Catheters, Occlusion, Randomised Controlled Trial, Thrombosis, Vascular Access Devices
Conditions
Keywords
Needleless connector
Brief summary
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.
Detailed description
Introduction: Long peripheral venous catheters (PVCs) are a suitable alternative to short PVCs, midline catheters (MLCs) and central venous catheters (CVCs), particularly in patients with difficult intravenous access (DIVA), due to their characteristics: they are between 6 and 15 centimetres in length, have a gauge of 18 to 22 gauge (G), and do not extend beyond the axillary vein. Hypothesis: The use of a needle-free connector with neutral fluid displacement and equipped with anti-reflux technology (Clave™ Neutron™) in long PVCs in adult inpatients with acute conditions reduces the number of catheter failures during the first seven days compared with a neutral-displacement needle-free connector without an anti-reflux valve. Objective: To evaluate the efficacy of using a needle-free connector with neutral fluid displacement and equipped with anti-reflux technology (Clave™ Neutron™) following the insertion of long PVCs in adult inpatients in the acute phase of their illness during the first seven days. Methodology: A clinical study involving two randomised groups will be conducted prior to catheter placement. The control group will receive treatment using a needle-free connector with neutral fluid displacement and without an anti-reflux valve (Microclave® Clear, Ref. 011-MC3302). The intervention group will receive treatment using a needle-free connector with neutral fluid displacement and equipped with anti-reflux technology (Clave™ Neutron™, Ref. 011-NC139). Expected results: It is expected that the incidence of complications associated with long PVCs in hospitalised adult patients will be reduced following the standardised implementation of a needle-free connector with neutral fluid displacement and equipped with anti-reflux technology (Clave™ Neutron™) during the initial phase of treatment. Specifically, a reduction in the incidence of catheter obstructions and CRBSI is anticipated. Clinical implication: The study will contribute to optimising decision-making regarding catheter maintenance and related therapeutic measures, with the aim of reducing the main complications associated with them.
Interventions
PROCEDURENeedle-free connector with neutral fluid displacement and without anti-reflux technology
Placement of a needle-free connector with neutral fluid displacement and no anti-reflux technology onto a long PVC.
PROCEDURENeedle-free connector with neutral fluid displacement and equipped with anti-reflux technology
Placement of a needle-free connector featuring neutral fluid displacement and anti-reflux technology onto a long PVC.
Placement of a 20-gauge long PVC in an arm vein using the AST.
OTHERUltrasound scanner
All punctures will be performed under ultrasound guidance.
Sponsors
Hospital Arnau de Vilanova
Official College of Nurses of Lleida
Department of Health, Generalitat de Catalunya (PERIS)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Researchers will be responsible for catheter insertion and subsequent data collection; however, patients will be blinded to the type of needle-free connector used (with or without anti-reflux technology). In addition, the results will be evaluated by an independent researcher who is not involved in the data collection process.
Intervention model description
A classic parallel-group design will be used, consisting of an intervention group and a control group. The intervention group will receive catheters fitted with a needle-free connector featuring neutral fluid displacement and anti-reflux technology (Clave™ Neutron™, Ref. 011-NC139), whereas the control group will receive a needle-free connector with neutral fluid displacement but without anti-reflux technology (Microclave® Clear, Ref. 011-MC3302).
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
\- Inability to place a long peripheral venous catheter in the upper limbs.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants who experienced device-related adverse events, classified according to CTCAE v5.0. | 7 days | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with partial or complete occlusions in long peripheral venous catheters, as assessed using the CINAS scale (UZ Leuven®). | 7 days | 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. |
Contacts
CONTACTPadilla-Nula F PhD candidate, Nurse
Outcome results
None listed