Effectiveness of Ultrasound-Guided Versus Traditional IV Insertion by Oncology Nurses in Adult Population Recieving Systemic Anti-cancer Therapy

NCT07208175 | Recruiting DMC

• 2 other identifiers: Ref: C.A 3374CNRA21DUG.
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  At time of PIVC insertion (single insertion episode; assessed immediately following the procedure)

Study Arms (2)

Ultrasound-Guided Peripheral Intravenous Catheter (PIVC) Insertion

EXPERIMENTAL

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

ACTIVE COMPARATOR

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

Interventions

Traditional Peripheral Intravenous Catheter Insertion OTHER

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.

Traditional (Touch-and-Feel) Peripheral Intravenous Catheter (PIVC) Insertion

Ultrasound-Guided Peripheral Intravenous Catheter Insertion OTHER

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.

Ultrasound-Guided Peripheral Intravenous Catheter (PIVC) Insertion

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients younger than 18 years.
• Individuals unable to provide informed consent.
• Individuals unable to cooperate with study procedures (e.g., cognitive or physical limitations preventing adherence).

Sponsors & Collaborators

• University of Galway: lead

Study Sites (2)

Galway University Hospital

Galway, Ireland, H91 E3YV, Ireland

RECRUITING

Portiuncula University Hospital

Galway, H53 T971, Ireland

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

• Caitriona Duggan

  University of Galway

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Caitriona Duggan

CONTACT

+353872213936; c.duggan23@universityofgalway.ie

Peter J Carr

CONTACT

+35391492833; peter.carr@universityofgalway.ie

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD candidate

Study Record Dates

• First Submitted: September 27, 2025
• First Posted: October 6, 2025
• Study Start: October 20, 2025
• Primary Completion (Estimated): May 28, 2026
• Study Completion (Estimated): May 30, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: De-identified individual participant data (IPD) will be made available after publication of the primary trial results. Data will remain available for up to 7 years following publication.
• Access Criteria: De-identified individual participant data (IPD) and supporting documents (including the study protocol, statistical analysis plan, and informed consent form) will be made available to qualified researchers affiliated with academic institutions, healthcare organizations, or non-commercial research groups. Access will be granted for scientifically and ethically approved research projects. Researchers must submit a written request to the corresponding author outlining the study objectives, methods, and intended use of the data. Requests will be reviewed by the trial sponsor and principal investigators. Upon approval, a data access agreement must be signed before IPD is shared. Data will be provided in secure electronic format in compliance with GDPR and institutional policies.

Locations

IE (2)