The Efficacy of Implementing Nurse-performed Ultrasound-guided Peripheral Intravenous Access in Oncology Patients

The Efficacy of Implementing Nurse-performed Ultrasound-guided Peripheral Intravenous Access in Oncology Patients: a Prospective Interventional Clinical Study

The purpose of this study is to investigate the clinical efficacy of nurse-performed ultrasound-guided intravenous access in oncology patients on the oncological outpatient unit in the National Hospital of the Faroe Islands.

Study Overview

• Status: Not yet recruiting
• Conditions: Supportive Care
• Intervention / Treatment: Device: Ultrasound

Detailed Description

This project is prospective, interventional, clinical study aligned in four different time stages.

In the first stage, the pre-implementation stage, procedures are as usual, where the patient receives intravenous access via the use of the traditional palpation technique and data will be registered. In the next stage, the training stage, the nurses on the oncological outpatient unit will be trained in the use of the ultrasound-guided technique to place peripheral intravenous catheters and will be supervised by specialists in ultrasound. In the third stage, the implementation stage, the nurses will use the ultrasound technique as a daily routine in their practice. In the fourth stage, the post-implementation stage, the same data registration as in the first stage will be registered (see outcome measures) and the results will be compared in order to see the efficacy before and after implementation of ultrasound guidance. It is estimated a total sample of 100 cannulation procedures with approximately 30 patients needed in the pre-implementation and post-implementation stages.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lisa Maria Anderssen, RN, MHS; Phone Number: (+298) 223820; Email: lisa.anderssen1989@gmail.com
• Study Contact Backup: Name: Maria Skaalum Petersen, MSc, PhD; Phone Number: (+298) 216695; Email: maria@health.fo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Cancer patients admitted to the oncological outpatient unit are eligible for inclusion if they are scheduled for treatment with chemotherapy requiring placement of peripheral intravenous catheter, aged 18 years or older, and reside in the Faroe Islands.

Exclusion Criteria:

• Lack of informed consent and mental incapacity.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ultrasound-guided peripheral intravenous access; The patients in the experimental arm will receive ultrasound-guided peripheral intravenous catheter placement, where the dynamic needle tip (DNTP) approach (short-axis) will be used.	Device: Ultrasound; Ultrasound-guided peripheral intravenous catheter insertion
Active Comparator: Traditional palpation intravenous access technique; The comparator group will receive the traditional palpation intravenous access technique.	Device: Ultrasound; Ultrasound-guided peripheral intravenous catheter insertion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
First attempt success rate	Placement of a functional peripheral intravenous catheter on the first attempt. Defined as retraction of the needle, blood in the plastic catheter, smooth insertion of the plastic catheter and subsequent flush with isotonic saline without signs of extravasal placement.	The time frame for the outcome measure first attempt succes rate for each participant is estimated 1 hour in the pre-implementation stage and 1 hour in the post-implementation stage.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of skin punctures	Total number of insertion attempts i.e., number of skin punctures needed to successfully insert a peripheral intravenous catheter	The time frame for the outcome measure number of attempts for each participant is estimated 1 hour in the pre-implementation stage and 1 hour in the post-implementation stage.
Patient's satisfaction	Arbitrary Likert scale 0-5	The time frame for the outcome measure patient´s satisfaction for each participant is estimated 1 hour in the pre-implementation stage and 1 hour in the post-implementation stage.
Patient's experience of pain	Numerical Rating Scale (NRS) scale 0-10	The time frame for the outcome measure patient´s experience of pain for each participant is estimated 1 hour in the pre-implementation stage and 1 hour in the post-implementation stage.
Durability	Is the chemotherpy session completed successfully (yes/no). Defined as intravenous chemotherapy successfully infused with only one peripheral intravenous catheter used.	The time frame for the outcome measure durability for each participant is estimated 4 hours in the pre-implementation stage and 4 hours in the post-implementation stage.
Intravenous complications	Intravenous complications such as e.g., infiltration, extravasation, vessel occlusion etc.	The time frame for the outcome measure intravenous complications for each participant is estimated 4 hours in the pre-implementation stage and 4 hours in the post-implementation stage.

Collaborators and Investigators

• Sponsor: Faroese Hospital System
• Collaborators: University of Aarhus; University of the Faroe Islands; The National Hospital of the Faroe Islands
• Investigators: Principal Investigator: Peter Juhl-Olsen, MD, PhD, Aarhus University Hospital; Principal Investigator: August Gabriel Wang, MD, DMSc, University of the Faroe Islands; Principal Investigator: Lisa Maria Anderssen, RN, MHS, Department of Research, the National Hospital of the Faroe Islands

Study record dates

Study Major Dates

• Study Start (Estimated): September 16, 2024
• Primary Completion (Estimated): October 16, 2025
• Study Completion (Estimated): February 16, 2026

Study Registration Dates

• First Submitted: August 20, 2024
• First Submitted That Met QC Criteria: August 27, 2024
• First Posted (Actual): August 29, 2024

Study Record Updates

• Last Update Posted (Actual): August 29, 2024
• Last Update Submitted That Met QC Criteria: August 27, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Oncology; Ultrasonography; Intravenous
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: Ultrasound IV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD data can be shared on a collaborative basis, provided the appropriate approvals

Drug and device information, study documents

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