NCT02134769

Influence of Bionecteurs on Catheter-associated Infection

Incidence of Catheter-related Bloodstream Infections Using Bionecteur Device

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 221 (actual)
• Sponsor: University Hospital Tuebingen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

* 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 1. Three days after admission to ICU blood cultures are drawn to exclude preexisting blood stream infection 2. Patients in a bed with even number are assigned to Bionecteur® group. Control group (without using bionecteurs) are patients with an odd bed number. 3. 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. 4. Catheter-related bloodstream infections are monitored by an independent person during ICU treatment 5. The study will be finished ab discharge of ICU or removal of catheters.

Conditions

• Infection

Interventions

Type	Name	Description
DEVICE	Bionecteur	Using Bionecteur at each lumina of the catheter; handling according to institutional guideline

Timeline

• Start date: 2014-08-01
• Primary completion: 2015-11-01
• Completion: 2015-12-01
• First posted: 2014-05-09
• Last updated: 2016-11-15

Locations

1 site across 1 country: Germany