Influence of Bionecteurs on Catheter-associated Infection

Study Overview
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Brief Summary
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Bionecteur® is a protective non-touch applicator to ensure aseptic connection made by Vygon. However, there are no studies describing a positive effect of using Bionecteurs ® in regard to catheter-related bloodstream infections. In this study Bionecteur® will be used on central venous lines and arterial lines in postoperative patients of a 40-bed ICU. The incidence of catheter-related bloodstream infections will we compared to patients without inclusion of Bionecteur® devices.

Detailed Description
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Prospective, randomised observational study Postsurgical patients in an anesthesiological ICU with ICU LOS (LOS: length of stay) > 3 days Inclusion: ---- Age ≥ 18 years ---. demand of central venous and arterial line --- written consent of patient and/or assignee Exclusion Handicapped patients patient with ICU LOS < 3 days Study design Three days after admission to ICU blood cultures are drawn to exclude preexisting blood stream infection Patients in a bed with even number are assigned to Bionecteur® group. Control group (without using bionecteurs) are patients with an odd bed number. Biconecteurs® are connected to all lumens of the central catheter and to arterial catheter. Control group is treated without using Bionecteurs®. Handling of vascular catheters are performed as described in institutional guidelines in both groups. Catheter-related bloodstream infections are monitored by an independent person during ICU treatment The study will be finished ab discharge of ICU or removal of catheters.

Official Title
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Incidence of Catheter-related Bloodstream Infections Using Bionecteur Device

Conditions
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Infection

Intervention / Treatment
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* Device: Bionecteur


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Length of Stay (LOS) in ICU > 3 days written consent by patient or notarial carers medical indication for central venous line/arterial line Exclusion Criteria: handicap LOS ICU < 3 days no consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>No use of Bionecteur; handling according to institutional guideline | |
| Active Comparator: Bionecteur<br>Use of Bionecteur; handling according to institutional guideline | Device: Bionecteur<br>* Using Bionecteur at each lumina of the catheter; handling according to institutional guideline<br>* Other names: bionector® company: Vygon;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of catheter-related bloodstream infections using Bionecteurs |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of Stay in ICU | Determine days in ICU with centrral venous catheter | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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catheter-related bloodstream infections