Skip to main content
OpenTrials
Completed

NCT Number: NCT06290284

Comparison Between Mini-midline and the Peripheral Intravenous Catheter

The goal of this randomized controlled trial is to investigate the difference between LPC (mini-midline) and PIVC (peripheral venous catheter) on the need of further venipuncture for blood withdrawal or placement of a new vascular access.

The main questions it aims to answer are:

* Whether the number of patients with LPC and PIVC differ in terms of repeated venipunctures; * Whether the number of patients with LPC and PIVC differ in terms of adverse events associated with the use of such vascular catheters.

Researchers will compare the proportion of patients with repeated venipunctures between LPC and PIVC arms.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Vascular Access Devices Disease Attributes Emergencies Pathologic Processes Pathological Conditions, Signs and Symptoms Venous Puncture

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, 20122, Italy

About this study

A standard peripheral intravenous catheter (PIVC) or a mini-midline (LPC) will be placed according to routine clinical indications (i.e., for blood withdrawal and IV drug therapy) in patients seeking care at the Emergency Department. On admission at the Emergency Department triage desk, patients will be assigned a triage code according to clinical assessment by the triage nurse and will be evaluated as to the probability of being eventually admitted to hospital. Following enrollment, patients will be randomly assigned to receive LPC or PIVC. The follow-up period begins after catheter placement and continues through transfer to a hospital ward. During this period of catheter management, the insertion site and dressing will be monitored.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥ 18 years
  • High probability of hospital admission
  • Sufficient venous patrimony according to EA-DIVA scale score

Exclusion criteria

  • Patients already having a venous access in place
  • Patients requiring life-saving treatments
  • Patients seeking ambulatory care
  • Patients unable to express informed consent

Treatment and study plan

Long Peripheral Catheter

Procedure

PowerGlide Pro™ Midline Catheter

Peripheral Intra-Venous Catheter

Procedure

Venflon™ Pro Safety Needle Protected IntraVenous Cannula

Primary outcomes

  1. Difference in proportion

    Time frame: The catheter will be evaluated within 24 hours after the placement

    Difference between the two study arms in the proportion of patients who required a venipuncture after insertion of the PIVC or the LPC.

Secondary outcomes

  1. Adverse events associated with use of LPC and PIVC

    Time frame: Adverse will be evaluated every 24 hours till the catheter removal

    Number of adverse events (e.g., thrombophlebitis, extravasation, inflammation of the insertion site) monitored also using the Visual Infusion Phlebitis Score

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Other

Registry information

Official study title

Comparison Between the Long (Mini-midline) and the Short Catheter (Peripheral Intravenous Catheter) in the Reduction of Venipunctures During Hospital Stay: a Randomized Controlled Trial

Acronym: INSERT/2022

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 4, 2024
Registry last updated
Mar 4, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.