Comparison Between Mini-midline and the Peripheral Intravenous Catheter

Vascular Access Devices Clinical Trial

— INSERT/2022  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06290284
• Other study ID #: 6322
• Status: Completed
• Phase: N/A
• Start date: September 25, 2023
• Est. completion date: December 28, 2023

Study information

• Verified date: March 2024
• Source: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 294
• Est. completion date: December 28, 2023
• Est. primary completion date: November 17, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Vascular Access Devices
• Venous Puncture

Intervention

Procedure:
• Long Peripheral Catheter
PowerGlide Pro™ Midline Catheter
• Peripheral Intra-Venous Catheter
Venflon™ Pro Safety Needle Protected IntraVenous Cannula

Locations

Country	Name	City	State
Italy	Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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