Effectiveness of a Needle-free Connector With Anti-reflux Technology in Reducing Complications From Long Peripheral Venous Catheters in Hospitalised Adult Patients: Randomised Clinical Trial

ConditionsVascular Access Devices Catheters Occlusion Thrombosis Randomised Controlled Trial

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

AgeNot listed

SponsorHospital Arnau de Vilanova

About this trial

A study to evaluate a needle-free connector (a stopper) featuring anti-reflux technology (to prevent blood from flowing back) for catheters (polyurethane tubes inserted into a vein), with the aim of reducing complications associated with these devices: blockages, infections, pain, etc.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients requiring placement of a long peripheral venous catheter.

Patients who have provided written informed consent.

Patients with an expected hospital stay of ≥7 days.

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

Needle-free connector with neutral fluid displacement and without anti-reflux technology
Procedure/Surgery
Placement of a needle-free connector with neutral fluid displacement and no anti-reflux technology onto a long PVC.
Needle-free connector with neutral fluid displacement and equipped with anti-reflux technology
Procedure/Surgery
Placement of a needle-free connector featuring neutral fluid displacement and anti-reflux technology onto a long PVC.
Long peripheral venous catheter
Device
Placement of a 20-gauge long PVC in an arm vein using the AST.
Ultrasound scanner
Other intervention
All punctures will be performed under ultrasound guidance.

Treatment groups

62 Participants

are divided into 2 treatment groups

Group A: Needle-free connector without anti-reflux technologyActive comparator 3 interventions

Group B: Needle-free connector with anti-reflux technologyExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

Number of participants who experienced device-related adverse events, classified according to CTCAE v5.0.

Percentage of participants experiencing adverse events following insertion of a long peripheral venous catheter and placement of a needle-free connector featuring neutral fluid displacement and anti-reflux technology (Clave™ Neutron™, Ref. 011-NC139).

Time frame

7 days

Secondary outcomes

Number of participants with partial or complete occlusions in long peripheral venous catheters, as assessed using the CINAS scale (UZ Leuven®).

To determine the total number of partial and complete occlusions in long peripheral venous catheters in adult inpatients during the acute phase of illness within the first seven days after insertion of either a needle-free connector featuring neutral fluid displacement and anti-reflux technology (Clave™ Neutron™) or a neutral connector without this technology.

Time frame

7 days

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hospital Arnau de Vilanova

Lead sponsor

Official College of Nurses of Lleida

Collaborator

Department of Health, Generalitat de Catalunya (PERIS)