Influence of Bionecteurs on Catheter-associated Infection

Not Applicable

Completed

• Conditions: Infection
• Interventions: Device: Bionecteur

• Registration Number: NCT02134769
• Lead Sponsor: University Hospital Tuebingen

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 Timeline

• Study First Submitted: 2014-04-09
• Study First Submitted QC: 2014-05-07
• Study First Posted: 2014-05-09
• Study Start: 2014-08
• Status Verified: 2015-07
• Primary Completion: 2015-11
• Study Completion: 2015-12
• Last Update Submitted: 2016-11-11
• Last Update Posted: 2016-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 221

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bionecteur	Bionecteur	Use of Bionecteur; handling according to institutional guideline

Primary Outcome Measures

Name	Time	Method
Incidence of catheter-related bloodstream infections using Bionecteurs	1 year

Secondary Outcome Measures

Name	Time	Method
Length of Stay in ICU	1 year	Determine days in ICU with centrral venous catheter

Trial Locations

Locations (1)

University Hospital Tuebingen; 🇩🇪 Tuebingen, Germany