Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2025-12-24 @ 10:48 PM
NCT ID:
NCT02134769
Brief 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.
Study:
NCT02134769
Study Brief:
Protocol Section:
NCT02134769