An interventional study of Ultrasound-Guided Peripheral Intravenous Catheter Insertion and Traditional Peripheral Intravenous Catheter Insertion in Cancer, sponsored by University of Galway. Recruiting at 2 sites in Ireland. Per ClinicalTrials.gov, last updated 2026-04-29.
Sponsored by University of Galway · Not applicable, Interventional, and Supportive care
What is this study about? This study is comparing two different methods nurses use to place an intravenous (IV) drip, which is needed for many cancer treatments.
Traditional method: The nurse finds a vein by touch and sight.
Ultrasound-guided method: The nurse uses a small, handheld ultrasound scanner to see the vein under the skin to help guide the needle.
Why is it important? Sometimes it can take more than one attempt to get an IV drip in place, which can be uncomfortable. For cancer patients, whose veins can be more fragile, this is a common challenge. This research will help us find out if using ultrasound helps get the IV in successfully on the first try more often, which can make the treatment experience better.
What does participation involve? If you choose to take part, you will be randomly assigned (like a coin toss) to have your IV placed with either the traditional method or the ultrasound method. The research team will then collect some information about the IV placement. Your participation is entirely voluntary and will not affect your standard medical care.
Brief Summary:
This study compares two different methods nurses use to place an intravenous (IV) drip, which is needed for many cancer treatments.
Traditional method: The nurse finds a vein by touch and sight.
Ultrasound-guided method: The nurse uses a small, handheld ultrasound scanner to see the vein under the skin to help guide the needle.
Sometimes it can take more than one attempt to get an IV drip in place, which can be uncomfortable. For cancer patients, whose veins can be more fragile, this is a common challenge. This research will help determine if using ultrasound helps achieve successful IV placement on the first try more often, which may improve the treatment experience.
Participation involves random assignment (like a coin toss) to have the IV placed with either the traditional method or the ultrasound method. The research team will then collect some information about the IV placement. Participation is entirely voluntary and will not affect standard medical care.
Detailed Description:
Peripheral intravenous catheter (PIVC) insertion is a fundamental procedure for administering systemic anti-cancer therapy (SACT). A significant clinical problem in oncology is the high prevalence of patients with difficult intravenous access (DIVA), leading to multiple insertion attempts, procedural pain, anxiety, and treatment delays. The traditional landmark technique, reliant on visual and palpatory cues, is often insufficient for this population.
Ultrasound guidance represents a potential technological advancement for PIVC insertion, allowing for visualization of deeper vasculature. While evidence supports its use in emergency and critical care settings, its efficacy and implementation within routine oncology nursing practice are not well-established. Existing studies in this specific population are limited and of low certainty.
This trial employs a pragmatic, mixed-methods design to evaluate the real-world effectiveness of ultrasound-guided PIVC insertion by trained oncology nurses compared to the standard technique. The embedded qualitative component is critical for understanding the contextual factors influencing implementation, including clinician acceptability and the patient experience, which are vital for guiding future scale-up if the intervention is proven effective.
The intervention involves a structured, competency-based training program for oncology nurses in ultrasound-guided vascular access, developed and delivered by clinical experts at the University of Galway. The program's curriculum is grounded in task analysis and includes supervised clinical practice to ensure procedural competency prior to participant enrollment.
The study is conducted across a spectrum of oncology care settings to enhance the generalizability of the findings. The design accounts for key clinical covariates known to influence insertion success, such as DIVA status, through stratified randomization and adjusted statistical models. Data collection integrates quantitative metrics with in-depth qualitative interviews to provide a comprehensive assessment of the intervention's impact on both clinical outcomes and human factors.
9,359 studies on the registry are indexed under Neoplasms; 2,486 are open to participants now.
This study's planned enrollment of 98 is above the median of 50 across 7,250 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →University of Galway is the lead sponsor of 5 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adults aged 18 years or older.
Diagnosed with cancer (all cancer sites eligible).
Scheduled to receive systemic anti-cancer therapy (SACT) such as chemotherapy, immunotherapy, or targeted therapies.
Requiring peripheral intravenous catheter (PIVC) insertion for treatment.
Exclusion Criteria:
Individuals unable to provide informed consent.
Individuals unable to cooperate with study procedures (e.g., cognitive or physical limitations preventing adherence).
Ultrasound-Guided Peripheral Intravenous Catheter (PIVC) Insertion Participants randomized to this arm will undergo PIVC insertion performed by trained oncology nurses using real-time ultrasound guidance. The ultrasound device will be used to assess and select a suitable vein, guide needle advancement, and confirm catheter placement. This approach is designed to improve first-time insertion success, preserve vein health, and reduce insertion-related complications compared to the traditional touch-and-feel technique.
Other: Ultrasound-Guided Peripheral Intravenous Catheter Insertion
Traditional (Touch-and-Feel) Peripheral Intravenous Catheter (PIVC) Insertion Participants randomized to this arm will receive PIVC insertion performed by oncology nurses using the standard landmark technique. This method relies on visual inspection and palpation of the vein to guide catheter placement, without the use of ultrasound. It reflects current routine clinical practice for establishing intravenous access in oncology patients.
Other: Traditional Peripheral Intravenous Catheter Insertion
In this arm, PIVC insertion is performed by oncology nurses who have completed a structured ultrasound training program. Nurses use real-time ultrasound imaging to identify and select a suitable vein, guide the advancement of the catheter, and confirm placement. This method contrasts with the standard touch-and-feel approach by incorporating ultrasound technology and specialized nurse training to improve first-time insertion success and reduce complications.
PIVC insertion performed by oncology nurses using the conventional touch-and-feel landmark technique, relying on visual inspection and palpation of veins. Represents current standard clinical practice in oncology.
First-time insertion success (FTIS) of peripheral intravenous catheter
Proportion of participants with successful peripheral intravenous catheter placement on the first skin-puncture attempt. Success is defined as successful cannulation on the first needle puncture with confirmation of a functioning PIVC by (1) visible/aspirable blood return and (2) ability to flush and infuse a standard 10 mL saline bolus without resistance or infiltration. The outcome is recorded as a binary variable (Yes/No) on the case report form by the treating/research nurse immediately after the procedure and used to calculate the percentage of FTIS per arm.
Time frame: At time of PIVC insertion (single insertion episode; assessed immediately following the procedure)
Plan to share: Yes — De-identified individual participant data (IPD) underlying the results reported in future publications will be made available to other researchers upon reasonable request to the corresponding author. Data sharing will require approval from the trial sponsor and a signed data access agreement. Data will only be shared for ethically approved research purposes and in compliance with GDPR and institutional policies.
Supporting information: Study protocol
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University of Galway