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NCT Number: NCT06578494

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ultrasound

Device

Ultrasound-guided peripheral intravenous catheter insertion

Primary outcomes

  1. First attempt success rate

    Time frame: 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.

    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.

Secondary outcomes

  1. Number of skin punctures

    Time frame: 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.

    Total number of insertion attempts i.e., number of skin punctures needed to successfully insert a peripheral intravenous catheter

  2. Patient's satisfaction

    Time frame: 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.

    Arbitrary Likert scale 0-5

  3. Patient's experience of pain

    Time frame: 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.

    Numerical Rating Scale (NRS) scale 0-10

  4. Durability

    Time frame: 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.

    Is the chemotherpy session completed successfully (yes/no). Defined as intravenous chemotherapy successfully infused with only one peripheral intravenous catheter used.

  5. Intravenous complications

    Time frame: 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.

    Intravenous complications such as e.g., infiltration, extravasation, vessel occlusion etc.

Study contacts

Contact information is provided by the study sponsor or research team.

Lisa Maria Anderssen, RN, MHS

CONTACT

[email protected]

(+298) 223820

Maria Skaalum Petersen, MSc, PhD

CONTACT

[email protected]

(+298) 216695

Sponsors and collaborators

Lead sponsor

Faroese Hospital System

Other

Collaborators

  • National Hospital of the Faroe Islands
  • University of Aarhus
  • University of the Faroe Islands

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Aug 29, 2024
Registry last updated
Aug 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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