Comparison Between Mini-midline and the Peripheral Intravenous Catheter (INSERT/2022)

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

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.

Study Overview

• Status: Completed
• Conditions: Venous Puncture; Vascular Access Devices
• Intervention / Treatment: Procedure: Long Peripheral Catheter; Procedure: Peripheral Intra-Venous Catheter

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 294
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy, 20122
    • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Long Peripheral Catheter; 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; PowerGlide Pro™ Midline Catheter
Active Comparator: Peripheral Intra-Venous Catheter; 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; Venflon™ Pro Safety Needle Protected IntraVenous Cannula

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events associated with use of LPC and PIVC	Number of adverse events (e.g., thrombophlebitis, extravasation, inflammation of the insertion site) monitored also using the Visual Infusion Phlebitis Score	Adverse will be evaluated every 24 hours till the catheter removal

Collaborators and Investigators

• Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
• Investigators: Principal Investigator: Alessandro Galazzi, PhD, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2023
• Primary Completion (Actual): November 17, 2023
• Study Completion (Actual): December 28, 2023

Study Registration Dates

• First Submitted: January 31, 2024
• First Submitted That Met QC Criteria: March 1, 2024
• First Posted (Estimated): March 4, 2024

Study Record Updates

• Last Update Posted (Estimated): March 4, 2024
• Last Update Submitted That Met QC Criteria: March 1, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Emergency Department; Vascular access; Long Peripheral Catheter; Peripheral Intra-Venous Catheter
• Other Study ID Numbers: 6322

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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