Clinical trial NCT06290284: Comparison Between Mini-midline and the Peripheral Intravenous Catheter
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vascular Access Devices
Venous Puncture
Keywords: Vascular access
Emergency Department
Long Peripheral Catheter
Peripheral Intra-Venous Catheter
Lead sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Sponsor class: OTHER
First posted: 2024-03-04
Enrollment: 294
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Difference in proportion
timeFrame: The catheter will be evaluated within 24 hours after the placement
Secondary outcomes:
measure: Adverse events associated with use of LPC and PIVC
timeFrame: Adverse will be evaluated every 24 hours till the catheter removal
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Study officials:
affiliation: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
name: Alessandro Galazzi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.