Comparison Between Mini-midline and the Peripheral Intravenous Catheter

NCT ID: NCT06290284

Last Updated: 2024-03-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 294 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-25
• Study Completion Date: 2023-12-28

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.

Conditions

Vascular Access Devices; Venous Puncture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Long Peripheral Catheter

Intervention Type: PROCEDURE

PowerGlide Pro™ Midline 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.

Group Type: ACTIVE_COMPARATOR

Peripheral Intra-Venous Catheter

Intervention Type: PROCEDURE

Venflon™ Pro Safety Needle Protected IntraVenous Cannula

Interventions

Long Peripheral Catheter

PowerGlide Pro™ Midline Catheter

Intervention Type: PROCEDURE

Peripheral Intra-Venous Catheter

Venflon™ Pro Safety Needle Protected IntraVenous Cannula

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

OTHER

Sponsor Role: lead

Responsible Party

Alessandro Galazzi

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alessandro Galazzi, PhD

Role: PRINCIPAL_INVESTIGATOR

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Locations

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, , Italy

Countries

Italy

References

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.

Reference Type: BACKGROUND

PMID: 30324841 (View on PubMed)

Other Identifiers

6322

Identifier Type: -

Identifier Source: org_study_id