Comparison Between Mini-midline and the Peripheral Intravenous Catheter

Not Applicable

Completed

• Conditions: Venous Puncture; Vascular Access Devices
• Interventions: Procedure: Long Peripheral Catheter; Procedure: Peripheral Intra-Venous Catheter

• Registration Number: NCT06290284
• Lead Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

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.

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 Timeline

• Study Start: 2023-09-25
• Primary Completion: 2023-11-17
• Study Completion: 2023-12-28
• Study First Submitted: 2024-01-31
• Status Verified: 2024-03
• Study First Submitted QC: 2024-03-01
• Last Update Submitted: 2024-03-01
• Study First Posted: 2024-03-04
• Last Update Posted: 2024-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 294

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Long Peripheral Catheter	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.
Peripheral Intra-Venous Catheter	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.

Primary Outcome Measures

Name	Time	Method
Difference in proportion	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 Outcome Measures

Name	Time	Method
Adverse events associated with use of LPC and PIVC	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

Trial Locations

Locations (1)

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico; 🇮🇹 Milan, Italy