≥3 attempts (n, %)	Up to 4 months
Patient-Reported Pain During and After Peripheral Venous Access Placement	Patient-reported pain intensity during venipuncture and duration of post-procedural pain will be assessed using categorical response options. Results will be reported as: Number (n) and percentage (%) for each pain intensity category; Number (n) and percentage (%) for each pain duration category	Immediately after procedure (Up to 4 months)
Patient-Reported Procedural Experience and Satisfaction	Patient-reported overall experience and perceived clarity/availability of healthcare staff during the radiologic examination. Responses will be collected using categorical Likert-type options. Results will be reported as: Number (n) and percentage (%) for each response category; Proportion (%) reporting positive or very positive experience	Immediately after procedure (Up to 4 months)
Procedure Duration (Arrival to Examination Start)	Time elapsed from arrival in the examination room to the beginning of the radiologic procedure, categorized into predefined time intervals. Results will be reported as: • Number (n) and percentage (%) for each time category	Up to 4 months

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Investigators: Principal Investigator: Danilo Pasini, Fondazione Policlinico Universitario A. Gemelli, IRCCS

Study record dates

Study Major Dates

• Study Start (Estimated): February 15, 2026
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): August 15, 2026

Study Registration Dates

• First Submitted: January 21, 2026
• First Submitted That Met QC Criteria: February 11, 2026
• First Posted (Actual): February 13, 2026

Study Record Updates

• Last Update Posted (Actual): February 13, 2026
• Last Update Submitted That Met QC Criteria: February 11, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Nurse; interdisciplinarity; skills; education program; venipunture; RT's; Radiation Technologists
• Additional Relevant MeSH Terms: Behavior; Treatment Adherence and Compliance; Health Behavior; Patient Satisfaction
• Other Study ID Numbers: 7543

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No