Comparison Between Mini-midline and the Peripheral Intravenous Catheter

NCT06290284 | Completed

• 1 other identifier: 6322
• Study Type: interventional
• Target: 294
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Vascular Access Devices; Venous Puncture

Keywords

Vascular access; Emergency Department; Long Peripheral Catheter; Peripheral Intra-Venous Catheter

Outcome Measures

Primary Outcomes (1)

• Difference in proportion

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

  The catheter will be evaluated within 24 hours after the placement

Secondary Outcomes (1)

• Adverse events associated with use of LPC and PIVC

  Adverse will be evaluated every 24 hours till the catheter removal

Study Arms (2)

Long Peripheral Catheter

EXPERIMENTAL

The procedure to place a LPC includes these steps: before inserting the catheter, the nurse will perform routine preliminary (non sterile) inspection of the arm to identify an insertion site. After selecting the insertion site, the nurse will release the tourniquet, with non-sterile gloves, and disinfect the skin around the insertion site. While allowing the antiseptic to act, the nurse will apply the tourniquet, and pull lightly with the thumb of the non-dominant hand to keep the vein from moving. After the needle has been inserted in the vein lumen, the guide wire is advanced and the catheter is inserted using the catheter wings. As the catheter is being inserted, the sheath (housing) is removed and then the wings. Before attaching the catheter to an extension without a needle or to a 3-way stopcock, it should be connected to a statlock to ensure it is safely fixated. A transparent, semi-permeable dressing will allow for daily visual inspection of the insertion site.

Procedure: Long Peripheral Catheter

Peripheral Intra-Venous Catheter

ACTIVE COMPARATOR

The procedure to place a PIVC includes these steps: before inserting the catheter, the nurse will perform routine preliminary (non sterile) inspection of the arm to identify an insertion site. After selecting the insertion site, the nurse will release the tourniquet, with non-sterile gloves, and disinfect the skin around the insertion site. While allowing the antiseptic to act, the nurse will apply the tourniquet, and pull lightly with the thumb of the non-dominant hand to keep the vein from moving. The needle will be inserted at a 10-30 degree angle about 1-2 cm distal from the catheter insertion site. Holding the needle firmly, the nurse will advance the cannula for its entire length into the lumen, remove the needle, and connect the cannula via an extension to a 3-way stopcock. A transparent, semi-permeable dressing will allow for daily visual inspection of the insertion site.

Procedure: Peripheral Intra-Venous Catheter

Interventions

Long Peripheral Catheter PROCEDURE

PowerGlide Pro™ Midline Catheter

Long Peripheral Catheter

Peripheral Intra-Venous Catheter PROCEDURE

Venflon™ Pro Safety Needle Protected IntraVenous Cannula

Peripheral Intra-Venous Catheter

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: lead

Study Sites (1)

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, 20122, Italy

Location

Related Publications (2)

• Civetta G, Cortesi S, Mancardi M, De Pirro A, Vischio M, Mazzocchi M, Scudeller L, Bottazzi A, Iotti GA, Palo A. EA-DIVA score (Enhanced Adult DIVA score): A new scale to predict difficult preoperative venous cannulation in adult surgical patients. J Vasc Access. 2019 May;20(3):281-289. doi: 10.1177/1129729818804994. Epub 2018 Oct 16.

  PMID: 30324841 BACKGROUND

• Binda F, Galazzi A, Marelli F, Salinaro G, de Vecchi M, Spagna S, Marcotullio A, Calegari J, Laquintana D, Gambazza S. Long versus conventional peripheral intravenous catheters to reduce venipunctures during hospital stay: A randomized controlled trial. J Vasc Access. 2025 Nov 3:11297298251385595. doi: 10.1177/11297298251385595. Online ahead of print.

  PMID: 41185485 DERIVED

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alessandro Galazzi, PhD

  Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The statistician will be provided an anonymized dataset.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: January 31, 2024
• First Posted: March 4, 2024
• Study Start: September 25, 2023
• Primary Completion: November 17, 2023
• Study Completion: December 28, 2023
• Last Updated: March 4, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)