NCT06578494

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2024

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 20, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 29, 2024

Completed
18 days until next milestone

Study Start

First participant enrolled

September 16, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 16, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 16, 2026

Completed
Last Updated

August 29, 2024

Status Verified

August 1, 2024

Enrollment Period

1.1 years

First QC Date

August 20, 2024

Last Update Submit

August 27, 2024

Conditions

Keywords

UltrasonographyIntravenousOncology

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Number of skin punctures

    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

    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

    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

    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

    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.

Study Arms (2)

Ultrasound-guided peripheral intravenous access

EXPERIMENTAL

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

Traditional palpation intravenous access technique

ACTIVE COMPARATOR

The comparator group will receive the traditional palpation intravenous access technique.

Device: Ultrasound

Interventions

Ultrasound-guided peripheral intravenous catheter insertion

Traditional palpation intravenous access techniqueUltrasound-guided peripheral intravenous access

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Lack of informed consent and mental incapacity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Neoplasms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa Maria Anderssen, RN, MHS

CONTACT

Maria Skaalum Petersen, MSc, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
FACTORIAL
Model Details: This is a before and after study, where the patients pre-implementation stage receive intravenous access via the traditional palpation technique and in the post-implementation stage receive ultrsound-guided intravenous cannulation.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2024

First Posted

August 29, 2024

Study Start

September 16, 2024

Primary Completion

October 16, 2025

Study Completion

February 16, 2026

Last Updated

August 29, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

IPD data can be shared on a collaborative basis, provided the appropriate approvals